Musculoskeletal Science and Practice 45 (2020) 102070

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Musculoskeletal Science and Practice

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Original article

Effectiveness of deep tissue massage therapy, and supervised strengthening

and stretching exercises for subacute or persistent disabling neck pain. The
Stockholm Neck (STONE) randomized controlled trial
Eva Skillgate a, b, 1, Oscar Javier Pico-Espinosa a, *, 1, Pierre Co
^t�e c, Irene Jensen d,
Peter Viklund a, b, Matteo Bottai e, Lena W. Holm a
a
Musculoskeletal and Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
b
Naprapath€ ogskolan – Scandinavian College of Naprapathic Manual Medicine, Stockholm, Sweden
c
Faculty of Health Sciences and UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology, Toronto,
Canada
d
Unit of Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
e
Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden

A R T I C L E I N F O A B S T R A C T

Keywords: Objective: To compare the effectiveness of deep tissue massage, supervised strengthening and stretching exercises,
Neck pain and a combined therapy (exercise followed by massage) (index groups), with advice to stay active (control
Musculoskeletal manipulations group).
Manual therapies
Methods: Randomized controlled trial of 619 adults with subacute or persistent neck pain allocated to massage
Patient education
(n ¼ 145), exercise (n ¼ 160), combined therapy (n ¼ 169) or advice (n ¼ 147). Primary outcomes were minimal
Complementary therapies/methods
Treatment outcome clinically important improvements in neck pain intensity and pain-related disability based on adapted questions
from the Chronic Pain Questionnaire. Secondary outcomes were perceived recovery and sickness absence.
Outcomes were measured at seven, 12, 26 and 52 weeks.
Results: We found improvement in pain intensity favouring massage and combined therapy compared to advice;
at seven weeks (RR ¼ 1.36; 95%CI:1.04–1.77) and 26 weeks (RR ¼ 1.23; 95%CI:0.97–1.56); and seven
(RR ¼ 1.39; 95%CI:1.08–1.81) and 12 weeks (RR ¼ 1.28; 95%CI:1.02–1.60) respectively, but not at later follow-
ups. Exercise showed higher improvement of pain intensity at 26 weeks (RR ¼ 1.31; 95%CI:1.04–1.65).
Perceived recovery was higher in the index groups than in the advice group at all follow-ups. We found no
consistent differences in pain related disability or sickness absence.
Conclusions: In this study, at 12-months follow-up, none of the index therapies were more effective than advice in
terms of pain intensity in the long term or in terms of pain-related disability in the short or long term. However,
the index therapies led to higher incidence of improvement in pain intensity in the short term, and higher
incidence of favorable perceived recovery in the short and in the long term than advice.
Trial registration: ISRCTN01453590. Registered 3 July 2014.

1. Introduction Hansson, 2005). Personal, clinical, and psychosocial factors influence its
prognosis (Carroll et al., 2008a, 2008b, 2008c). Therefore, the clinical
Neck pain is a leading cause of disability worldwide and its burden management of neck pain is challenging and few scientifically proven
continues to grow due to its high frequency among working population, effective treatments are available to assist clinicians in the choice of care
which translates into high costs due to sick absence and productivity loss of the patients (Guzman et al., 2008; Wong et al., 2016). In the past,
(Fejer et al., 2006; Global burden of disease, 2015; Hansson and research on clinical interventions focused on pain relief and failed to

* Corresponding author. Musculoskeletal and Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-17177,
Stockholm, Sweden.
E-mail address: [email protected] (O.J. Pico-Espinosa).
1
Share first authorship.

https://doi.org/10.1016/j.msksp.2019.102070
Received 13 May 2019; Received in revised form 25 September 2019; Accepted 8 October 2019
Available online 14 October 2019
2468-7812/© 2019 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

