Abstract
Purpose
To determine whether adding myofascial trigger point (MTrP)–targeted dry needling to conventional acupuncture improves short-term pain and function response in adults with early- to mid-stage knee osteoarthritis (KOA).
Patients and methods
In this randomized, assessor-blinded, single-center trial, 106 adults with Kellgren–Lawrence grade II–III KOA were assigned 1:1 to conventional acupuncture or the same regimen plus 3 individualized MTrP-targeted insertions. Both groups received 10 sessions over 2 weeks. The primary outcome was the week-2 composite responder rate, defined as a ≥2-point reduction in visual analog scale (VAS) pain and a ≥6-point improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function. Secondary outcomes included pain, function, pressure pain threshold (PPT), gait, acceptability, and safety.
Results
Of 106 randomized participants, 97 were included in the modified intention-to-treat analysis. At week 2, 47 of 49 participants (95.9%) in the MTrP-augmented group and 42 of 48 (87.5%) in the conventional group were responders (risk difference, 8.4 percentage points [95% CI, −2.5 to 19.3]; risk ratio, 1.10 [95% CI, 0.97 to 1.24]; P =0.13). Exploratory secondary analyses without comprehensive multiplicity adjustment favored MTrP augmentation for VAS pain and WOMAC outcomes. The week-2 between-group difference in gait-speed change was 0.072 m/s (95% CI, 0.040 to 0.103; nominal P <0.001), and group-by-time interactions occurred at 6 of 7 shared peri-knee PPT sites. At week 2, needling pain was 2.45 points higher and acceptability was lower with MTrP augmentation (36.7% vs 72.9%). No serious adverse events or related withdrawals occurred.
Conclusion
Adding MTrP-targeted dry needling to conventional acupuncture did not significantly improve the prespecified primary responder outcome; therefore, superiority was not established. Exploratory findings suggested possible incremental benefits through week 14, but these should be weighed against greater procedural pain and substantially lower short-term acceptability.
Keywords: knee osteoarthritis, acupuncture, myofascial trigger points, randomized clinical trial, gait, pressure pain threshold
Introduction
Knee osteoarthritis (KOA) is a major cause of chronic pain and disability, with an increasing burden associated with population aging and obesity.1 In China, its age-standardized prevalence and disability burden have increased since 1990.2 Structural and inflammatory changes within the joint contribute to pain, stiffness, and functional limitation.3,4 Pharmacologic treatments may relieve symptoms but are limited by safety concerns and uncertainty regarding repeated use, particularly in older adults with multimorbidity.5,6 Nonpharmacologic management therefore remains central and commonly includes education, therapeutic exercise, weight management, balance training, and individualized rehabilitation.7 Technology-supported approaches, including virtual reality–based exercise, are also being evaluated.8
Acupuncture may improve pain and function in patients with KOA, although recommendations across clinical practice guidelines remain inconsistent.9,10 Conventional acupuncture uses prespecified meridian-based acupoints, whereas Ashi-point acupuncture targets individualized painful or tender sites. Myofascial trigger point (MTrP)–targeted dry needling selects hypersensitive loci within palpable taut bands of skeletal muscle using predefined clinical criteria.11 Although Ashi points and MTrPs may overlap anatomically, they are not conceptually or operationally identical.12 Proposed mechanisms of MTrP-targeted dry needling include modulation of local muscle tone, tissue perfusion, and nociceptive processing.13
Evidence for MTrP-directed needling in KOA remains limited by small sample sizes, heterogeneous treatment protocols, and differing comparators.14 A preliminary randomized trial comparing trigger-point acupuncture with standard and sham acupuncture suggested potentially greater improvement with trigger-point treatment; however, only 30 participants were included, and the intervention differed substantially from that used in the present study.15 Therefore, whether individualized MTrP-targeted dry needling provides additional benefit when added to an otherwise identical conventional acupuncture regimen remains uncertain.
Pressure pain threshold (PPT) can quantify mechanical pain sensitivity, whereas quantitative gait analysis provides an objective assessment of lower-extremity function beyond patient-reported outcomes.16,17 We therefore conducted a randomized, assessor-blinded clinical trial in adults with early- to mid-stage KOA.18 Both groups received the same standardized conventional acupuncture regimen, while the intervention group received 3 additional individualized MTrP-targeted dry-needling insertions. The prespecified primary objective was to determine whether MTrP-augmented acupuncture improved a composite responder outcome based on pain and function. Secondary objectives were to explore changes in pain, function, PPT, and gait biomechanics.
Methods
Study Design and Setting
This randomized, assessor-blinded, parallel-group clinical trial was conducted at the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine between July 19, 2023, and June 30, 2024. The trial was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2300073707), and the protocol was published previously.18 The study was approved by the Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TYLL2023[K]011), and all participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and reported following CONSORT 2025 and STRICTA.19,20
Participants
Participants were recruited through outpatient clinics, community advertisements, and hospital social media. Eligible participants were aged 18 to 70 years, met the American College of Rheumatology criteria for KOA,21 had Kellgren–Lawrence grade II or III disease, had symptoms for at least 6 months, and reported mean knee pain of at least 4 on a 0-to-10 visual analog scale (VAS) during the preceding week.
Exclusion criteria were previous knee surgery; intra-articular injection within 4 months; acupuncture within 3 months; knee pain caused by infection, malignancy, autoimmune disease, trauma, or another secondary condition; coagulation disorders; pregnancy; psychiatric illness; or participation in another clinical trial within 3 months. For bilateral KOA, 1 knee was selected for assessment; when both knees were eligible, the more painful knee was evaluated.
