PTJ 1275
PTJ 1275
PTJ 1275
Results. The exercise intervention improved activity and patient’s global impres- R.D. Herbert, PT, PhD, is Senior
sion of recovery but did not clearly reduce pain at 2 months. The mean effect of Research Fellow, Musculoskeletal
Division, The George Institute for
exercise on activity (measured by the Patient-Specific Functional Scale) was 1.1
International Health, and Associ-
points (95% confidence interval [CI]⫽0.3 to 1.8), the mean effect on global impres- ate Professor, Sydney Medical
sion of recovery was 1.5 points (95% CI⫽0.4 to 2.5), and the mean effect on pain was School, The University of Sydney.
0.9 points (95% CI⫽⫺0.01 to 1.8), all measured on 11-point scales. Secondary
Author information continues on
outcomes also favored motor control exercise. next page.
L
K.M. Refshauge, DipPhty, Grad ow back pain is a major health challenged in dynamic tasks.17,18
DipManipTher, MBiomedE, PhD, is Director, and socioeconomic problem and Morphologically, a lower cross-
Research & Innovation, and Deputy Dean,
is associated with high costs in sectional area19 and a larger percent-
Faculty of Health Sciences, The University of
Sydney, Sydney, Australia. care, work absenteeism, and disabil- age of intramuscular fat in the multi-
ity worldwide.1–3 A recent inception fidus muscle20 were found in
J.H. McAuley, PhD, is Research Manager,
cohort study demonstrated that 43% patients with low back pain com-
Musculoskeletal Division, The George Insti-
tute for International Health. of patients with acute low back pain pared with asymptomatic controls.
seen in primary care settings devel- Moreover, it was found that patients
M.D. Jennings, PT (Hons), is Deputy Direc-
oped chronic low back pain and that with low back pain tend to increase
tor, Physiotherapy Department, Liverpool
Hospital, Sydney South West and Western nearly a third of them did not re- the spinal stiffness to compensate for
Sydney Area Health Services, Sydney, cover within 1 year.4 the lack of stability from the deep
Australia. muscles by increasing the activity of
placebo-controlled trials were identi- cated to treatment groups by the muscles (including transversus ab-
fied. In order to establish the efficacy physical therapist who opened the dominis and multifidus) and reduce
of motor control exercise for next-numbered envelope. overactivity of specific superficial
chronic low back pain, we con- muscles in an individualized
ducted the first placebo-controlled Participants in each group received manner.
trial of this intervention. 12 half-hour treatments over an • Stage 2. Implement precision of the
8-week period (2 sessions per week desired coordination and train
Method in the first month and 1 session per these skills in static tasks and incor-
Setting and Participants week in the second month). The pla- porate them into dynamic tasks and
This randomized, placebo-controlled cebo treatment was designed to be functional positions.
trial was conducted in an outpatient structurally equivalent26 to the active
physical therapy department of a intervention, providing similar con- Stage 1 of the exercise program in-
discharge session in which the pa- ments would not unblind partici- Baseline data were collected prior to
tient’s progress was reviewed and pants. The sham machines were randomization. The baseline data in-
exercises were prescribed to be con- identical to active machines (eg, the cluded all outcome measurements
tinued at home. A more comprehen- on and off lights illuminated, the out- and the participant’s characteristics
sive description of the motor control put dial moved), except that they did (age, sex, ethnicity, religion, weight,
intervention is presented online at not provide output. The nature of height, level of education, and em-
www.ptjournal.org. the interventions precluded blinding ployment status). In addition, we col-
of the treatment provider. lected information about depressive
The placebo intervention consisted symptoms (measured with the De-
of 20 minutes of detuned shortwave Outcomes and Follow-up pression Anxiety Stress Scales [DASS-
diathermy and 5 minutes of detuned Measurements of outcomes were ob- 21])39,40 to test whether the effect of
ultrasound for 12 sessions over an tained at baseline and at follow-up the exercise intervention on primary
Table 1.
Outcome Measures
Roland-Morris Disability Questionnaire (RMDQ)57 Activity limitation The RMDQ is a 24-item questionnaire related to normal activities of
daily living. Patients are asked to tick the items that they perceive
as difficult to perform due to low back pain. Each answer is scaled
either 0 (no difficulty) or 1 (difficulty), thus leaving a range of
scores from 0 to 24, with a higher score indicating higher levels of
activity limitation. This well-known questionnaire has proven to be
reliable,58 valid,59 and responsive35 in patients with low back pain.