consider the multifaceted prognosis of neck pain including patient which they contacted the study coordinator, who made a first assess­
centered outcomes. Therefore, research supports that effective clinical ment of inclusion/exclusion criteria by phone, and filled out part one of
interventions must target pain relief, promote active coping and reassure the baseline questionnaire (baseline questionnaire A) after participants
patients without promoting iatrogenic disability. Previous studies sug­ had given their informed oral consent. Those who fulfilled this part were
gest that educational interventions, exercise training, mobilization, referred to the research clinic set up in the Scandinavian College of
manipulation, analgesics, acupuncture and low-level laser may provide Naprapathic Manual Medicine in Stockholm for an appointment within
short-term benefits (Guzman et al., 2008; Wong et al., 2016). a week. All study participants received written information about the
Non-specific neck pain has multifaceted etiology and is commonly trial at enrolment.
managed with massage and exercise. Various local and systemic mech­ At the clinic, the study participants filled out part two of the baseline
anisms of action have been proposed to describe the effect of massage in questionnaire (baseline questionnaire B). Then, they underwent a clin­
the treatment of pain, including reorganization of muscle fibers, ical examination, were included in the trial if they met the inclusion/
improvement of circulation and influence on the immune function exclusion criteria based on the therapist’s clinical judgement and finally,
(Weerapong et al., 2005; Rapaport et al., 2012). For exercise, some the envelope with the assigned number of the study participant was
described mechanisms include increased proprioception, muscle acti­ opened by the therapist, and the result of the randomization was
vation and increased strength (Koltyn et al., 2014; Runhaar et al., 2015) revealed and treatment started immediately. A more detailed descrip­
The literature suggests that deep tissue massage or clinical massage tion of the procedures is presented in the study protocol (Skillgate et al.,
together with advice may be helpful for neck pain, but the evidence 2015).
supporting such intervention is weak (Guzman et al., 2008; Wong et al.,
2016). Similarly, supervised strengthening, range-of-motion and flexi­ 2.3. Interventions
bility exercises are more effective than a waiting list, but strengthening
exercises alone are not superior to home range-of-motion or stretching The interventions (deep tissue massage, strengthening and stretching
exercises (Southerst et al., 2014). In summary, the long term effect of exercises, combined therapy of deep tissue massage and strengthening
these commonly used interventions on disabling neck pain needs to be and stretching exercise and, advice to stay active) are described in detail
further evaluated. in Appendix A. The interventions were delivered by 30 therapists with
We designed a randomized clinical trail with the aim to compare the experience in massage and exercise therapy. These therapists were not
effectiveness of deep tissue massage, supervised strengthening exercise part of the research team. All therapists were either naprapathy students
and stretching, and a combined therapy (exercise followed by deep or licenced naprapaths (manual medicine professionals who focus on
tissue massage) versus advice to stay active in patients with subacute or management of pain and disability in the musculoskeletal system). Both
persistent neck pain. We hypothesized that deep tissue massage and/or massage therapy and strengthening and stretching exercises are
supervised strengthening exercise and stretching would lead to greater commonly used by naprapaths in the management of musculoskeletal
reduction in pain intensity, pain-related disability and improvement in pain. For students of naprapathy to be able to participate in the provi­
perceived recovery and a lower risk of sickness absence. sion of the interventions within the trial, they must have had at least 3
years of experience in the field of the interventions (for example, as
2. Materials and methods masseur or personal trainer). Prior to trial start, all therapists received
two sessions of 3 h each with a standardized training in delivering all
2.1. Study design, setting and participants four interventions. In addition, follow-up meetings took place once
every semester (and if needed) to ensure adherence to the protocols. The
The trial was registered in the ISRCTN registry on 3 July 2014 intensity of therapy was adapted to the needs of the patient. The treat­
(ISRCTN01453590). Participants enrolled in the Stockholm Neck Trial ment duration was six weeks and the number of visits was limited to six
(STONE trial) (Skillgate et al., 2015) were recruited between September for massage, exercise and combined therapy, and three for the advice
2014 and December 2015. This was done through advertisements in a group.
free daily newspaper of high circulation in Stockholm and, by internal
advertising among employees in the public sector. We included in­ 2.4. Deep tissue massage therapy
dividuals aged 18–70 years with subacute (30–90 days duration) or
chronic (�90 days duration) non-specific disabling neck pain with or Deep tissue massage therapy included techniques tailored to pain
without headache and/or radiating symptoms. Those with pain intensity symptomatology (Ernst et al., 2006). The massage targeted the painful
<2/10 and disability <1/10 on Numerical Rating Scales (NRS) were not area (upper back and neck, and if indicated, also jaw and/or chest) and
included (Von Korff et al., 1992). Further, those with a history of cancer was delivered to tolerance, so that it was perceived as beneficial without
(past five years), pregnancy, severe skin disorders, sickness absence reaching pain intensity exceeding 5/10. Techniques varied from
related to neck surgery, prolapsed disc, spondylolisthesis, fracture, spi­ effleurage to firm motion involving compression and pressure release,
nal stenosis, arthritis, osteoporosis, recent neck trauma (in the past and deep muscle/fascia massage to areas that produced concordant
48 h), severe night pain, steroids use, drug abuse, pain debuting after 55 signs. Sessions lasted 45 min, including 10 min for anamnesis.
years, having received treatment by a manual therapist for the current
complaint, signs of infection (Sizer et al., 2007), without access to a 2.5. Supervised strengthening and stretching exercises therapy
smartphone with connection to internet and those not being able to
communicate in Swedish were not included. This therapy consisted of the following: cranio-cervical flexion ex­
ercises for activation of m. longus colli and m. rectus capitis; push-ups
2.2. Randomization for strengthening of m. pectoralis major, m. pectoralis minor and asso­
ciated chest musculature; lying pulldowns for strengthening of m. ser­
Prior to the study start, an independent research coordinator pre­ ratus anterior and m. trapezius pars ascendens; isometric exercises for
pared 800 sequentially numbered sealed envelopes in blocks of 160 strengthening of deep extensors of the neck; contraction of m. trapezius
containing one of the three index groups (deep tissue massage, pars ascendens and; stretching of m. pectoralis major, m. pectoralis
strengthening and stretching exercises or, combined therapy) or the minor, m. masseter, m. temporalis and mm. pterygoidei. The exercises
reference group (40 each). Cards indicating the treatment arm were were supervised by the therapist and delivered at three levels of in­
placed in a sealed urn and randomly selected one by one to be placed in tensity depending on participants’ ability, tolerance, stamina, activities
the envelopes. Participants were numbered according to the order in of daily living and aiming to provide the most benefits. We instructed

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

participants to repeat the exercises at home once or twice per week. To the previous follow-up period were classified as having had a sickness
assist with compliance, we filmed participants and gave comments when absence.
doing the exercises at the clinic (on their smartphone) to use at home.
Sessions lasted 45 min, including 10 min for anamnesis. 2.11. Adverse events