Randomization and Blinding
Participants were randomized 1:1 to conventional acupuncture or MTrP-augmented acupuncture using a computer-generated sequence. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. The augmented group received conventional acupuncture plus 3 additional MTrP-targeted dry-needling insertions. Participants and acupuncturists were not blinded; outcome assessors, data managers, and statisticians remained blinded to treatment allocation.
Interventions
Both groups received 10 sessions over 2 consecutive weeks, with 5 sessions per week. Treatments were administered by licensed acupuncturists with more than 10 years of clinical experience.
The conventional acupuncture regimen included Dubi (ST35), Neixiyan (EX-LE4), Zusanli (ST36), Yanglingquan (GB34), Xuehai (SP10), Liangqiu (ST34), and Heding (EX-LE2).22 Sterile disposable needles (0.25 × 40 mm) were inserted to a depth of 10 to 30 mm, manually stimulated for 10 seconds to elicit Deqi, and retained for 30 minutes. No reinforcing or reducing manipulation or additional stimulation was performed during retention.
Clinicians responsible for MTrP identification received standardized training in predefined diagnostic criteria and a 4-grade tenderness scale.23 Tenderness was classified as mild (grade 1), moderate (grade 2), pain accompanied by facial grimacing or verbal expression (grade 3), or withdrawal or resistance to pressure (grade 4). Before the first treatment, 2 trained physicians independently palpated candidate MTrPs, primarily in the vastus medialis and gastrocnemius, and measured PPT. The 3 most tender grade 3 or 4 sites were selected, photographed, and documented. The same sites were treated throughout all 10 sessions. No formal interrater reliability coefficient was calculated.
Each selected MTrP received 1 additional needle insertion using the same needle dimensions, insertion depth, stimulation duration, and retention time as conventional acupuncture. The augmented regimen therefore involved 3 additional insertions and a greater overall stimulation dose.
No further protocol treatment was provided after week 2. The week-6 and week-14 visits were assessment-only visits. Participants were instructed to avoid other acupuncture, physical therapy, moxibustion, and injection-based treatments through week 14. Acetaminophen was permitted as rescue medication when VAS pain was at least 8, and all use was recorded.
Follow-Up and Outcomes
Outcomes were assessed at baseline and at weeks 1, 2, 6, and 14. The week-6 and week-14 assessments occurred 4 and 12 weeks after completion of treatment, respectively.
The prespecified primary outcome was the week-2 composite responder rate. A responder was defined as achieving both a reduction of at least 2 points in VAS knee pain and an improvement of at least 6 points in WOMAC function from baseline.24 The VAS ranged from 0 to 10, with higher scores indicating greater pain. The WOMAC function subscale contains 17 items scored from 0 to 4, with higher scores indicating greater impairment.25,26
Secondary outcomes included VAS pain; WOMAC pain, stiffness, function, and total scores; peri-knee and MTrP-specific PPT; 3-dimensional gait parameters; needling pain; treatment acceptability and adherence; rescue medication use; and adverse events.
PPT was measured using a digital pressure algometer (FPX25; Wagner Instruments). Participants were seated with the assessed knee flexed to 90°. Pressure was applied perpendicular to the marked site at approximately 50 N/s until pressure was first perceived as painful. Each site was measured 3 times at 30-second intervals, and the mean was analyzed. The 7 conventional acupoints were assessed in both groups; the 3 individualized MTrPs were assessed only in the augmented group.
Gait was assessed using the Right Gait Posture Medical 3.0 system (Shenzhen Xingzheng Technology Co Ltd). Participants walked at a self-selected pace for 2 minutes while wearing instrumented insoles. Outcomes included gait speed, cadence, single-leg support time, swing phase, sagittal initial-contact and toe-off angles, coronal initial varus angle, and ground clearance.
Needling pain was assessed using a 0-to-10 numeric rating scale after the first session and at weeks 1 and 2. Treatment acceptability was assessed at the same time points by asking whether participants would be willing to receive the same treatment again.
Adverse Events
Adverse events were monitored through week 14. Needling-site pain, minor bleeding, bruising or hematoma, and other untoward events were recorded. Investigators assessed event severity and treatment relatedness. Serious adverse events were reported within 24 hours and managed according to the protocol.
Sample Size
Based on pilot-estimated week-2 responder rates of 91.7% with MTrP-augmented acupuncture and 73.0% with conventional acupuncture, 48 participants per group were required. Allowing for 10% attrition, the target sample size was 106 participants.18
Statistical Analysis
The statistical analysis plan is provided in Supplement 1. Continuous and categorical variables were summarized as mean (SD) and number (percentage), respectively. The modified intention-to-treat population included randomized participants who received at least 1 treatment and provided postbaseline outcome data.
Week-2 responder rates were compared using the Pearson χ2-test. Risk differences and risk ratios were reported with 95% CIs. A sensitivity analysis included all 106 randomized participants and classified the 9 participants without postbaseline data as nonresponders. Post hoc analyses used more stringent composite definitions requiring a VAS reduction of at least 3 or 4 points together with a WOMAC function improvement of at least 8 points.
Repeated continuous outcomes were analyzed using linear mixed-effects models with fixed effects for group, categorical time, and group-by-time interaction and a participant-specific random intercept. No covariates were included. Between-group differences were estimated from marginal means with 95% CIs, and model assumptions were assessed using residual plots. Binary secondary outcomes were analyzed using the Pearson χ2 or Fisher exact test.