Patient-Specific Functional Scale (PSFS)34 Activity In the PSFS, patients are asked to identify up to 3 important activities
that they are having difficulties with or are unable to perform due
to their condition (eg, low back pain). In addition, the patients are
Pain numerical rating scale (NRS)60 Pain intensity The pain NRS involves asking patients to rate their pain intensity
levels over the previous week on an 11-point scale (ranging from 0
[“no pain”] to 10 [“pain as bad as could be”]). The number that
the patient states represents his or her pain intensity score. This
scale has good measurement properties.59
Global Perceived Effect Scale (GPE)61 Overall measure The GPE is an 11-point scale that ranges from ⫺5 (“vastly worse”) to
of change 0 (“no change”) to ⫹5 (“completely recovered”). For all measures
of global perceived effect (at baseline and all follow-ups),
participants were asked, “Compared to when this episode first
started, how would you describe your back these days?” A higher
score indicates greater recovery from the condition. This scale has
good measurement properties.62
unit on the GPE (estimated SD⫽1.7), treatment ⫻ time interactions pro- was tested in a post-hoc analysis and,
and 4 units on the RMDQ (estimated vided estimates of the effects of the therefore, was considered as second-
SD⫽4.9) when the alpha level is set exercise intervention. ary. We calculated confidence inter-
at .05. vals (CIs) for the risk difference us-
To determine whether baseline de- ing the method described by
Data were double-entered. The sta- pression scores modified the effect Newcombe based on Wilson’s score
tistical analysis was performed on an of exercise, a secondary analysis was method, without continuity
intention-to-treat basis. The statisti- conducted in which a higher-level correction.46
cian was given coded data and thus interaction term (baseline DASS-21
was blinded to which group re- depression score ⫻ group ⫻ time) Mixed-models analyses were per-
ceived the exercise intervention. was added to each of the regression formed with Stata 9.* Other analyses
models.45 were performed with SPSS version
The mean effects of intervention on 16.0 for Windows.†
pain intensity, activity (measured by As very few patients recovered, ac-
the PSFS and RDMQ), and global im- cording to our definition of being Role of Funding Sources
pression of recovery were calculated pain-free for 30 days during the study The study was funded by a Research
using linear mixed models (random period, only a small subset of partic- & Development grant from The Uni-
intercepts and fixed coefficients), ipants could experience a recur- versity of Sydney and the Physiother-
which incorporated terms for treat- rence. To provide a measure relevant apy Research Foundation–Australian
ment, time, and the treatment ⫻ to all participants, we created a new Physiotherapy Association. The
time interactions. The effect of time outcome called “persistent or recur- funding sources had no role in study
was nonlinear, so time was dummy rent pain,” which was coded as “no”
coded and analyzed as a categorical for participants who recovered and
variable (ie, 3 dummy variables were did not have a recurrent episode * StataCorp LP, 4905 Lakeway Dr, College Sta-
tion, TX 77845.
created for the categories 2, 6, and within 12 months and “yes” for all †
SPSS Inc, 233 S Wacker Dr, Chicago, IL
12 months). The coefficients of the other participants. This outcome 60606.
design, data collection, data analysis, tober 2005 and December 2007 sions due to distance (n⫽1), and ad-
interpretation of data, or writing of (Fig. 1). Seventeen patients chose vice from the trial therapists that the
the trial report. The investigators had not to participate, and 49 patients patient was not suitable for motor
final responsibility in the decision to were considered ineligible. The rea- control exercise treatment due to co-
submit the report for publication. sons for ineligibility were nerve root morbidities (n⫽5) (for reasons of bi-
The study was prospectively regis- compromise (n⫽9), previous spinal lateral knee replacement, substance
tered with the Australian Clinical Tri- surgery (n⫽8), serious spinal pathol- abuse, recent epilepsy collapse, vas-
als Registry (ACTRN01260500026- ogy (n⫽6), non-English speaker cular claudication, or Erdheim-
2606), and the protocol was (n⫽6), scheduled for major treat- Chester disease). Results of the sim-
published.24 ment or surgery during the follow-up ple trunk muscle task indicated that
period (n⫽5), low back pain of less motor control exercise was suitable
Results than 12 weeks’ duration (n⫽7), aged for all tested individuals, and thus no
In total, 220 participants seeking older than 80 years (n⫽1), contrain- participants were excluded based
care for low back pain were dication to exercise (n⫽1), unable to upon this criterion. Of the 154 par-
screened for eligibility between Oc- commit to attend the treatment ses- ticipants who were randomly as-
Table 2.