2.6. Deep tissue massage therapy and supervised exercise therapy We measured adverse events at every return visit to the clinic with a
questionnaire.
This group received exercise therapy followed by massage according
the protocols described above but allocating 25 min to each modality 2.12. Sample size
instead (50 min in total). Additional 10 min were used for anamnesis.
Based on results from our previous research (Skillgate et al., 2010),
2.7. Advice to stay active we estimated a sample size of 600 subjects (150 in each group) to detect
a relative risk of 1.2–1.3 at twelve months for MCII in pain intensity and
Our control intervention was advice to stay active. Participants disability with a power of 80% and an alpha level of 0.05.
allocated to this group had a motivating discussion with the therapist,
based on a booklet they received. They attended up to three visits with a 2.13. Statistical analysis
therapist. The booklet included evidence-based information about back
and neck pain (Jensen et al., 2004). The advice aimed to educate par­ All analyses followed the intention to treat approach. To describe the
ticipants about the common occurrence of back and neck pain, the population, we calculated the mean and the standard deviation for
psychology of the condition, the misconceptions about back and neck normally distributed continuous variables, the median and the inter­
pain and the importance of returning to normal activities. The visits with quartile range for not-normally distributed continuous variables and
the therapist aimed to personalize the education and discussion to the proportions for categorical and dichotomous variables. For the primary
participant’s condition. Finally, participants were informed about when outcomes, results are reported as the proportion of participants
to seek care. Sessions lasted 30 min, including 10 min for anamnesis. achieving MCII (�2/10 for pain, and �1/10 for disability). We used
generalized estimating equations (GEE) with binomial family and log
2.8. Data collection and follow-up measurements link function to analyze the effect of the therapies. We used an
exchangeable correlation structure (Twisk, 2013) and included an
Questionnaires were filled in at baseline including values for the interaction term between treatment and time in the model. Thereafter,
primary and secondary outcomes and an extensive number of cova­ we did a linear combination of estimators (Stata Lincom command
riates. We measured the primary outcomes and perceived recovery using (StataCorp, 2015)) using the estimates of treatment, time and the
web-based questionnaires at weeks 7, 12, 26 and 52. Information on interaction term. The results are presented as relative risks (RR) with
sickness absence was collected at baseline and at 12, 26 and 52 weeks. 95% confidence intervals (CI). In addition, Number Needed to Treat
(NNT) was calculated for the primary and secondary outcomes as the
2.9. Primary outcomes inverse of the difference in proportions between each of the groups and
advice to stay active (NNT ¼ 1/EER-CER, where EER is “experimental
Pain intensity and pain related disability in the past four weeks were event rate” (in this case, proportion in the massage, exercises or com­
measured with an adapted version of the Chronic Pain Grade ques­ bined therapy group) and CER is “control event rate” (in this case, pro­
tionnaire (CPQ) (Von Korff et al., 1992; Smith et al., 1997; Paanalahti portion in the advice group)). The NNT indicates how many participants
et al., 2016; Skillgate et al., 2007). We modified the recall period from one would need to treat with the index treatment (massage, exercises or
six months to four weeks to improve the reliability and match with the combined therapy) instead of the reference treatment (advice) to ach­
frequency of our follow-ups. The original classification in grades of pain ieve one successful case. High values indicate small differences (should
was therefore, not possible to perform. In the CPQ, pain intensity is be interpreted as “many persons need to be treated with the index
measured with three items (current, worst and average pain) and treatment instead of the reference treatment in order to obtain an
pain-related disability is also measured with three items (pain interfer­ additional case of recovery”). Negative values indicate lower proportion
ence with daily activities; with the ability to participate in recreational, of the outcome than advice to stay active. All analyses were conducted
social and family activities; and the ability to work, including house­ using STATA 14.0 (StataCorp, 2015).
work). All items were answered with a number between 0 and 10 The trial was approved by the Regional Ethic Committee in Stock­
(NRS-11, where 0 meant no pain at all and 10 maximum imaginable holm (Dnr: 2014/755-31/3).
pain. For pain-related disability, 0 meant No interference/no change and
10 Unable to carry on activities/extreme change). A mean score was 3. Results
constructed for pain intensity and one for pain-related disability. We
calculated the difference between the mean scores at baseline and each We screened 1514 individuals and enrolled 621 participants (Fig. 1).
follow-up. We used the literature (Kovacs et al., 2008) to define the Treatment group characteristics were similar at baseline (Table 1). The
primary outcomes: minimal clinically important improvement (MCII) as 52-weeks follow-up rate was highest for massage therapy (94%) and
a reduction of �2/10 for pain, and of �1/10 for pain-related disability. lowest for advice to stay active (79%). The average age of the sample
was 46 years and 69% were women. Most participants reported pain
2.10. Secondary outcomes duration of more than 12 months and 77% used medication for their
pain (Table 1). The average number of visits was 2.4 for advice to stay
Self-perceived recovery was measured with a global perceived effect active, 5.8 for massage, 5.0 for exercise and 5.5 for massage and
scale by asking: “How do you feel your symptoms in the neck have changed exercise.
since you joined the study?” (Kamper et al., 2010; Dworkin et al., 2005;
van der Windt et al., 1998) Participants who reported to be significantly 3.1. Primary outcomes
improved or completely pain-free (in comparison to somewhat
improved, no change, somewhat worsened or significantly worsened) At seven and 12 weeks follow-up, participants in the massage and the
were classified as recovered. Sickness absence was self-reported. Par­ combined therapy groups had lower mean pain intensity than partici­
ticipants who had missed at least half a day of work due to neck pain in pants in the advice group (Fig. 2A and B). The mean of pain related

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

Fig. 1. Flow of patients in the Stockholm Neck

Trial.
*Description of ineligible subjects in numbers: 1)
Not willing to complete the trial: 520; specific
diagnosis: 155; no neck pain: 24; pain <30 days:
25; ineligible age: 14; not fluent in Swedish: 9; no
smartphone: 2; mild symptoms: 22; previously
enrolled: 1; treatment in the past 30 days: 74;
specific training for neck pain: 7; cancer: 15; red
flags: 22; contraindication: 3.
yQuit and requested to delete all their information
from the study.

