Heliyon 10 (2024) e24229

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Heliyon
journal homepage: www.cell.com/heliyon

Research article

Small needle-knife versus extracorporeal shock wave therapy for

the treatment of plantar fasciitis: A systematic review and
meta-analysis
Chaoqun Feng a, 1, Junjie Yao b, 1, Yizhou Xie a, Min Zhao c, Youpeng Hu a, Ziang Hu d,
Ruoyan Li a, Haoyang Wu a, Yuanxin Ge a, Fei Yang a, **, Xiaohong Fan a, *
a
Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, PR China
b
College of Acupuncture and Tuina, Changchun University of Chinese Medicine, Changchun, Jilin 130117, PR China
c
Acupuncture School, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610097, PR China
d
The TCM Hospital of Longquanyi District, Chengdu, 610100, PR China

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

Keywords: Background: Plantar fasciitis (PF) is the most common cause of chronic heel pain among adults.
Extracorporeal shock wave Extracorporeal shock wave therapy (ESWT) is the recommended in the current guidelines, and the
Plantar fasciitis small needle-knife yields acceptable clinical effects for musculoskeletal pain.
Small needle-knife
Objective: To systematically compare the efficacy of the small needle-knife versus ESWT for the
Systematic review
Meta-analysis
treatment of PF.
Methods: The present review was registered in the International Prospective Register of System­
atic Reviews (i.e., “PROSPERO”, CRD42023448813). Two of the authors searched electronic
databases for randomized controlled trials (RCTs) comparing the small needle-knife versus ESWT
for the treatment of PF, and collected outcomes including curative effect, pain intensity, and
function. Risk of bias was assessed using the Cochrane Handbook Risk of Bias tool and the quality
of the RCTs was evaluated according to the Jadad Scale. The same authors independently per­
formed data extraction from the included studies, which were imported into Review Manager
version 5.4.1(Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2020) for meta-
analysis.
Results: The initial literature search retrieved 886 studies, of which 6 were eventually included in
this study. Meta-analysis revealed no significant difference in curative effect (OR = 1.87; 95 % CI
[0.80, 4.37], p = .15) nor short-term pain improvement (MD = 2.20; 95 % CI [-2.77, 7.16], p =
.39) between the small needle-knife and ESWT. However, the small needle-knife may be more
effective than ESWT for pain improvement in mid-term (MD = 9.11; 95 % CI [5.08, 13.15], p＜
.00001) and long-term follow-ups (MD = 10.71; 95 % CI [2.18, 19.25], p＜ .00001). Subgroup
analysis revealed that the small needle-knife combined with a corticosteroid injection yielded a
statistically significant difference in reduction of pain intensity at all follow-ups (MD = 4.84; 95 %
CI [1.33, 8.36], p = .007; MD = 10.99; 95 % CI [8.30, 13.69], p＜ .00001; MD = 17.87; 95 % CI

* Corresponding author.
** Corresponding author.
E-mail addresses: [email protected] (C. Feng), [email protected] (J. Yao), [email protected] (Y. Xie), 742667026@qq.
com (M. Zhao), [email protected] (Y. Hu), [email protected] (Z. Hu), [email protected] (R. Li), [email protected] (H. Wu),
[email protected] (Y. Ge), [email protected] (F. Yang), [email protected] (X. Fan).
1
Chaoqun Feng and Junjie Yao contributed equally to this work.

https://doi.org/10.1016/j.heliyon.2024.e24229
Received 27 August 2023; Received in revised form 4 January 2024; Accepted 4 January 2024
Available online 6 January 2024
2405-8440/© 2024 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/).
C. Feng et al. Heliyon 10 (2024) e24229

[15.26, 20.48], p＜ .00001). Meta-analysis revealed no statistical differences in short-term (MD

= 1.34; 95 % CI [-3.19, 5.86], p = .56) and mid-term (MD = 2.75; 95 % CI [-1.21, 6.72], p = . 17)
functional improvement between the needle-knife and ESWT groups. In a subgroup analysis of
moderate-quality studies, the small needle-knife demonstrated a favorable effect on mid-term
functional improvement (MD = 1.58; 95 % CI [0.52, 2.65], p = .004), with low heterogeneity
(χ2 = 0.77, p = .038, I2 = 0 %). Conclusion: Pain reduction and functional improvement are
essential for the treatment of PF. Therefore, treatment using the small needle-knife may be su­
perior to ESWT. Results of this systematic review and meta-analysis may provide alternative
treatment options for patients with PF as well as more reliable, evidence-based recommendations
supporting use of the small needle-knife.