Longitudinal models used all available observations under a missing-at-random assumption without imputation. All tests were 2-sided, with P <0.05 considered statistically significant. Except for Tukey-adjusted comparisons of MTrP sites, secondary and post hoc analyses were exploratory and were not adjusted for multiplicity.
Results
Participant Characteristics
Nine participants had no postbaseline outcome data. In the MTrP-augmented group, 3 were lost to follow-up or could not be contacted and 1 withdrew for personal reasons; in the conventional acupuncture group, 4 were lost to follow-up or could not be contacted and 1 withdrew for personal reasons. Of 106 randomized participants, 97 were included in the modified intention-to-treat analysis set: 49 in the MTrP-augmented group and 48 in the conventional acupuncture group (Figure 1). Baseline demographic and clinical characteristics were similar between groups (Table 1). Baseline peri-knee PPT values were also similar, except at Liangqiu (ST34), where the conventional group had a higher mean (SD) PPT than the MTrP-augmented group (3.20 [0.59] vs 2.96 [0.57]; P =0.039). PPT at MTrP sites was assessed only in the MTrP-augmented group.
Figure 1.
CONSORT flow diagram of participant enrollment, allocation, follow-up, and analysis.
Abbreviation: MTrP, myofascial trigger point.
Table 1.
Baseline Characteristics of the Participants
| Variable | MTrP Group (n = 49) | Control Group (n = 48) | P value |
|---|---|---|---|
| General characteristics | |||
| Sex, male/female, n (%) | 20 (40.8) / 29 (59.2) | 21 (43.8) / 27 (56.2) | 0.931 |
| Age, years | 56.88 ± 8.62 | 57.35 ± 7.63 | 0.773 |
| Body mass index, kg/m2 | 25.50 ± 3.31 | 25.49 ± 2.16 | 0.997 |
| Affected sidea, 1/2, n (%) | 25 (51.0) / 24 (49.0) | 25 (52.1) / 23 (47.9) | 1.000 |
| Disease duration, months | 28.88 ± 5.51 | 31.15 ± 7.72 | 0.100 |
| Pain and function (baseline) | |||
| VAS score | 5.51 ± 0.89 | 5.31 ± 0.95 | 0.293 |
| WOMAC total score | 57.22 ± 8.98 | 55.23 ± 7.18 | 0.229 |
| Gait parameters (baseline) | |||
| Gait speed, m/s | 0.73 ± 0.09 | 0.74 ± 0.08 | 0.597 |
| Cadence, steps/min | 83.57 ± 8.61 | 82.08 ± 7.32 | 0.362 |
| Single-leg support time, % | 48.94 ± 5.13 | 47.23 ± 3.83 | 0.066 |
| Swing phase, % | 51.06 ± 5.13 | 52.77 ± 3.83 | 0.066 |
| Sagittal initial contact angle, ° | 8.63 ± 1.18 | 8.35 ± 1.02 | 0.204 |
| Sagittal toe-off angle, ° | 48.79 ± 3.99 | 47.78 ± 3.66 | 0.198 |
| Coronal initial varus angle, ° | 17.72 ± 2.03 | 17.82 ± 2.02 | 0.809 |
| Coronal ground clearanceb | 11.47 ± 2.09 | 11.22 ± 1.49 | 0.491 |
| Peri-knee pressure pain threshold (baseline)c | |||
| Dubi (ST35) | 2.85 ± 0.58 | 2.88 ± 0.49 | 0.826 |
| Neixiyan (EX-LE4) | 2.82 ± 0.49 | 2.78 ± 0.43 | 0.727 |
| Zusanli (ST36) | 3.01 ± 0.62 | 3.16 ± 0.58 | 0.220 |
| Yanglingquan (GB34) | 2.97 ± 0.54 | 3.01 ± 0.50 | 0.697 |
| Xuehai (SP10) | 2.92 ± 0.47 | 2.85 ± 0.44 | 0.424 |
| Liangqiu (ST34) | 2.96 ± 0.57 | 3.20 ± 0.59 | 0.039 |
| Heding (EX-LE2) | 2.63 ± 0.42 | 2.56 ± 0.38 | 0.391 |
| MTrP 1 | 3.27 ± 1.47 | — | — |
| MTrP 2 | 3.47 ± 1.85 | — | — |
| MTrP 3 | 2.64 ± 0.84 | — | — |
Notes: Data are presented as mean ± standard deviation or number (percentage). a The affected side was coded as 1 or 2, representing left or right (or affected/unaffected side, as specified in the main text). b The unit of coronal ground clearance was defined according to the gait analysis system (mm). c Pressure pain threshold (PPT) values were measured using a pressure algometer, with units defined by the device (kg/cm2). MTrP 1–3 were assessed only in the myofascial trigger point (MTrP) group; therefore, no between-group comparisons were performed for these variables. P values were calculated using the χ2-test for categorical variables and independent-samples t tests with Welch correction for continuous variables (2-sided). A P value <0.05 was considered statistically significant.
Primary Outcome
At week 2, the composite responder rate was 95.9% (47/49; 95% CI, 90.4–100.0%) in the MTrP-augmented group and 87.5% (42/48; 95% CI, 78.1–96.9%) in the conventional group (Table 2). The risk difference was 8.4 percentage points (95% CI, −2.5 to 19.3), and the risk ratio was 1.10 (95% CI, 0.97–1.24; P =0.132).
Table 2.