disability for combined therapy and exercise were lower than for advice 4. Discussion
after 12 weeks.
Compared to advice, those receiving combined therapy (RR ¼ 1.39; We aimed to determine the effectiveness of deep tissue massage,
95% CI: 1.08–1.81) or massage alone (RR ¼ 1.36; 95% CI: 1.04–1.77) supervised strengthening and stretching exercise therapy and a combi­
were more likely to report MCII in pain intensity at seven weeks nation of both for the management of subacute and persistent neck pain
(Table 3). At 12 weeks, those in the combined therapy group were more compared to advice to stay active. We did not find massage alone, ex­
likely than those in the advice group to reach MCII in pain intensity ercise alone nor the combination of both, more effective than advice to
(RR ¼ 1.28, 95% CI: 1.02–1.60). At 26 weeks, massage (RR ¼ 1.23; 95% stay active in the long term regarding the primary outcomes. This is also
CI: 0.97–1.56) and exercise (RR ¼ 1.31; 95% CI: 1.04–1.65) were more illustrated by the fact that the NNT (which is a rough indicator of the
likely to show MCII in pain intensity than advice. We did not find direction and magnitude of the effect) in some comparisons for the
consistent differences between groups at 52 weeks in pain intensity. primary outcomes were high or in some instances even negative. How­
We did not find consistent differences in pain related disability be­ ever, we found that massage alone or with exercises were more effective
tween the groups. regarding a clinically meaningful improvement in pain intensity than
advice to stay active in the short term, and that massage and exercise
alone were more effective in the mid term. Regarding the patient
3.2. Secondary outcomes centered secondary outcome perceived recovery, we found short and
long term effects of deep tissue massage, supervised strengthening and
The incidence of perceived recovery at 52 weeks was 20% in the stretching exercise therapy and a combination of both therapies.
advice group, 27% in the exercise group (NNT ¼ 15), 35% in the mas­ Our finding that massage alone or with exercises was effective in
sage group (NNT ¼ 7) and 40% in the combined therapy group reducing pain in the short term but not in the long term, and that
(NNT ¼ 5) (Tables 2 and 3). Compared to the advice group, those in the perceived recovery was reported more often in these groups than in the
other three interventions were more likely to report self-perceived re­ advice to stay active group in the short and long-term should not be
covery during follow-up (Table 3): at seven weeks; massage (RR ¼ 3.29; viewed as conflicting. In individuals with persistent pain, self-perceived
95% CI: 2.00–5.42); exercise (RR ¼ 1.66; 95% CI: 0.95–2.89); combined recovery might not necessarily imply resolution of pain. Rather, it may
therapy (RR ¼ 3.01; 95% CI: 1.82–4.96). At 52 weeks: massage suggest that participants have readjusted to pain (the person has learned
(RR ¼ 1.74; 95% CI: 1.13–2.67); exercise (RR ¼ 1.33; 95% CI: how to cope with pain), redefined what it means to be healthy (the
0.84–2.09); combined therapy (RR ¼ 1.99; 95% CI: 1.32–3.00) person has redefined health) or reached an acceptable quality of life for
(Table 3). The risk of having at least one day of sick absence due to neck them (Beaton et al., 2001; Hush et al., 2009). Our findings suggest that
was similar in all groups. massage, exercise or a combination of both may favour these outcomes.
There was no difference in the number of visits to additional We think that the observed effects might also be due to mechanisms
healthcare providers at 52 weeks across groups, however, 23% of the beyond the immediate effects of deep tissue stimulation and the pro­
participants in the advice group visited a masseur during the first three gressive muscle strengthening. For instance, the effect of being taken
months compared to 12, 14 and 13% in massage, exercise and combined care of and the relations of empathy that took place along repeated
therapy groups respectively. patient-therapist interaction may have had an effect in overall patient
satisfaction, anxiety and distress, facilitating patient enablement
3.3. Adverse events (Derksen et al., 2013).

No participants developed serious (life threatening, resulting in 4.1. Comparison with previous studies
hospitalizations or in a significant change of the treatment strategy)
adverse events. One person in the massage group who reported highly Exercise therapy was not more effective to reduce pain intensity or
bothersome dizziness discontinued treatment after the third session. A pain related disability than advice to stay active in the short or the long
full report on occurrence and risk of adverse events from the STONE trial term. A recent systematic review found that supervised combined ex­
will be published separately. ercises (strengthening, stretching/range of motion and flexibility) twice

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

Table 1
Baseline characteristics of the study participants by treatment group.
Massage Exercise Combined therapy Advice

n ¼ 145 n ¼ 159 n ¼ 168 n ¼ 147

Age, mean (SD) 48(14) 47(14) 45(14) 46(13)

Women 97 67% 112 70% 119 71% 98 67%
Education
12 years or less 43 30% 55 35% 65 39% 54 37%
More than 12 years 102 70% 104 65% 103 61% 93 63%
Occupation category (Statistics Sweden, 2012)
Managerial or high university degree 56 39% 61 39% 75 45% 71 48%
University degree, administration and client-oriented 41 28% 53 33% 33 20% 34 23%
Service, care, sells, construction, transportation or short education 23 16% 26 16% 33 20% 27 19%
Student/retired/other 25 17% 19 12% 25 15% 15 10%
Level of job demands (Karasek et al., 1998)
Low 34 29% 44 32% 35 26% 50 39%
Intermediate 64 56% 72 53% 80 59% 60 47%
High 17 15% 21 15% 20 15% 17 14%
Level of job control (Karasek et al., 1998)
Low 85 73% 95 68% 97 71% 97 76%
Intermediate 20 17% 27 19% 28 20% 18 14%
High 11 10% 18 13% 12 9% 13 10%
Duration of neck pain
1–3 months 20 14% 34 21% 33 20% 25 17%
4–6 months 15 10% 20 13% 27 16% 23 16%
7–12 months 18 12% 17 11% 12 7% 11 7%
12 þ months 92 64% 88 55% 96 57% 88 60%
Characteristics of pain onset
Sudden 32 22% 30 19% 35 21% 34 23%
Gradual 89 61% 115 72% 111 66% 91 62%
Unsure 24 17% 14 9% 22 13% 22 15%
Pain intensity at baseline, mean (SD) 5.9(1.3) 6.1(1.3) 6.1(1.5) 5.8(1.5)
Disability at baseline, mean (SD) 4.4(2.0) 4.2(1.8) 4.3(1.7) 4.3(1.7)
Previous episodes of NP 67 46% 74 47% 90 54% 75 51%
Ever personal trainer
No 101 70% 104 65% 115 69% 101 69%
At least once 44 30% 55 35% 43 31% 46 31%
Ever massage
No 16 11% 5 3% 8 5% 14 10%
At least once 129 89% 154 97% 160 95% 133 90%
Depressive symptoms (Zigmond and Snaith, 1983) 22 15% 22 14% 19 11% 11 7%
Ever diagnosed with depression 41 28% 44 28% 49 29% 46 32%
Use of medication
None 40 27% 32 20% 38 23% 30 20%
Paracetamol 24 16% 26 16% 27 16% 14 10%
NSAID 29 20% 36 23% 22 13% 35 24%
Paracetamol þ NSAID 27 19% 38 24% 43 26% 43 29%
Muscle relaxants, migraine medications 14 10% 14 9% 21 12% 14 10%
Opioids, SSRI, anticonvulsants 11 8% 13 8% 17 10% 11 7%
Sleep disorder 12 8% 16 10% 17 10% 13 9%
Daily smoking 8 6% 10 6% 10 6% 14 10%
Body mass index, mean (SD) 24(3) 24(4) 24(4) 24(4)
Low or normal (<25) 83 57% 98 62% 113 67% 84 575
Overweight (25–29.9) 55 38% 52 32% 36 22% 52 35%
Obese (�30) 7 5% 9 6% 19 11% 11 8%
Self-perceived health
Excellent 13 9% 6 4% 9 5% 12 8%
Very good 39 27% 54 34% 54 32% 43 29%
Good 58 40% 62 39% 69 41% 64 44%
Satisfactory or poor 35 24% 37 23% 36 22% 28 19%
Expectations on recovery, median (IQR) 3(5) 3(4) 3(4) 3(4)
0–3 78 54% 89 56% 99 59% 82 56%
4–6 39 27% 42 26% 40 24% 45 30%
7 - 10 28 19% 28 18% 29 17% 20 14%