1. Introduction

Plantar fasciitis (PF) constitutes a group of syndromes caused by chronic degeneration and biomechanical changes in the proximal
plantar aponeurosis and is the most common cause of chronic heel pain among adults [1,2]. Pain is characterized most noticeably
during the initial steps after a period of inactivity, which usually regresses after walking for a period but eventually worsens following
excessive walking or running [3,4]. The number of individuals affected by PF is high, the disease is prone to occur repeatedly and is
difficult to treat [5]. It not only has a severe, negative impact on the activities of daily living of affected individuals but places high
economic and resource burdens on individuals and healthcare systems in various countries [6–10]. The pathological mechanisms
underlying PF remain unclear. Although many therapeutic methods are available, there is no consensus regarding a “gold standard”
treatment [11]. According to guidelines from the Orthopaedic Section of the American Physical Therapy Association (APTA) and the
American College of Foot and Ankle Surgeons (ACFAS) [1,12], modern medicine advocates taping, stretching, education, and
customized insoles or foot orthoses as core therapies. However, this is associated with many problems, such as prolonged treatment
period and poor patient acceptance and compliance. Guidelines recommend extracorporeal shock wave therapy (ESWT) for patients
who do not respond to such core therapies.
The small needle-knife is a new product based on Western medicine surgical techniques and traditional Chinese medicine (TCM)
acupuncture therapy, thus combining the dual effects of acupuncture and surgery, which has yielded good clinical efficacy in the
management of musculoskeletal pain disorders [13]. Several meta-analyses have demonstrated that treatment of PF using the small
needle-knife is safe and effective [14–16]. Presently, however, a lack of systematic reviews comparing small needle-knives and ESWT
persists. As such, we analyzed randomized controlled trials (RCTs) comparing the small needle-knife versus ESWT for the treatment of
PF. We objectively evaluated their clinical efficacies according to the systematic review research method, aiming to provide
evidence-based medical information to patients choosing the most appropriate treatment options. Our results may contribute to
optimizing TCM diagnosis and treatment strategies for PF.

2. Methods

2.1. Information sources and search strategies

A systematic literature search of the PubMed, EMBASE, Cochrane Library, Web of Science, ClinicalTrials.gov, China National
Knowledge Infrastructure (CNKI), Chongqing VIP Chinese Science and Technology Periodical (VIP), China Biology Medicine (CBM),
and Wanfang Databases for relevant studies, published from inception to July 2023, was performed. Keywords used in the search
included the following: (plantar fasciitis OR policeman’s heel OR heel pain OR heel spur syndrome OR chronic plantar fasciitis OR
plantar fasciopathy OR calcaneodynia) AND (small needle knife OR needle-knife OR acupuncture therapy OR acupotomy). Further­
more, the reference lists of the retrieved articles were also manually searched to identify other, potentially eligible studies. The
literature search was limited to studies published in English and Chinese. This systematic review and meta-analysis was registered in
the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42023448813). All search strategies are
described in Supplemental Appendix 1.

2.2. Eligibility criteria

Studies fulfilling the following criteria were included: participants were diagnosed as adult patients with PF; the small needle-knife
was selected as the primary intervention in the experimental group and ESWT was used in the control group (patients who underwent
treatment with both methods were excluded); outcome measures included the total effective rate or pain intensity; and an RCT design.
Duplicate publications and/or data were excluded.

2.3. Study selection and data extraction

The search results were imported into NoteExpress version 3.7.0, and study selection was performed independently by two of the
authors. First, duplicate publications were excluded. Second, the titles and abstracts of the remaining studies were screened for po­
tential eligibility. Third, potentially eligible studies were subjected to further full-text analysis to finalize study inclusion. The study

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selection results of the two authors were cross-checked, with any discrepancies resolved by a senior reviewer. Data extraction was
performed independently by the same authors using a standardized data extraction checklist. The extracted data included the
following: first author’s name; year of publication; country; study design; number of participants; disease duration; intervention
measures; intervention duration; outcome measures; and follow-up duration. Pain intensity and functional scores for each outcome
measure were transformed to scales graded from 0 to 100 points. Outcome measures were categorized according to length of follow-up,
if data were available. Therefore, follow-up of 1 month was defined as short term, 3 months as medium term, and >5 months as long
term.