Changes in Clinical Outcomes within and Between Groups
| Outcome | Change within Groups, Mean (95% CI)a | Difference in Change Between Groups, Mean (95% CI)b | Cohen d (95% CI) | P value | |
|---|---|---|---|---|---|
| MTrP Group (n = 49) | Control Group (n = 48) | ||||
| WOMAC total score | |||||
| Week 1 of treatment | −35.3 (−38.5 to −32.1) | −30.0 (−32.4 to −27.6) | −5.3 (−9.3 to −1.2) | −0.5 (−0.9 to −0.1) | 0.011 |
| Week 2 of treatment | −39.8 (−42.5 to −37.1) | −34.5 (−36.2 to −32.7) | −5.3 (−8.9 to −1.7) | −0.6 (−1.0 to −0.2) | 0.004 |
| 1 month post-treatment | −23.7 (−27.3 to −20.1) | −17.0 (−19.5 to −14.4) | −6.7 (−11.1 to −2.3) | −0.6 (−1.0 to −0.2) | 0.003 |
| 3 months post-treatment | −11.9 (−14.9 to −8.8) | −4.9 (−8.1 to −1.8) | −6.9 (−11.6 to −2.3) | −0.6 (−1.0 to −0.2) | 0.004 |
| WOMAC pain subscale | |||||
| Week 1 of treatment | −7.4 (−8.1 to −6.8) | −6.3 (−6.8 to −5.8) | −1.2 (−2.0 to −0.3) | −0.5 (−0.9 to −0.1) | 0.009 |
| Week 2 of treatment | −8.3 (−8.8 to −7.7) | −7.3 (−7.8 to −6.7) | −1.1 (−1.9 to −0.3) | −0.5 (−0.8 to −0.1) | 0.010 |
| 1 month post-treatment | −5.0 (−5.8 to −4.3) | −3.6 (−4.2 to −3.1) | −1.4 (−2.3 to −0.4) | −0.6 (−1.0 to −0.2) | 0.005 |
| 3 months post-treatment | −2.5 (−3.1 to −1.9) | −1.2 (−1.9 to −0.4) | −1.3 (−2.3 to −0.3) | −0.5 (−0.9 to −0.1) | 0.011 |
| WOMAC stiffness subscale | |||||
| Week 1 of treatment | −3.0 (−3.3 to −2.7) | −2.4 (−2.7 to −2.2) | −0.6 (−1.0 to −0.2) | −0.6 (−1.0 to −0.2) | 0.005 |
| Week 2 of treatment | −3.3 (−3.6 to −3.0) | −2.7 (−3.0 to −2.5) | −0.6 (−0.9 to −0.2) | −0.6 (−1.0 to −0.2) | 0.002 |
| 1 month post-treatment | −2.0 (−2.4 to −1.6) | −1.4 (−1.7 to −1.1) | −0.6 (−1.0 to −0.2) | −0.6 (−1.0 to −0.2) | 0.003 |
| 3 months post-treatment | −1.0 (−1.3 to −0.7) | −0.3 (−0.6 to 0.0) | −0.8 (−1.2 to −0.3) | −0.7 (−1.1 to −0.3) | 0.001 |
| WOMAC function subscale | |||||
| Week 1 of treatment | −24.9 (−27.2 to −22.6) | −21.3 (−23.1 to −19.6) | −3.6 (−6.4 to −0.7) | −0.5 (−0.9 to −0.1) | 0.015 |
| Week 2 of treatment | −28.2 (−30.0 to −26.3) | −24.5 (−26.2 to −22.8) | −3.7 (−6.3 to −1.2) | −0.6 (−1.0 to −0.2) | 0.004 |
| 1 month post-treatment | −16.7 (−19.2 to −14.1) | −12.0 (−13.8 to −10.1) | −4.7 (−7.9 to −1.6) | −0.6 (−1.0 to −0.2) | 0.004 |
| 3 months post-treatment | −8.4 (−10.6 to −6.2) | −3.5 (−6.0 to −1.0) | −4.9 (−8.2 to −1.6) | −0.6 (−1.0 to −0.2) | 0.004 |
| VAS knee pain scorec | |||||
| Week 1 of treatment | −3.7 (−3.9 to −3.5) | −3.0 (−3.3 to −2.7) | −0.7 (−1.0 to −0.3) | −0.7 (−1.1 to −0.3) | 0.001 |
| Week 2 of treatment | −3.9 (−4.2 to −3.5) | −3.4 (−3.7 to −3.1) | −0.4 (−0.9 to 0.0) | −0.4 (−0.8 to 0.0) | 0.071 |
| 1 month post-treatment | −2.5 (−2.8 to −2.2) | −1.9 (−2.2 to −1.6) | −0.6 (−1.0 to −0.2) | −0.6 (−1.0 to −0.2) | 0.003 |
| 3 months post-treatment | −1.4 (−1.7 to −1.1) | −0.6 (−0.9 to −0.4) | −0.7 (−1.2 to −0.3) | −0.7 (−1.1 to −0.3) | 0.001 |
| Composite responder rate at 2 weeksd | |||||
| Week 2 of treatment | 47/49 (95.9%, 90.4–100.0) | 42/48 (87.5%, 78.1–96.9) | 8.4% (−2.5 to 19.3) | RR 1.10 (0.97–1.24) | 0.132 |
Notes: a Change values were calculated as follow-up value minus baseline value; negative values indicate symptom reduction or functional improvement. b Between-group difference was calculated as change in the MTrP group minus change in the control group; negative values indicate greater improvement in the MTrP group. c The VAS score ranges from 0 to 10, with higher scores indicating more severe pain. d The composite responder rate at 2 weeks was defined as the proportion of patients achieving both a reduction of ≥2 points in mean VAS pain score and an improvement of ≥6 points in WOMAC function score compared with baseline.