Baseline Characteristics
Low back pain duration (wk), mean (SD) 334.8 (392.3) 328.2 (395.1)
Education, n (%)
Table 3.
Credibility and Treatment Evaluation Comparisons
How confident would you be in recommending this treatment to a friend who 5 (2) 4 (3)
suffered from similar complaints?b
signed to groups, 152 attended the fects were temporary exacerbations the placebo group recovered but
2-month follow-up (98.7%) and 145 of pain. None of the patients with- then experienced a recurrence
attended both 6- and 12-month drew from the trial due to adverse within 12 months. Consequently,
follow-ups (94.2%). No differences effects. Ten patients from the exer- 88% of the exercise group and 98%
were detected between the partici- cise group and 14 patients from the of the placebo group were catego-
pants who were lost to follow-up placebo group reported use of coint- rized at 12 months as having persis-
and the patients who were followed erventions during the study period. tent or recurrent pain (absolute risk
up. The characteristics of the partic- reduction⫽10%, 95% CI⫽1% to 19%,
ipants in the 2 groups were similar at The exercise intervention improved number needed to treat⫽10).
baseline (Tab. 2). activity and the patient’s global im-
pressions of recovery (Tab. 4 and Exercise improved activity limitation
Out of 12 planned treatment ses- Fig. 2). At 2 months, exercise im- (measured by the RMDQ) at 2
sions, the participants in the exer- proved activity by a mean of 1.1 months (⫺2.7 points, 95% CI⫽⫺4.4
cise group attended a mean of 8.8 points (95% CI⫽1.8 to 0.3) on the to ⫺0.9) and 6 months (⫺2.2 points,
sessions (SD⫽3.5) compared with PSFS and improved patient’s global 95% CI⫽⫺4.0 to ⫺0.5), but the dif-
9.6 sessions (SD⫽3.0) for patients impression of recovery by 1.5 points ferences were smaller and no longer
allocated to the placebo group. Most (95% CI⫽2.5 to 0.4). There was not significant at 12 months (differ-
of the participants believed that they a clear effect of exercise on pain in- ence⫽1.0 point, 95% CI⫽⫺2.8 to
were allocated to a “real or active” tensity at 2 months (⫺0.9 points, 0.8). Finally, there was no evidence
intervention (85% of patients from 95% CI⫽⫺1.8 to 0.0, P⫽.053) or 6 that depression was a predictor of
the exercise group versus 84% of pa- months (⫺0.5 points, 95% CI⫽⫺1.4 response to treatment at 2 months
tients from the placebo group). The to 0.5, P⫽.335), but there was a sta- for pain intensity (⫽⫺.03, 95%
ratings of treatment satisfaction were tistically significant effect at 12 CI⫽⫺0.10 to 0.04), global impres-
similar in both groups, with the me- months (⫺1.0 point, 95% CI⫽⫺1.9 sion of recovery (⫽⫺.05, 95%
dians ranging from 4 to 6 points (on to ⫺0.1, P⫽.030) in favor of the ex- CI⫽⫺0.23 to 0.13), or activity
a 0 – 6 scale) (Tab. 3). ercise group. During the study pe- (⫽.10, 95% CI⫽⫺0.07 to 0.27).
riod, few patients had become pain-
Five patients (2 from the placebo free (recovered): 22% of the patients Discussion
group and 3 from the exercise in the exercise group and 9% in the This is the first randomized, placebo-
group) reported mild adverse effects placebo group recovered. Ten per- controlled trial of motor control ex-
of the interventions. All adverse ef- cent of the exercise group and 7% of ercise for chronic low back pain. We
work22 provides a rationale for why propriate training would be able to The main limitation of our study was
those in the exercise group, who re- perform this intervention similarly. that the trial therapists were not
trained the deep trunk muscles, ex- blinded to the treatment allocation.