Fig. 1. PRISMA flow diagram.

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Table 1
Characteristics of eligible studies.
Author/year Country Study No. Age Disease Intervention Intervention duration Outcome measures Follow-up Adverse Jada Quality
design (G1/ (year) duration measures (month) events score assessment
G2) (month)
G1 G2 G1 G2 G1 G2

Guo et al. China RCT 32/32 65.65 ± 2.11 ± 0.22 ESWT SNK + 1/2-3d, 1sess. Pain (NRS-101) 1, 3, 5 0 0 3 Moderate
(2015) 2.75 CI 3sess.
Huang et al. China RCT 30/30 45.22 ± 9.9 ± 2.89 ESWT SNK + 1/5-7d, 1/1w, Pain (Maryland) 1, 3, 6 0 0 3 Moderate
(2014) 5.80 Laser 3sess. 3sess. Function (Maryland)
Jiang et al. China RCT 30/30 45.38 ± 7.91 ± 2.79 ESWT SNK 2/1w, 1/1w, Pain (VAS) 1, 3 0 0 3 Moderate
(2020) 7.19 6sess. 3sess. Function (AOFAS,
Maryland)
4

Curative effect
Ren et al. China RCT 30/30 44.49 ± 6.37 ± 3.29 ESWT SNK 2/1w, 1/5-7d, Pain (VAS) 1, 3 0 0 2 Moderate
(2019) 14.03 6sess. 3sess. Function (AOFAS)
Curative effect
Wang et al. China RCT 39/36 55.63 ± 10.74 ± 1.97 ESWT SNK 1/3d, NR Pain (Maryland) 1 0 0 3 Moderate
(2017) 5.17 3sess. Function (Maryland)
Zhang et al. China RCT 38/38 69.79 ± 8.02 ± 4.46 ESWT SNK + 1/2-3d, 1sess. Pain (VAS) 1, 3, 6 0 0 3 Moderate
(2020) 3.24 CI 3sess. Function (SCL-36)
1L-1β, TNF-
αCurative effect

G = group; w = week; sess. = session; NR = not reported; NRS-101 = 101-point numeric rating scale; VAS = visual analog scale; AOFAS= American orthopedic foot and ankle society.
SCL-36 = symptom checklist 36; ESWT: extracorporeal shock wave therapy; SNK: Small needle-knife; CI: Corticosteroid injection.

Heliyon 10 (2024) e24229

C. Feng et al. Heliyon 10 (2024) e24229

2.4. Risk of bias assessment in individual studies

Two authors independently assessed the risk of bias using the assessment tool suggested in the Cochrane Handbook for Systematic
Reviews of Interventions [17]. Assessment of risk of bias included the following aspects: selection bias (random sequence generation
and allocation concealment); performance bias (blinding of participants and personnel); detection bias (blinding of outcome assess­
ment); attrition bias (incomplete outcome data); and reporting bias (selective reporting). The risk of bias for each item was classified as
“low”, “unclear”, or “high”. Any disagreements were resolved by consensus or arbitrated by a senior reviewer, if needed. RCT quality
was assessed according to the Jadad Scale [18].

2.5. Statistical analysis

Meta-analysis was performed using Review Manager version 5.4.1 (Copenhagen: Nordic Cochrane Centre, The Cochrane Collab­
oration, 2020). The odds ratio (OR) with corresponding 95％ confidence interval (CI) was used as an effect measure for dichotomous
data, and mean difference (MD) with corresponding 95％ CI was used for continuous data. Heterogeneity was measured using the I2
statistic and p-values. If p ≤ .1 and I2 ≥ 50 %, a random-effects model was used to pool the outcomes of studies; otherwise, a fixed-
effects model was used. Subgroup analysis was used to identify potential sources of heterogeneity in the studies. Sensitivity analysis
was performed by removing individual studies, one at a time, and recalculating the pooled estimates to explore the influence of in­
dividual RCTs. Because the number of eligible studies was limited, publication bias was not screened for. Cohen’s kappa index was
calculated to assess inter-rater agreement between the two primary reviewers [19].