In the conservative intention-to-treat sensitivity analysis, which classified the 9 participants without postbaseline data as nonresponders, responder rates were 88.7% (47/53) and 79.2% (42/53), respectively (risk difference, 9.4 percentage points [95% CI, −4.4 to 23.3]; risk ratio, 1.12 [95% CI, 0.95–1.32]; P =0.186). In the first post hoc analysis, defined as a VAS pain reduction of at least 3 points together with a WOMAC function improvement of at least 8 points, responder rates were 89.8% (44/49) in the MTrP-augmented group and 81.3% (39/48) in the conventional acupuncture group (risk difference, 8.5 percentage points [95% CI, −5.4 to 22.5]; risk ratio, 1.11 [95% CI, 0.94 to 1.30]; P =0.231). Under the more stringent definition of a VAS pain reduction of at least 4 points together with a WOMAC function improvement of at least 8 points, responder rates were 57.1% (28/49) and 43.8% (21/48), respectively (risk difference, 13.4 percentage points [95% CI, −6.3 to 33.1]; risk ratio, 1.31 [95% CI, 0.87 to 1.95]; P =0.18) (Supplement 2 eTable 1).
Pain and Function Outcomes
Pain and function scores decreased from baseline in both groups during the 14-week study period (Table 2; Figure 2; Supplement 2 eTables 2 and 3). Model-based between-group differences in change favored the MTrP-augmented group at weeks 1, 2, 6, and 14 for VAS pain (−0.44 to −0.74 points; all nominal P ≤.043), WOMAC pain (−1.1 to −1.4 points; all nominal P ≤.016), stiffness (−0.6 to −0.8 points; all nominal P ≤.003), and function (−3.6 to −4.9 points; all nominal P ≤.013).
Figure 2.
Changes in pain and function over time in the MTrP and control groups. Panels show the longitudinal changes from baseline to weeks 1, 2, 6, and 14 in (A) VAS knee pain, (B) WOMAC pain, (C) WOMAC stiffness, and (D) WOMAC function for the myofascial trigger point (MTrP) group and the control group. Points represent mean values, and error bars represent 95% confidence intervals. Higher scores indicate greater pain, stiffness, or functional impairment.
At week 14, the between-group differences were −0.74 points for VAS pain (95% CI, −1.17 to −0.31; P <0.001), −1.3 points for WOMAC pain (95% CI, −2.2 to −0.5; P =0.003), −0.8 points for WOMAC stiffness (95% CI, −1.1 to −0.4; P <0.001), and −4.9 points for WOMAC function (95% CI, −7.7 to −2.1; P <0.001) (Supplement 2 eTables 2 and 3).
Gait Outcomes
Gait trajectories are shown in Supplement 2 eFigure 1. In change-score comparisons, the MTrP-augmented group had greater increases in gait speed at weeks 1, 2, 6, and 14 (between-group differences, approximately 0.05–0.08 m/s; nominal P =0.001–0.044) (Table 3).
Table 3.
Changes in Gait Parameters Relative to Baseline at Different Time Points
| Outcome | Change within Groups, Mean (95% CI)a | Difference in Change Between Groups, Mean (95% CI)b | Cohen’s d | P value | |
|---|---|---|---|---|---|
| MTrP Group (n = 49) | Control Group (n = 48) | ||||
| Gait speed (m/s) | |||||
| 1 week post-treatment | 0.29 (0.25 to 0.33) | 0.23 (0.20 to 0.25) | 0.07 (0.02 to 0.11) | 0.55 | 0.008 |
| 2 weeks post-treatment | 0.36 (0.32 to 0.39) | 0.27 (0.24 to 0.31) | 0.08 (0.04 to 0.13) | 0.71 | 0.001 |
| 1 month post-treatment | 0.19 (0.16 to 0.22) | 0.14 (0.12 to 0.17) | 0.05 (0.00 to 0.09) | 0.41 | 0.044 |
| 3 months post-treatment | 0.11 (0.08 to 0.14) | 0.06 (0.03 to 0.09) | 0.05 (0.01 to 0.09) | 0.47 | 0.024 |
| Cadence (steps/min) | |||||
| 1 week post-treatment | 17.7 (14.9 to 20.6) | 14.4 (12.6 to 16.1) | 3.4 (−0.1 to 6.8) | 0.39 | 0.055 |
| 2 weeks post-treatment | 23.7 (20.5 to 26.9) | 19.5 (16.7 to 22.3) | 4.2 (−0.1 to 8.4) | 0.39 | 0.058 |
| 1 month post-treatment | 11.9 (9.4 to 14.4) | 9.5 (7.8 to 11.3) | 2.4 (−0.7 to 5.4) | 0.32 | 0.125 |
| 3 months post-treatment | 5.9 (3.9 to 7.9) | 4.2 (2.6 to 5.9) | 1.7 (−1.0 to 4.4) | 0.26 | 0.212 |
| Single-leg support time (% gait cycle) | |||||
| 1 week post-treatment | 10.85 ± 4.12 | 10.65 ± 3.80 | 0.20 (−1.38 to 1.77) | 0.05 | 0.807 |
| 2 weeks post-treatment | 11.30 ± 7.39 | 11.20 ± 6.00 | 0.10 (−2.57 to 2.78) | 0.02 | 0.938 |