IQR¼ Inter quartile range.

a week for 12 weeks should be considered as a treatment option but that exercises for 12 weeks showed better results in pain intensity and
supervised strengthening exercises alone twice a week for six weeks disability than a prescription of physical activity (Ludvigsson et al.,
should not (Co ^t�e et al., 2016). A trial found no differences in pain in­ 2015). Likewise, a study on participants with non-specific neck pain
tensity or disability between a comprehensive exercises program during studying strength and endurance showed better results at reducing pain
12 weeks compared to advice in patients with chronic neck pain due to intensity and disability at one year follow-up compared to a control
whiplash. However, like in our study, they found better self-perceived group of advice on stretching and aerobic exercise (Ylinen et al., 2003).
recovery among those in the comprehensive exercises program up to Discrepancies in the results might partly be due to the choice of the
12-months follow-up (Michaleff et al., 2014). In contrast, a trial (also in comparison group. Although participants in the exercise group were
participants with whiplash) comparing the effect of neck specific advised to repeat the exercises at home, we did not explore whether

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

Fig. 2. A) Mean pain intensity at baseline and follow-ups. B) Mean pain related disability at baseline and follow-up. Table 2 presents 95% confidence intervals for
changes in pain and pain-related disability over follow-up.

compliance influenced the outcomes. disability or pain intensity at follow-ups (Cheng and Huang, 2014).
A previous trial of deep tissue massage (average of eight sessions) However, it is uncertain from most of the included studies whether
suggested that its effect is short-lived compared to a booklet (Sherman participants had acute or chronic pain. In addition, the most common
et al., 2009). In our study, the effects on pain intensity were seen in the massage technique used was Chinese massage, rather than deep tissue
short term only but the effect of a deep tissue massage on perceived massage.
recovery lasted one year. A meta-analysis showed only immediate Our results are in line with a previous trial that showed that adding
beneficial effects of massage on pain intensity in comparison to inactive connective tissue massage to scapula-thoracic stabilization exercises is
controls and Chinese traditional medicine but no beneficial effect on effective for reducing night neck pain intensity after a four-week

6
E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

Table 2
Proportion of participants with the outcomes minimal clinically important change (MCII) in pain and disability, number needed to treat (NNT), mean absolute change
in pain and disability, proportion of perceived recovery and proportion of persons with sick absence.
Massage Exercise Combined therapy Advice

MCII Pain % (95% CI) NNT % (95% CI) NNT % (95% CI) NNT % (95% CI) NNT
7 weeks 53 (45–62) 8 45 (37–53) 20 55 (47–63) 7 40 (31–49) Ref
12 weeks 52 (44–61) 34 48 (40–57) 100 61 (53–69) 9 49 (40–58) Ref
26 weeks 58 (49–66) 10 62 (53–70) 7 54 (45–62) 15 47 (37–56) Ref
52 weeks 57 (48–65) 33 61 (53–70) 15 59 (51–67) 20 54 (45–64) Ref
MCII Disability
7 weeks 81 (74–87) 15 74 (66–81) 0 79 (71–85) 20 74 (65–81) Ref
12 weeks 77 (73–87) 25 74 (67–81) 15 83 (76–88) 50 81 (73–87) Ref
26 weeks 76 (68–83) 100 77 (69–84) 50 80 (73–86) 20 75 (67–83) Ref
52 weeks 78 (70–85) 100 82 (75–88) 34 84 (77–89) 20 79 (71–86) Ref
Change in Pain mean (95% CI) mean (95% CI) mean (95% CI) mean (95% CI)
7 weeks 2.1 ( 2.3 to 1.8) - 1.8 ( 2.1 to 1.5) - 2.0 ( 2.3 to 1.8) - 1.5 ( 1.8 to 1.2) -
12 weeks 2.4 ( 2.7 to 2.1) - 2.4 ( 2.7 to 2.1) - 2.6 ( 2.9 to 2.3) - 2.1 ( 2.4 to 1.8) -
26 weeks 2.3 ( 2.6 to 2.0) - 2.6 ( 2.9 to 2.3) - 2.5 ( 2.8 to 2.2) - 2.1 ( 2.4 to 1.8) -
52 weeks 2.3 ( 2.7 to 2.0) - 2.7 ( 3.0 to 2.3) - 2.5 ( 2.8 to 2.2) - 2.2 ( 2.5 to 1.9) -
Change in Disability
7 weeks 2.5 ( 2.9 to 2.2) - 2.1 ( 2.4 to 1.8) - 2.2 ( 2.5 to 1.9) - 2.1 ( 2.4 to 1.8) -
12 weeks 2.7 ( 3.1 to 2.4) - 2.5 ( 2.8 to 2.2) - 2.7 ( 3.0 to 2.4) - 2.5 ( 2.8 to 2.1) -
26 weeks 2.7 ( 3.0 to 2.3) - 2.6 ( 2.9 to 2.3) - 2.8 ( 3.1 to 2.5) - 2.6 ( 2.9 to 2.2) -
52 weeks 2.6 ( 3.0 to 2.2) - 2.7 ( 3.0 to 2.4) - 2.8 ( 3.1 to 2.5) - 2.6 ( 2.9 to 2.2) -
Perceived Recovery % (95% CI) % (95% CI) % (95% CI) % (95% CI)
7 weeks 41 (33–50) 4 22 (15–29) 12 37 (30–46) 5 13 (07–20) Ref
12 weeks 37 (29–46) 5 27 (20–35) 10 33 (26–41) 7 17 (11–25) Ref
26 weeks 35 (27–44) 6 31 (24–40) 8 38 (30–46) 5 18 (11–26) Ref
52 weeks 35 (27–43) 7 27 (20–35) 15 40 (32–48) 5 20 (13–28) Ref
Sick Absence (at least one day)
Baseline 29 (21–38) - 31 (23–39) - 31 (23–39) - 23 (16–32) -
7 weeks - - - - - - - -
12 weeks 13 (07–20) 50 15 (10–23) 0 18 (12–25) 34 15 (09–24) Ref
26 weeks 13 (07–20) 25 14 (09–22) 20 18 (12–25) 12 9 (04–15) Ref
52 weeks 21 (14–29) 34 20 (13–28) 50 21 (15–29) 34 18 (11–27) Ref

NNT: Number needed to treat compared to advice to stay active.