3. Results

3.1. Study selection and characteristics

The initial literature search retrieved 886 studies for consideration (PubMed, n = 16; Embase, n = 8; Cochrane Library, n = 19; Web
of Science, n = 41; ClinicalTrials.gov, n = 3; CNKI, n = 121; VIP, n = 307; CBM, n = 152; and Wanfang, n = 219). No additional studies
were included after screening the reference lists of the retrieved studies investigating treatment for PF. After removing 300 duplicates,
the titles and abstracts of 586 studies were screened to identify those fulfilling the inclusion criteria, of which 6 were included after a
detailed, full-text review [20–25]. The overall agreement between the two primary reviewers for the eligible studies was excellent
(kappa = 0.91). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (i.e., “PRISMA”) flow-diagram illustrating
the study selection process is presented in Fig. 1.
Characteristics of the eligible studies included in this systematic review and meta-analysis are summarized in Table 1. In total, 395
subjects were included, of which 196 and 199 were allocated to the experimental and control groups, respectively. Three experimental
groups treated patients with PF using the small needle-knife alone [22–24], 2 with the small needle-knife plus corticosteroid injection
[20,25], and 1 with the small needle-knife plus laser treatment [21]. All control groups were treated with ESWT alone, with fre­
quencies ranging from 3 to 6 sessions (mean, 4 sessions). Three studies reported curative effects [22,23,25], and all reported
pain-related outcomes. Function-related outcomes were assessed in all studies except the study by Guo et al. [20].

3.2. Risk of bias assessment

The risk of bias assessment of the included RCTs is presented in Fig. 2. All studies described the generation of random sequences,

Fig. 2. Risk of bias graph.

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including 4 using the random number table method [21,22,24,25], 1 using random lots [20], and 1 reporting randomization without
specifying a specific randomization method [23]. Allocation concealment was not described in any of the included studies. The most
frequent bias was the inability to blind participants and therapists. None of the outcome data were lost to follow-up. Outcome data for
all participants were recorded. Jadad scores ranged from 2 to 3, with five trials scoring 3 (moderate quality) and 1 trial scoring 2 (low
quality).

3.3. Meta-analysis of measured outcomes

3.3.1. Curative effect

Three studies provided data regarding curative effects between the control and experimental groups [22,23,25], and a fixed-effect
model was used to report the pooled effect sizes. Meta-analysis revealed no significant differences in the treatment of PF between the
small needle-knife and ESWT groups(OR = 1.87; 95 % CI [0.80, 4.37], p = .15), with low heterogeneity between studies (χ2 = 1.31, p
= .52, I2 = 0 %) (Fig. 3).

3.3.2. Pain intensity

All included studies reported pain-related outcomes [20–25]. In the short-term follow-up subgroup, meta-analysis revealed that the
small needle-knife did not yield a significant difference in pain reduction compared with the control groups (MD = 2.20; 95 % CI
[− 2.77, 7.16], p = .39), and there was considerable heterogeneity between trials (χ2 = 63.77, p＜ .00001, I2 = 92 %). In the mid-term
follow-up subgroup, meta-analysis revealed that a small needle-knife was more effective than ESWT for pain improvement (MD = 9.11;
95 % CI [5.08, 13.15], p＜ .00001), with significant heterogeneity (χ2 = 27.18, p＜ .00001, I2 = 85 %).The small needle-knife also
yielded a significant long-term effect in reducing pain intensity compared with the control group (MD = 10.71; 95 % CI [2.18, 19.25], p
＜.00001), although heterogeneity was significant (χ2 = 43.68, p＜ .00001, I2 = 95 %)(Fig. 4). Given the significant heterogeneity
among the studies, subgroup analyses were also performed according to intervention type and quality of the RCTs (Table 2).
The subgroup of combination of small needle-knife plus corticosteroid injection demonstrated significant statistical differences in
pain intensity reduction compared with the control group over the 3 follow-up periods (MD = 4.84; 95 % CI [1.33, 8.36], p = .007; MD
= 10.99; 95 % CI [8.30, 13.69], p＜ .00001; MD = 17.87; 95 % CI [15.26, 20.48], p＜ .00001). However, there was significant
heterogeneity in all follow-up periods (χ2 = 3.24, p = .07, I2 = 69 %; χ2 = 2.33, p = .13, I2 = 57 %; χ2 = 2.55, p = .11, I2 = 61 %). In the
subgroup of moderate-quality studies, the small needle-knife group was statistically superior to the control group in terms of mid-term
and long-term pain reduction (MD = 8.11; 95 % CI [3.95, 12.28], p = .00001; MD = 10.71; 95 % CI [2.18, 19.25], p = .01), although
significant heterogeneity persisted (χ2 = 23.78, p＜ .00001, I2 = 87 %; χ2 = 43.68, p＜ .00001, I2 = 95 %).