perienced less resistant or recurrent Although systematic reviews of the We are unaware of a method to blind
pain than those in the placebo efficacy of exercise for chronic low therapists in trials of exercise. We
group, who had no such training. back pain5 have generally concluded tried to minimize the effect of un-
that exercise is effective, most re- blinding by training the trial thera-
This study was performed in an out- views also signal some uncertainty in pists to provide a credible placebo
patient physical therapy department their conclusions because of meth- treatment and by auditing placebo
of a public hospital, and the results odological concerns in the available treatment sessions. We believe that
of this study should be generalizable trials. Our trial avoided the main these steps were effective because
to groups of patients with similar methodological problems of previ- scores on credibility and treatment
characteristics (ie, patients with ous trials by using a placebo control satisfaction were similar in both
chronic low back pain for a long and blinding patients and assessors. treatment groups. Nevertheless, we
time, seeking care for their low back In addition, the trial was prospec- cannot exclude the possibility that
pain problems, with moderate levels tively registered and the trial proto- the lack of therapist blinding intro-
of depression and not working). In col was published.24 Lastly, we took duced some degree of bias into our
terms of the intervention, we believe steps to ensure treatment quality by results. Another potential limitation
that the motor control exercise inter- using experienced clinicians who of this study was that we were not
vention implemented in our study were trained to deliver the treat- able to monitor adherence to the
was well defined (as described in the ments according to the protocol, and home exercise program for the pa-
Data Supplement), and we are confi- we monitored treatment delivery. tients allocated to the motor control
dent that physical therapists with ap- exercise intervention.
Although it could be argued that our tional liaisons and clerical support. Dr Ma- 8 Moseley L. Combined physiotherapy and
her, Dr Latimer, Dr Herbert, Dr Refshauge, education is efficacious for chronic low
choice of placebo was not perfect, back pain. Aust J Physiother. 2002;48:
and Mr Jennings provided consultation
we believe that this choice was the 297–302.
(including review of manuscript before
best possible. We do not know of a submission).
9 Risch SV, Norvell NK, Pollock ML, et al.
Lumbar strengthening in chronic low-
“placebo exercise” that is both cred- back-pain patients: physiological and psy-
The study protocol was approved by The
ible and inert. This problem is not chological benefits. Spine. 1993;18:
University of Sydney Human Research Ethics 232–238.
unique to the study of exercise, and Committee. 10 Kuukkanen T, Mälkiä E, Kautiainen H,
similar problems with developing an et al. Effectiveness of a home exercise pro-
This study was funded by a Research & De-
appropriate placebo were found in gramme in low back pain: a randomized
velopment grant from The University of Syd- five-year follow-up study. Physiother Res
trials of complex nonpharmaceutical ney and by the Physiotherapy Research Int. 2007;12:213–224.
interventions such as spinal manipu- Foundation–Australian Physiotherapy Associ- 11 Schulz KF, Chalmers I, Hayes RJ, et al.
lative therapy32,55 and acupunc- ation. Dr Costa had his PhD supported by Empirical-evidence of bias - dimensions of
23 Ferreira PH. Effectiveness of Specific Sta- 36 Roland M, Morris R. A study of natural 50 Hodges PW. Transversus abdominis: a dif-
bilisation Exercises for Chronic Low history of back pain, part 1: development ferent view of the elephant. Br J Sports
Back Pain [PhD thesis]. Sydney, New of a reliable and sensitive measure of dis- Med. 2008;42:941–944.
South Wales, Australia: School of Physio- ability in low back pain. Spine. 1983;8: 51 Tsao H, Hodges PW. Specific abdominal
therapy, The University of Sydney; 2004. 145–150. retraining alters motor coordination in
24 Maher CG, Latimer J, Hodges PW, et al. 37 de Vet HCW, Heymans MW, Dunn KM, people with persistent low back pain. Pre-
The effect of motor control exercises ver- et al. Episodes of low back pain: a pro- sented at: 11th World Congress on Pain of
sus placebo in patients with chronic low posal for uniform definitions to be used in the International Association for the Study
back pain. BMC Musculoskelet Disord. research. Spine. 2002;27:2409 –2416. of Pain; August 21–26, 2005; Sydney, New
2005;6:1– 8. South Wales, Australia.
38 Stanton TR, Henschke N, Maher CG, et al.
25 American College of Sports Medicine. AC- After an episode of acute low back pain, 52 Tsao H, Hodges PW. Immediate changes in
SM’s Guidelines for Exercise Testing and recurrence is unpredictable and not as feedforward postural adjustments follow-
Prescription. 5th ed. Baltimore, MD: Wil- common as previously thought. Spine. ing voluntary motor training. Exp Brain
liams & Wilkins; 1995. 2008;33:2923–2928. Res. 2007;181:537–546.
26 Machado LAC, Kamper SJ, Herbert RD, 39 Henry JD, Crawford JR. The short-form 53 Hodges PW, Moseley GL. Pain and motor
et al. Imperfect placebos are common in version of the Depression Anxiety Stress control of the lumbopelvic region: effect