4.2. Strengths and limitations

Table 3
Relative risk (RR) and 95% Confidence Intervals (95%CI) of having the primary
Our study has several strengths. First, our trial is, to our knowledge,
and secondary outcomes over one year follow-up in the index groups compared
the largest ever conducted on the effectiveness of massage for the
to the advice group.
treatment for subacute and persistent neck pain. Our sample size
Massage Exercise Combined therapy
allowed effective randomization. Second, our study measured outcomes
RR 95% CI RR 95% CI RR 95% CI at multiple time points allowing for a thorough description of the
PRIMARY OUTCOMES treatment effectiveness over time. Third, the risk of outcome misclas­
Minimal clinical important improvement of pain sification is low because our measurement methods were valid (Von
7 weeks 1.36 1.04–1.77 1.14 0.86–1.51 1.39 1.08–1.81 Korff et al., 1992). Fourth, we achieved a high follow-up rate and
12 weeks 1.09 0.85–1.39 1.00 0.78–1.29 1.28 1.02–1.60
confirmed that there were no systematic differences in baseline char­
26 weeks 1.23 0.97–1.56 1.31 1.04–1.65 1.15 0.90–1.46
52 weeks 1.03 0.83–1.29 1.11 0.90–1.37 1.10 0.89–1.35 acteristics between those who dropped out and those who completed the
Minimal clinical important improvement of pain-related disability trial. Finally, we adopted a pragmatic approach to the design and de­
7 weeks 1.11 0.97–1.27 1.00 0.86–1.15 1.08 0.95–1.23 livery of care to provide interventions that are similar to regular clinical
12 weeks 0.96 0.85–1.10 0.94 0.83–1.07 1.04 0.93–1.17 practice.
26 weeks 1.02 0.89–1.18 1.03 0.90–1.18 1.08 0.94–1.23
52 weeks 0.98 0.86–1.11 1.03 0.92–1.17 1.06 0.94–1.19
Our trial has limitations. First, blinding was not possible due to the
SECONDARY OUTCOMES characteristics of the interventions, and therefore expectations of re­
Perceived recovery covery may differ between the treatment arms and probably explain to
7 weeks 3.29 2.00–5.42 1.66 0.95–2.89 3.01 1.82–4.96 some extent the differences in results between the interventions. Second,
12 weeks 2.27 1.44–3.57 1.61 1.00–2.61 2.01 1.27–3.18
the advice group received a maximum of three sessions of therapy
26 weeks 1.98 1.27–3.09 1.74 1.10–2.74 2.12 1.38–3.27
52 weeks 1.74 1.13–2.67 1.33 0.84–2.09 1.99 1.32–3.00 compared to six in the other groups. The number of advice sessions
Sick absencea (three) were considered adequate to achieve the purpose of the inter­
7 weeks - - - - - - vention. It is possible that the less frequent patient-therapist interaction
12 weeks 0.85 0.46–1.58 1.04 0.59–1.84 1.14 0.65–1.97 in the advice group impacted on the results. Third, despite using
26 weeks 1.37 0.64–2.95 1.71 0.83–3.51 1.98 0.99–3.96
52 weeks 1.08 0.65–1.81 1.07 0.64–1.78 1.03 0.62–1.70
balanced block randomization to minimize differences in the number of
individuals between the groups, the number of participants differed
a
Information on sick absence was not collected in the 7 weeks questionnaire. across the groups due to the two-stage procedure used to include par­
ticipants. Even though the power calculation indicated that 600 par­
program, as well as for mental health and pressure pain threshold ticipants was sufficient for the primary research question, we had to
(Celenay et al., 2016). Thus, supporting the recommendation that account for potential loss of participants between assessment by the
massage plus supervised exercises are beneficial and could be consid­ study coordinator (baseline questionnaire A) and, the second assessment
ered among persons with grade I-II NP (Guzman et al., 2008). by the therapist in the first visit to the research clinic (baseline ques­
tionnaire B) and inclusion in the trial. We therefore prepared an