3.3.3. Function
Five studies assessed the effect of the small needle-knife versus ESWT in improving patient function [21–25]. The pooled data
demonstrated no statistical differences in short-term (MD = 1.34; 95 % CI [− 3.19, 5.86], p = .56) and mid-term efficacy (MD = 2.75;
95 % CI [− 1.21, 6.72], p = .17) between small-needle knife therapy and ESWT in improving function. There was considerable het­
erogeneity in the short-term (χ2 = 41.82, p＜ .00001, I2 = 90 %) and mid-term follow-up studies(χ2 = 6.39, p = .04, I2 = 69 %) (Fig. 5).
Unfortunately, only 1 RCT reported long-term functional follow-up [21], which was insufficient for meta-analysis.
The only valuable comparison was observed in the subgroup analysis of moderate quality studies, in which the small needle-knife
demonstrated a significant mid-term effect in terms of functional improvement over ESWT (MD = 1.58; 95 % CI [0.52, 2.65], p =
.004), with low heterogeneity (χ2 = 0.77, p = .038, I2 = 0 %) (Table 3). In the short-term follow-up subgroup of small needle-knife
combined with corticosteroid injection and the mid-term subgroup of low-quality studies, the small needle-knife demonstrated a
significant effect on ESWT in improving function (MD = 10.40; 95 % CI [7.38, 13.42], p＜ .00001; MD = 6.40; 95 % CI [2.56, 10.24], p
= .001). However, both subgroup analyses were based on a single study design.

3.4. Adverse events

Six studies did not report data regarding side effects or adverse events during the treatment and follow-up periods.

Fig. 3. The meta-analysis results of curative effects.

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Fig. 4. The meta-analysis results of pain intensity.

Table 2
Subgroup analysis of pain intensity.
Outcomes Subgroups Number of Effects estimate (95 % CI), p value Heterogeneity
Studies

Pain intensity (Short-term follow- SNK ESWT 3 MD = − 1.37; 95 % CI [-15.37, 12.63], p = χ2 = 60.16, p＜.00001, I2 = 97
up) .85 %
SNK + ESWT 2 MD = 4.84; 95 % CI [1.33, 8.36], p = .007 χ2 = 3.24, p = .07, I2 = 69 %
CI
Pain intensity (Mid-term follow- SNK ESWT 2 MD = 9.85; 95 % CI [-2.30, 22.00], p = .11 χ2 = 6.93, p = .008, I2 = 86 %
up) SNK + ESWT 2 MD = 10.99; 95 % CI [8.30, 13.69], p χ2 = 2.33, p = .13, I2 = 57 %
CI ＜.00001
Pain intensity (Long-term follow- SNK ESWT 0 NR NR
up) SNK + ESWT 2 MD = 17.87; 95 % CI [15.26, 20.48], p χ2 = 2.55, p = .11, I2 = 61 %
CI ＜.00001
Pain intensity (Short-term follow- Jada score≥3 5 MD = 2.24; 95 % CI [-3.30, 7.77], p = .43 χ2 = 63.28, p＜.00001, I2 = 94
up) %
Jada score＜3 1 MD = 1.90; 95 % CI [-4.86, 8.66], p = .58 NR
Pain intensity (Mid-term follow- Jada score≥3 4 MD = 8.11; 95 % CI [3.95, 12.28], p = χ2 = 23.78, p＜.00001, I2 = 87
up) .00001 %
Jada score＜3 1 MD = 16.90; 95 % CI [7.86, 25.94], p = NR
.0002
Pain intensity (Long-term follow- Jada score≥3 3 MD = 10.71; 95 % CI [2.18, 19.25], p = .01 χ2 = 43.68, p＜.00001, I2 = 95
up) %
Jada score＜3 0 NR NR

NR = not reported; SNK: Small needle-knife; CI: Corticosteroid; ESWT: extracorporeal shock wave therapy.