| 1 month post-treatment | 7.90 ± 4.65 | 7.83 ± 5.09 | 0.07 (−1.87 to 2.02) | 0.02 | 0.939 |
| 3 months post-treatment | 2.70 ± 4.94 | 1.98 ± 5.04 | 0.72 (−1.27 to 2.70) | 0.14 | 0.481 |
| Swing phase (% gait cycle) | |||||
| 1 week post-treatment | −10.85 ± 4.12 | −10.65 ± 3.80 | −0.20 (−1.77 to 1.38) | −0.05 | 0.807 |
| 2 weeks post-treatment | −11.30 ± 7.39 | −11.20 ± 6.00 | −0.10 (−2.78 to 2.57) | −0.02 | 0.938 |
| 1 month post-treatment | −7.90 ± 4.65 | −7.83 ± 5.09 | −0.07 (−2.02 to 1.87) | −0.02 | 0.939 |
| 3 months post-treatment | −2.70 ± 4.94 | −1.98 ± 5.04 | −0.72 (−2.70 to 1.27) | −0.14 | 0.481 |
| Sagittal initial contact angle (°) | |||||
| 1 week post-treatment | 4.79 ± 1.62 | 4.14 ± 1.38 | 0.65 (0.04 to 1.26) | 0.43 | 0.037 |
| 2 weeks post-treatment | 6.08 ± 1.69 | 5.61 ± 1.87 | 0.47 (−0.24 to 1.18) | 0.27 | 0.190 |
| 1 month post-treatment | 2.69 ± 1.75 | 2.44 ± 1.13 | 0.25 (−0.33 to 0.83) | 0.17 | 0.399 |
| 3 months post-treatment | 0.87 ± 1.46 | 0.73 ± 1.07 | 0.14 (−0.39 to 0.67) | 0.11 | 0.601 |
| Sagittal toe-off angle (°) | |||||
| 1 week post-treatment | 11.46 ± 4.52 | 10.18 ± 3.57 | 1.28 (−0.37 to 2.93) | 0.31 | 0.127 |
| 2 weeks post-treatment | 13.57 ± 5.59 | 12.28 ± 4.79 | 1.29 (−0.81 to 3.39) | 0.25 | 0.226 |
| 1 month post-treatment | 6.89 ± 3.78 | 6.00 ± 3.35 | 0.89 (−0.55 to 2.33) | 0.25 | 0.221 |
| 3 months post-treatment | 2.69 ± 2.88 | 1.92 ± 3.35 | 0.77 (−0.48 to 2.02) | 0.25 | 0.227 |
| Coronal initial varus angle (°) | |||||
| 1 week post-treatment | −5.70 ± 2.43 | −5.01 ± 2.18 | −0.69 (−1.62 to 0.24) | −0.30 | 0.144 |
| 2 weeks post-treatment | −7.32 ± 2.73 | −6.45 ± 2.64 | −0.87 (−1.96 to 0.22) | −0.32 | 0.114 |
| 1 month post-treatment | −3.61 ± 2.59 | −2.72 ± 1.72 | −0.89 (−1.78 to 0.00) | −0.40 | 0.051 |
| 3 months post-treatment | −2.09 ± 2.17 | −1.49 ± 1.99 | −0.60 (−1.44 to 0.24) | −0.29 | 0.158 |
| Coronal ground clearance (cm or %) | |||||
| 1 week post-treatment | 5.78 ± 2.36 | 5.13 ± 1.89 | 0.65 (−0.22 to 1.52) | 0.30 | 0.142 |
| 2 weeks post-treatment | 7.07 ± 3.20 | 6.38 ± 2.33 | 0.69 (−0.43 to 1.81) | 0.25 | 0.226 |
| 1 month post-treatment | 3.20 ± 2.16 | 2.82 ± 1.62 | 0.38 (−0.39 to 1.15) | 0.20 | 0.329 |
| 3 months post-treatment | 1.63 ± 1.65 | 1.15 ± 1.49 | 0.48 (−0.15 to 1.11) | 0.31 | 0.136 |
Notes: a All change values were calculated as follow-up value minus baseline value. Increases in gait speed, cadence, single-leg support time, and coronal ground clearance generally indicate improved gait performance, whereas a negative change in coronal initial varus angle indicates reduced varus alignment. b Between-group difference was calculated as the change in the MTrP group minus the change in the control group. For gait speed, cadence, single-leg support time, swing phase (absolute values), and coronal ground clearance, positive values generally indicate greater improvement in the MTrP group. For the coronal initial varus angle, a negative change indicates a reduction in varus alignment and thus greater improvement in the MTrP group.
Mixed-effects models also showed higher gait speed in the MTrP-augmented group at all follow-up assessments (between-group differences, 0.037–0.072 m/s; nominal P =0.021 to <0.001) and higher cadence (3.19–5.64 steps/min; all nominal P ≤.028) (Supplement 2 eTable 4). Single-leg support time was 1.79 to 2.43 percentage points higher, with corresponding reductions in swing-phase duration (nominal P =0.002–0.021) (Supplement 2 eTable 5). Model-based differences also favored the MTrP-augmented group for the sagittal initial-contact angle through week 6, the sagittal toe-off angle through week 14, the coronal initial varus angle at weeks 1 through 6, and ground clearance at weeks 1, 2, and 14 (Supplement 2 eTables 6 and 7).
Pressure Pain Threshold Outcomes
Peri-knee PPT increased over time at all 7 acupoints (time effect, all P <0.001) (Supplement 2 eTable 8 and eFigure 2). Group-by-time interactions were observed for Dubi, Neixiyan, Zusanli, Yanglingquan, Liangqiu, and Heding (all nominal P ≤.046), but not for Xuehai (P =0.214) (Supplement 2 eTable 8).