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

allocation sequence of 800. Since 621 participants were enrolled, we rather than comparing all therapies against each other. Nevertheless, the
only used 621 envelopes. The treatment groups were unequal by chance. design gives a unique opportunity to study if combining treatments
However, this is probably not a threat to the internal validity of the trial provide more benefits than the interventions on their own. Even though
because our analyses showed no differences between the groups the statistical power was too low for such comparisons, the results
regarding the baseline characteristics. Further, there is a risk for selec­ indicate that there are no clear differences in effect between combined
tion bias due to attrition since those who dropped out were more often and single treatments in this trial.
those in the advice group. However, we did not observe differences in Our findings suggest that a short course of deep tissue massage alone
terms of baseline characteristics between them and those who or in combination with strengthening and stretching exercises could be a
completed the trial in that group. We do not have information on the treatment option for persons with subacute and persistent neck pain.
reasons for dropping out, but if those dropping out did not recover, we Adding strengthening and stretching exercises to massage may help in
might have underestimated the effect of massage and/or exercise. On maintaining the effect over time. Clinicians and patients should not
the other hand, if the reason for dropping out was full recovery, we expect a higher decrease in levels of pain intensity or disability by using
might have instead, overestimated the effects of the mentioned these therapies instead of advice to stay active, but rather an improve­
therapies. ment in other dimensions of the condition, better measured by perceived
It might have been difficult for participants to recall with precision recovery.
the number of days off work due to neck pain or how they perceived
their neck pain (the secondary outcomes sickness absence and self- 5. Conclusions
perceived recovery). However, we have no reasons to believe that this
occurred differentially between the treatment arms. In this study, the results at 12-monts follow-up were that none of the
All 30 therapists provided all the four treatment arms. It is possible index therapies; deep tissue massage, supervised strengthening and
that despite our efforts for standardizing the procedures, some therapists stretching exercises, or a combined therapy; were more effective than
might have personal preferences for one treatment modality and might advice to stay active in terms of clinically important change in pain
have put more effort in providing that specific one instead of the others. intensity or pain-related disability. However, the index therapies led to
We did efforts to minimize that risk by preparing a standardized training higher incidence of clinically important improvement in pain intensity
in the delivery of all four interventions and, by having regular meetings in the short term and to higher incidence of favorable perceived re­
and emphasizing the importance of following the procedures. Despite covery in the short and in the long term than advice to stay active.
the fact there was variation in the degree of expertise in the provision of Clinicians may consider recommending these modalities as treatments
the interventions between the therapists (some of them were students), for persons with subacute or persistent neck pain.
we think that such variation was distributed evenly between the inter­
vention groups and has little or no effect on the results. Ethical approval
We adapted the Chronic Pain Grade Questionnaire and used the
means of pain intensity and pain-related disability, rather than the usual The trial was approved by the Regional Ethic Committee in Stock­
staging system. Although this modified version has not been validated, a holm (Dnr: 2014/755-31/3).
panel of experts agreed on the appropriateness of using this modified
instrument for the assessment of neck pain the past four weeks, instead Funding/support
of the past six months, as well as the use of a mean value for pain in­
tensity and a mean value for pain-related disability. This modified Swedish Research Council (VR) 52120133739, Swedish Research
approach has been used repeatedly in previous publications (Von Korff Council for Health, Working Life and Welfare (FORTE) 20141483 and
et al., 1992; Smith et al., 1997; Paanalahti et al., 2016; Skillgate et al., The Swedish Naprapathic Association funded this study.
2007).
Although we aimed to minimize contamination by asking partici­
Additional contributions
pants to avoid other treatments in the first three months post-
randomization, participants in the advice group used additional health
Authors extend special thanks to Anna Peterson, for the coordination
services to a larger extent during the first three months (they spent on
of the data collection, data cleaning and valuable input along the con­
average 290 Euros, compared to 207–220 Euros in the other groups, p-
duction of the study and interpretation of the data; and to Fredrik
value < 0.001) which we believe may have underestimated the differ­
Johansson and Martin Asker for their orientation during the design and
ence in early effect between advice and the other interventions.
implementation of the interventions.
This is a multi-arm controlled trial, designed to improve the effi­
ciency of the evaluation of the interventions. However, there is an
Data sharing
increased probability of type I error (false positive results) due to mul­
tiple testing. Although a statistical correction would have shown more
The STONE data is confidential and is not publicly available.
conservative results, we did not perform such correction, considering
that the different arms corresponded to different treatment modalities,
rather than different doses of the same therapy (Wason et al., 2014). Declaration of competing interest
As stated in the study protocol, we aimed to study whether the
therapies in question were at least as effective as advice to stay active, Nothing to declare.

Appendix B. Supplementary data

Supplementary data to this article can be found online at https://doi.org/10.1016/j.msksp.2019.102070.

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

Appendix A. Description of the interventions in the STONE trial

1. Massage

Effleurage technique of the whole back and neck was followed by petrissage, kneading and edging/scissoring. Additionally, dynamic stretching as
a component of fascial release technique could be offered as part of the treatment. Additionally, thorax and/or jaw musculature was treated if
indicated.
A maximum of six sessions of therapies during six weeks were recommended: twice a week the first week and less often thereafter. The visits lasted
45 min and at least 35 min were dedicated to active treatment at every session. After general treatment of neck and back, the therapist focused on the
most affected/sored ones. The pressure during the massage was adjusted according to the patient’s status/willingness. The massage should be
experienced properly and beneficial without reaching more than 5/10 in a visual analogue scale in pain and the participant got the information that
they could ask for adjustments in the intensity of the massage at any given time. Good communication with the patient was encouraged.
Pressure was applied with a focus on the area that produced concordant signs. Pressure on such areas was repeated with three increments of
pressure applied at every decrease of the pain; if there was no decrease in pain, the pressure was sustained for 30 s. Fascial techniques with and without
active movement participation were combined with the techniques described above.
2. Exercise Training

A maximum of six sessions of therapies during six weeks were recommended: twice a week the first week and less often thereafter. The visit lasted
45 min and at least 35 min dedicated to active treatment at every session.
The program focused on activation of muscles of the neck area. The patient worked out all muscles/exercises, but the exercises were adjusted
depending on the patient status/tolerance and ability to perform, one out of three levels of intensity was chosen based on two aspects. This evaluation
(points 1 and 2) was also the base to decide whether the participant could progress to the next intensity level in the exercises.

1. The patient performance:

The participant should perform the exercise correctly with minimal co-activation of other muscles/movements.
Strain: the aim was that the participant performed the specified exercises in 3 � 10 repetitions if no other instruction was given.