4. Discussion

PF is a common public health problem involving the foot and ankle, and mechanical factors are believed to contribute to its main
causes. ESWT is the recommended treatment modality in both the APTA and ACFAS guidelines [1,12], and PF is the first orthopedic
disease approved by the Food and Drug Administration for treatment with ESWT [26]. Although ESWT is generally considered to be a
safe and effective treatment for chronic PF, it is undeniable that some patients cannot tolerate the pain of ESWT, and some continue to
experience pain, edema, ecchymosis, hypoesthesia, paresthesia, and even foot spasm after the procedure [27]. If anesthetics are
administered during ESWT to reduce intraoperative pain, efficacy may also decrease [28,29]. However, accumulating evidence
suggests that needle therapy can also be used to treat PF. An updated meta-analysis suggested a positive effect of trigger-point dry
needling in improving pain intensity and pain-related disability in patients with PF of musculoskeletal origin [30]. Some results from

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Fig. 5. The meta-analysis results of function.

Table 3
Subgroup analysis of function.
Outcomes Subgroups Number of Effects estimate (95 % CI), p value Heterogeneity
Studies

Function (Short-term follow- SNK ESWT 3 MD = 0.29; 95 % CI [-3.01, 3.60], p = .86 χ2 = 8.01, p = .02, I2 = 75 %
up) SNK + CI ESWT 1 MD = 10.40; 95 % CI [7.38, 13.42], p NR
＜.00001
Function (Mid-term follow-up) SNK ESWT 2 MD = 3.65; 95 % CI [-0.96, 8.26], p = .12 χ2 = 5.48, p = .02, I2 = 82 %
SNK + CI ESWT 0 NR NR
Function (Short-term follow- Jada score≥3 4 MD = 0.61; 95 % CI [-5.90, 7.13], p = .85 χ2 = 41.78, p＜.00001, I2 = 93 %
up) Jada score＜3 1 MD = 2.43; 95 % CI [-0.47, 5.33], p = .10 NR
Function (Mid-term follow-up) Jada score≥3 2 MD = 1.58; 95 % CI [0.52, 2.65], p = .004 χ2 = 0.77, p = .038, I2 = 0 %
Jada score＜3 1 MD = 6.40; 95 % CI [2.56, 10.24], p = .001 NR

NR = not reported.

RCTs revealed that the combination of needle therapy with manipulation, exercise, stretching and ultrasound therapy can enhance the
curative effect of PF [31,32]. As a complementary and alternative therapy, the small needle-knife yields a significant clinical effect on
musculoskeletal diseases and, as such, has promising prospects for popularization and application. Presently, the results of several
RCTs suggest that the small needle-knife can effectively reduce symptoms in patients with PF and improve the levels of inflammatory
factors [20–25]. However, there is no evidence-based data for its comparison with ESWT. Finally, the curative effects, pain intensity,
and function were analyzed in our study.
Results of the present systematic review and meta-analysis revealed no statistical differences in the curative effect between the
small needle-knife and ESWT, although multiple RCTs have reported that the small needle-knife was superior to the ESWT. Previous
studies have reported variable success rates of ESWT in terms of pain reduction, ranging from 55 % to 88 %, during short or mid-term
follow-ups [33–35],while our study ranged from 76 % to 86 %. We speculate that this difference is related to the selection of different
types or intensities of ESWT. In fact, there has been controversy regarding the effectiveness of different types of ESWT, and no
consensus has been reached so far [36].In view of the fact that pain reduction and functional improvement are essential for PF
treatment, this meta-analysis found that the small needle-knife was more effective than ESWT for pain improvement in the mid-term
and long-term follow-ups. Similar to the findings of the current study, the effect of the small needle-knife on long-term pain
improvement was found to be better in other studies [14,15]. PF is caused by excessive load and extension of the plantar fascia,
resulting in local stress changes at the attachment of the plantar fascia and calcaneal nodules. A cadaveric study demonstrated that
partial plantar fasciotomy can be achieved via percutaneous plantar fascia release with a conventional hypodermic needle without
causing any nerve damage [38]. Small needle-knife therapy can also effectively separate and decompress the contracture of diseased
tissue, which can fundamentally solve the problem at the heel [37]. This may explain why it provides better mid-term and long-term
pain relief. We also observed significant heterogeneity among the included studies. Comprehensive subgroup analyses were performed
based on different variables to attenuate the observed heterogeneity. However, heterogeneity did not change according to the length of
follow-up, intervention type, or RCT quality. A subgroup analysis found that a small needle-knife combined with glucocorticoid in­
jection helped reduce pain intensity in patients with PF in the 3 follow-up periods. Subgroups analysis of moderate-quality studies
revealed that pain reduction at mid-term and long-term follow-up with the small needle-knife was better than that with ESWT. In
contrast, functional data demonstrated the advantage of using the small needle-knife at mid-term follow-up only in a subgroup of
moderate-quality studies. On the one hand, this may be because the sample size was small and only 2 studies reported function in the