Model-estimated PPT values were higher in the MTrP-augmented group at all 7 sites at week 1, 5 sites at week 2, no sites at week 6, and 2 sites at week 14 (Supplement 2 eTable 9A). Within the MTrP-augmented group, mean MTrP-site PPT increased from 3.13 (SE, 0.14) at baseline to 7.53 (SE, 0.14) at week 6 and 7.19 (SE, 0.14) at week 14 (site-by-time interaction, P <0.001) (Supplement 2 eTable 9B and eFigure 3).
Change-score comparisons favored the MTrP-augmented group at 5 sites at week 1 and at Liangqiu at week 2, with no between-group differences at weeks 6 or 14 (Supplement 2 eTable 10).
Needling Pain and Treatment Acceptability
Needling pain was higher in the MTrP-augmented group after the first session and at weeks 1 and 2. The corresponding between-group differences were 0.97, 1.74, and 2.45 points, respectively (all nominal P <0.001) (Supplement 2 eTable 11 and eFigure 4).
Treatment acceptability was 100% in both groups after the first session and was similar at week 1 (81.6% vs 85.4%; P =0.819). At week 2, acceptability was lower in the MTrP-augmented group than in the conventional group (36.7% vs 72.9%; P <0.001) (Supplement 2 eTable 11 and eFigure 5).
Adverse Events
At least 1 adverse event was reported by 12.2% of participants (6/49) in the MTrP-augmented group and 10.4% (5/48) in the conventional group. Reported events included needling-site pain, bruising or hematoma, and minor bleeding. No serious adverse events or adverse event–related withdrawals occurred (Supplement 2 eTable 12).
Discussion
In this randomized clinical trial of patients with early- to mid-stage KOA, adding myofascial trigger point (MTrP)–targeted needling to conventional acupuncture did not significantly improve the prespecified week-2 composite responder rate. Exploratory secondary analyses suggested greater improvements in pain, WOMAC outcomes, gait speed, and selected PPT measures during the 14-week study period. However, these differences were accompanied by greater needling pain and substantially lower treatment acceptability at week 2. Post hoc analyses using more stringent responder definitions also showed no statistically significant between-group differences.
The primary finding should be considered in the context of the active comparator and the observed treatment response. The sample size calculation assumed an 18.7–percentage-point difference in responder rates, whereas the observed difference was 8.4 percentage points. The responder rate in the conventional acupuncture group reached 87.5%, leaving limited room for additional between-group separation. Conventional acupuncture itself may improve pain and function in KOA, although the magnitude and certainty of benefit vary across treatment regimens.27 The requirement for simultaneous improvement in pain and function may also have reduced sensitivity to smaller or component-specific differences.
The clinical importance of the exploratory secondary findings was uncertain. Between-group differences of 0.44 to 0.74 points for VAS pain and 3.6 to 4.9 points for WOMAC function were modest relative to commonly reported individual-level improvement thresholds in osteoarthritis.28,29 Such thresholds vary according to the instrument, population, clinical anchor, and analytic method and should not be applied directly to between-group mean differences. Gait-speed differences of approximately 0.05 to 0.08 m/s overlap the range proposed for a small meaningful change but remain below the approximately 0.10 m/s benchmark commonly used for a substantial change.30 These findings may therefore represent small incremental effects, but their importance to patients remains uncertain.
Previous studies of MTrP-directed treatment for KOA have reported inconsistent findings. A preliminary 3-group randomized trial suggested greater improvement with trigger-point acupuncture than with standard or sham acupuncture, but included only 30 participants.31 A subsequent systematic review and meta-analysis suggested potential benefits for pain and physical function, although the included studies were heterogeneous.14 More recent randomized trials have also differed: adding MTrP dry needling to physiotherapy improved pain and function in one study,32 whereas adding dry needling to exercise therapy did not provide additional benefit in another.33 Fu’s subcutaneous needling has also shown favorable effects on soft-tissue pain, although its technique differs substantially from that used in the present trial.34 These differences in comparators, treatment intensity, target selection, cointerventions, and outcome definitions may account for the variable findings. The present trial specifically evaluated the incremental effect of MTrP targeting beyond an active conventional acupuncture regimen.
Gait and PPT provided quantitative complements to patient-reported outcomes. Gait analysis can identify mobility impairment not fully captured by pain scales,17 and patients with mild KOA may exhibit reduced walking speed and altered stance, swing, and knee kinematics.35 Because no strengthening or resistance-training intervention was provided, the observed gait changes may primarily reflect reduced pain-related guarding and greater willingness to load the affected limb rather than increased muscle strength. Gait biomechanics are also influenced by joint structure, balance, motor control, and psychological factors.36 Given the number of gait outcomes and time points examined, these findings remain exploratory.
Peri-knee PPT increased in both groups, with group-by-time interactions at 6 of the 7 shared acupoints. Pain sensitization may contribute to KOA pain that is not fully explained by structural joint pathology.16 Nevertheless, PPT is a psychophysical measure dependent on participant perception and response. Moreover, PPT at the 3 individualized MTrP sites was measured only in the augmented group; therefore, the within-group increases at these sites cannot establish an MTrP-specific effect.
MTrP augmentation individualized a fixed meridian-based protocol by adding tender and mechanically sensitive treatment sites. Ashi points and MTrPs may overlap because both are identified partly through tenderness,11 while myofascial pain may coexist with articular pathology and contribute additional nociceptive input.37 Clinically identified MTrPs are characterized by focal tenderness within a palpable taut band and may reproduce local or referred pain.23 Targeting these sites may therefore address a myofascial component not fully covered by standardized acupoint selection.