2. Pain experienced by the patient:

The exercises should not produce pain over 5/10 in a visual analogue scale and the neck pain should not increase the next day after training with
more than 2 points in the same scale.
The participant was instructed to perform the exercises at home one to two times per week doing 3 � 10 with good technique. For this purpose, the
participant was filmed with their smartphone, as support for the exercises and the therapist indicated what was important to consider during the
execution of the exercises with verbal instructions.
Specific description of the exercises:

1 Activation of deep neck flexors (“The owl”)

� Purpose: to activate and strengthen deep cervical flexors (M. longus colli and M. rectus capitis anterior) for increased cervical strength and/or
neck function.
� Considerations: minimize pressure of extensors, avoid compensation of global musculature and observe that breathing is maintained normally.
�Level of intensity 1–3 � 10 repetitions.
In supine position, slowly retract the shin against neck and go back to the start position. Repeat.
�Level of intensity 2–3 � 30 s.
In sitting or standing position, slowly retract the shin against neck, hold with light pressure against the forehead and go back to the start
position.
�Level of intensity 3–3 � Max seconds.
In supine position, slowly retract the shin against the neck, lift the head 1 cm above the bench maintaining the shin retracted.
2 Training of chest musculature (Pushups plus).
� Purpose: to strengthen chest musculature and muscles around the scapula.
� Considerations: Minimize cervical and lumbar hyperlordosis and avoid elevation of scapula. Do a pushup with straight body, push the arms
forwards once the up position is reached so that the scapula separates. Repeat.
�Level of intensity 1–3 � 10 repetitions against the wall or a bench
�Level of intensity 2–3 � 10 repetitions against the floor on the knees.
�Level of intensity 3–3 � 10 repetitions against the floor on the toes.
3 Training of scapula musculature (Lying pulldown)
� Purpose: to strengthen muscles around shoulders (M. serratus anterior, M. Trapezius pars ascendens) with simultaneous static control of the
cervical musculature.
� Considerations: minimize cervical and lumbar hyperlordosis and avoid elevation of shoulders.
� In supine position retract the shin against the neck, lift the head 1 cm above the bench while maintaining the shin in the same position and hold.
Drag the arms along the body (resembling a change from a “Y”-position to a “W”-position) and finish with contraction between the scapula.
Repeat.
�Level of intensity 1–3 � 10 repetitions without rubber band.
�Level of intensity 2–3 � 10 repetitions with rubber band 1.
�Level of intensity 3–3 � 10 repetitions with rubber band 2.
4 Training of deep extensors of the neck

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E. Skillgate et al. Musculoskeletal Science and Practice 45 (2020) 102070

� Purpose: to strengthen deep extensors of the neck (Mm. Erector spinae).

� Considerations: high extension of the neck and compensation of global musculature.
�Level of intensity 1–3 � 1 min.
In prone position, drag the shin against the neck, lift the head 1 cm above the bench while maintaining the same position and hold.
�Level of intensity 2–3 � 1 min.
In prone position, hold the arms along the body, rotate the arms in and out with contraction of the area between scapula.
�Level of intensity 3–3 � 1 min.
In prone position, abduct and adduct the shoulder joint.
5 Training of the scapula musculature (scapulothoracic control exercise)
� Purpose: to strengthen muscles around shoulders (M. Trapezius pars descendens). Alternative to patients with high levels of pain.
� Considerations: avoid elevation of scapula.
�Level of intensity 1–3 � 10 repetitions
Standing/Sitting hold the hands behind the back, drag the shoulders back and downwards while contracting the area between scapulae.
Repeat.
�Level of intensity 2–3 � 1 min.
Lying on one side, flex and extend the free arm while maintaining the position of the scapulae.
�Level of intensity 3–3 � 1 min.
In prone position, let the head to rest, resemble a diamond shape with the arms and lift the hands by contracting the area between the
scapulae.
6 Stretching of chest muscles
� Purpose: to decrease the tonus of the chest musculature (M. Pectoralis major).
� 15–20 s, 3 times each side. With flexed elbows against a wall, stretch out the chest musculature by rotating the body away from the arms.

7 Stretching – depressors of the shoulder.

� Purpose: decrease the tonus in the depressors of the shoulder (M. Pectoralis minor).
� 15–20 s, 3 times each side. In standing or supine position, elevate the shoulder and arm, rotate the body towards the opposite side and hold
with flexed knees (if supine position).
8 Stretching – jaw musculature
� Purpose: decrease the tonus in the jaw musculature (M. masseter, M. temporalis, Mm. pterygoidei).
� 15–20 s � 3 times. Open the jaw wide. Thereafter, strain the mouth by pressing the fingers against the upper and lower teeth.
9 Stretching – jaw musculature (Interoceptive neuromuscular facilitation)
� Purpose: decrease the tonus in the jaw musculature (M. masseter, M. temporalis, Mm. pterygoidei).
� 3 � 10 repetitions. Place a fist under the shin. Open the jaw slowly with a light resistance with the fist. Hold for 6 s. Repeat.
10 Stretching – jaw musculature (Proprioceptive neuromuscular facilitation)
� Purpose: decrease the tonus in the jaw musculature (M. masseter, M. temporalis, Mm. pterygoidei).
� 3 � 10 repetitions. Open the jaw, and try to close it while resisting the movement by dragging the lower portion of the jaw with the fingers
placed on the lower teeth row.

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3. Massage And Training

A maximum of six sessions of therapies during six weeks were recommended. The visit lasted 60 min and at least 25 min were dedicated to active
treatment with strengthening and stretching exercises, followed by at least 25 min of deep tissue massage, both as described above.
4. Advice

A maximum of three visits were offered. Evidence-based advice was given based on scientific statements from SBU (Statens beredning fo€r med­
icinsk och social utv€ardering: Swedish agency for health technology assessment and assessment of social services) (SBU, 2000) and Cochrane (Kar­
jalainen et al., 2003; Gross et al., 2015a, 2015b; Patel et al., 2013) consisting of the following elements:

� Adequate information on the condition and reassurance to the participant that the condition is not dangerous but a tolerable strain and that the
most important according to previous experience and research is to try to self-control their own pain by being active both socially and physically.
� Advice to the participant to be active and continue daily activities including work, if possible.
� Description of over the counter medications that could be used, if necessary, to relieve pain, mentioning that it is common to take regularly, in a
first stage, paracetamol, and then NSAIDs (observing that there are contraindications and risk factors).
� Revision of which movements can be relevant according to standard recommendations (Can use the online resource Exor-Live (ExorLive, 2019) for
maximum three exercises) observing that this should not be as detailed and adjusted as the interventions in the exercise group.

Participants were classified in three different groups:

1. Those who did not have physical activity as a habit (whom were instructed on minimal exercises mainly oriented towards good circulation).
2. Those who had physical activity as a habit (adjustments were suggested to incorporate exercises to the training habit).
3. Those who were highly active (adjustments of the exercises to the training habit were suggested with focus on neck musculature).

Finally, a booklet was given with the different approaches to manage back and neck pain and information facts about exercises.

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