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mid-term stage, resulting in insufficient, relevant data. However, this may be because the American Orthopaedic Foot and Ankle Score
lacks specificity for PF [39]. This further contributed to the low quality of the evidence, and its actual effect may differ from the
calculated result.
In addition, compared with ESWT, the small needle-knife has fewer side effects, and patients treated with the small needle-knife can
return to the activities of daily living and work sooner. However, the mechanism by which the small needle-knife impacts kinematics,
dynamics, muscle activity, and sensory feedback in altering tissue load is unclear and warrants further study.
The present study had some limitations. First, the ESWT parameters and the operational details of the small needle-knife in the
included studies were not completely consistent. Second, the 6 included studies were all from China, and only 1 had negative results; as
such, clinicians need to be alert to the possibility of bias for these positive results. Third, the lack of blinding in the studies may have
contributed to the overestimation of these outcomes. As such, the results should be interpreted with caution.

5. Conclusion

This was the first systematic review and meta-analysis to compare the small needle-knife and ESWT for the treatment of PF. Overall,
the results demonstrated similar curative effects for the small needle-knife and ESWT in the treatment of PF. However, treatment using
the small needle-knife may provide an interesting alternative with better outcomes in terms of pain reduction and functional
improvement than ESWT in the management of PF. The results of this systematic review and meta-analysis provide reliable, evidence-
based data supporting the use of small needle-knives. The conclusions of evidence-based medicine can promote further scientific
research and provide more reliable data. Therefore, high-quality RCTs with multiple centers and large samples are needed to further
demonstrate the efficacy of the small needle-knife in the treatment of PF, and continual investigation into the pathological mechanisms
underlying PF is also warranted.

Funding

This work is supported by grants from Natural Science Foundation of Sichuan Province (23NSFSC2296) and the Chinese Medicine
Living Inheritance and Talent Team Building Project (CJJ2021048).

Data Availability

Data will be made available on request.

CRediT authorship contribution statement

Chaoqun Feng: Writing - original draft, Methodology, Conceptualization. Junjie Yao: Writing - original draft, Methodology,
Conceptualization. Yizhou Xie: Writing - review & editing. Min Zhao: Methodology, Investigation, Data curation. Youpeng Hu:
Visualization, Formal analysis. Ziang Hu: Methodology, Investigation, Data curation. Ruoyan Li: Visualization, Formal analysis.
Haoyang Wu: Writing - original draft. Yuanxin Ge: Writing - original draft. Fei Yang: Writing - review & editing. Xiaohong Fan:
Writing - review & editing.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to
influence the work reported in this paper.

Acknowledgments

Not applicable.

Appendix A. Supplementary data

Supplementary data to this article can be found online at https://doi.org/10.1016/j.heliyon.2024.e24229.

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Abbreviations

ACFAS: American College of Foot and Ankle Surgeons

APTA: American Physical Therapy Association
CBM: China Biology Medicine
CI: Confidence Interval
CNKI: China National Knowledge Infrastructure
ESWT: Extracorporeal Shock Wave Therapy
MD: Mean Difference
OR: Odds Ratio
PF: Plantar fasciitis
RCT: Randomized Controlled Trial
RCTs: Randomized Controlled Trials
TCM: Traditional Chinese Medicine

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VIP: Chongqing VIP Chinese Science and Technology Periodical

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