Dry needling may influence local neuromuscular activity, peripheral nociceptive input, spinal processing, and supraspinal pain modulation.13 Experimental studies also suggest possible roles for tissue injury and repair,38 purinergic signaling,39 neural–immune interactions,40 and segmental or descending modulation.41 However, the present trial did not measure muscle tone, tissue perfusion, neural activity, inflammatory mediators, or other mechanistic intermediates. These pathways therefore remain possible explanations rather than demonstrated mediators of the observed outcomes.
The additional insertions into highly tender tissues increased the overall stimulation burden. The between-group difference in needling pain increased from 0.97 points after the first session to 2.45 points at week 2, while treatment acceptability at week 2 was 36.7% in the MTrP-augmented group and 72.9% in the conventional acupuncture group. Greater needling intensity has similarly been associated with increased procedural pain and reduced willingness to repeat treatment in myofascial pain.42 These findings indicate an important trade-off between potential incremental benefit and tolerability, particularly given the burden of completing 10 sessions within 2 weeks. For patients with poor tolerance, needle-free approaches such as acupressure or manual trigger-point release warrant further evaluation.43 Adverse events were mild and self-limited, consistent with the generally favorable safety profile of acupuncture when performed by trained practitioners,44 although the study was not powered to detect uncommon complications.
Several limitations should be acknowledged. Participants and practitioners could not be blinded, which may have influenced subjective outcomes. The augmented regimen included 3 additional insertions and therefore differed from conventional acupuncture in needle number, tissue exposure, and stimulation intensity; consequently, the effects of MTrP targeting cannot be separated from those of a greater treatment dose. Nine randomized participants without postbaseline data were excluded from the modified intention-to-treat analysis, although the conservative sensitivity analysis supported the same primary conclusion. Multiple secondary outcomes and time-specific comparisons were examined without comprehensive multiplicity adjustment. Interpretation of PPT was limited by the baseline imbalance at Liangqiu and the absence of control-group measurements at individualized MTrP sites. Finally, the single-center setting, use of experienced acupuncturists, and 14-week follow-up may limit generalizability and assessment of longer-term treatment durability.
Conclusions
Adding MTrP-targeted needling to conventional acupuncture did not significantly improve the prespecified week-2 composite responder rate; therefore, superiority for the primary outcome was not established. Exploratory secondary analyses suggested between-group differences in pain, function, mechanical pain sensitivity, and selected gait measures through week 14. These potential benefits were accompanied by greater needling pain and substantially lower short-term treatment acceptability. Adequately powered multicenter trials using treatment-dose-matched comparators are needed to confirm these findings, prespecify outcome hierarchies and multiplicity-control procedures, and determine whether any incremental benefit is clinically meaningful and sufficiently durable to justify the additional procedural burden.
Acknowledgments
The authors thank all study participants and the clinical and research staff who contributed to this trial.
Funding Statement
This study was supported by the National Natural Science Foundation of China (Grant No. 82374489); the NATCM Initiative for Strengthening TCM Evidence-Based Research (NATCM-STER); the Tianjin Graduate Education Reform Research Program (Grant No. TJYG25101); the Faculty Development Research Program of Tianjin University of Traditional Chinese Medicine (Grant No. Y-202608); the Teaching Development Research Program of Tianjin University of Traditional Chinese Medicine (Grant No. A26JF12); the Open Research Fund of the Institute of Orthopedics and Traumatology, Tianjin University of Traditional Chinese Medicine (Grant No. 2024GSZ03; project title: Mechanisms of Medical Tai Chi in Regulating the Cartilage Repair Microenvironment in Knee Osteoarthritis); the Innovation Team Development Program of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Grant No. 4042502041; project title: Inheritance and Innovation Team for the Prevention and Treatment of Knee Osteoarthritis With Traditional Chinese Medicine); and the Second Batch of the Tianjin Municipal Health High-Level Talent Program (Grant No. TJSJMYXYC-D2-028-2026).
Trial Registration
Chinese Clinical Trial Registry (ChiCTR): ChiCTR2300073707, prospectively registered on July 19, 2023. The registered trial execution period and participant recruitment period were from July 19, 2023, to June 30, 2024.
Trial Status
Recruitment and follow-up were completed at the time of manuscript submission.
Data Sharing Statement
Deidentified individual participant data and analytic code will be made available upon reasonable request to the corresponding author (Chao Zhang; zhangchao2004.love@163.com) for secondary analyses, including reanalysis of primary and secondary outcomes, subgroup analyses, and pooled or meta-analytic purposes. Supporting documents, including the protocol, statistical analysis plan, informed consent form, case report form, and analytic codebook, will also be available. Requests require a written proposal and execution of a data access agreement. No patient-identifiable data will be shared. Additional details regarding data availability and sharing procedures are provided in Supplement 3.
Patient Involvement Statement
Study participants were not involved in the design, conduct, interpretation, or translation of the current research.
Ethics Approval and Informed Consent
Ethical approval was obtained from the Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Approval No. TYLL2023[K]011). All participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and reported following CONSORT and STRICTA guidelines.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors declare funding support as listed above, but no other conflicts of interest related to this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Deidentified individual participant data and analytic code will be made available upon reasonable request to the corresponding author (Chao Zhang; zhangchao2004.love@163.com) for secondary analyses, including reanalysis of primary and secondary outcomes, subgroup analyses, and pooled or meta-analytic purposes. Supporting documents, including the protocol, statistical analysis plan, informed consent form, case report form, and analytic codebook, will also be available. Requests require a written proposal and execution of a data access agreement. No patient-identifiable data will be shared. Additional details regarding data availability and sharing procedures are provided in Supplement 3.