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A total of 44 subjects were initially enrolled. One subject was subsequently excluded due to a concomitant diagnosis of frozen shoulder identified post-enrollment. Consequently, 43 subjects were included in the final analysis, comprising 6 subjects with unilateral pain and 37 subjects with bilateral pain, resulting in a total of 80 affected sides, with bilateral cases counted as two affected sides. The final distribution was 27 sides in the acupotomy group, 27 in the sham acupotomy group, and 26 in the blank control group. Randomization was performed centrally using a computer-generated 1:1:1 block sequence with variable block sizes of 4 or 6, and allocation was concealed using sealed opaque envelopes. For participants with bilateral pain, each affected side was randomized independently. No stratification was used. The sham acupotomy group received ultrasound-guided subcutaneous needling without fascial penetration, while the blank control group received no needle intervention and completed the same assessments at the corresponding time points. Patients were not blinded because of the difference in penetration depth between active and sham procedures, whereas outcome assessors and statisticians were blinded to group allocation.
All subjects diagnosed with trapezius myofascial pain syndrome had unilateral or bilateral active trigger points. No statistically significant differences were found among the three groups in baseline characteristics, including sex, age, and BMI, indicating comparability (see Table 1). The needle tip was clearly visualized at the superficial and deep fascial layers under ultrasound, and the operator perceived a distinct loss of resistance during release. Valid and stable biomechanical measurements, together with post-intervention changes in tissue stiffness and pain, indicated successful protocol execution. In a reliability assessment of 10 volunteers and 20 sides, inter-operator reliability was excellent (ICC = 0.970; SEM/MDC95 = 0.55/1.53), and intra-operator reliability was also excellent (ICC = 0.984; SEM/MDC95 = 0.41/1.15). Conversely, abnormal or unstable measurements suggest deviations in patient positioning, probe handling, or needle insertion, requiring repeated data acquisition or procedural adjustment in accordance with the quality control criteria of this protocol.
VAS scores, used to assess average pain intensity, were non-normally distributed and are presented as median (interquartile range). No significant differences in VAS scores were observed among the three groups at baseline (P > 0.05). Within-group comparisons revealed that in the acupotomy group, VAS scores at both 1 week and 2 weeks post-treatment were significantly lower than baseline (P < 0.001) and 0 week (immediately post treatment) (P < 0.001). No significant changes in VAS scores were observed at any time point within the sham acupotomy group or the blank control group (P > 0.05). Between-group comparisons demonstrated that VAS scores in the acupotomy group at 1 week and 2 weeks were significantly lower than those in both the sham group and the blank control group (P < 0.001 for all comparisons) (see Table 2 and Figure 3A).
SWE was employed to assess tissue stiffness, quantified as the shear modulus (G-value, in kPa), under both resting and passive stretching states. The G-value data for the acupotomy group followed a normal distribution and are presented as mean ± standard deviation. Data for the sham and control groups were non-normally distributed and are presented as median (interquartile range). Within-group comparisons in the acupotomy group showed that the resting-state G-value decreased significantly immediately post-treatment (0 week) compared to baseline (P < 0.01) and remained significantly lower than baseline at both 1-week and 2-week follow-ups (P < 0.05 for both). In the passive stretching state, a transient but significant increase in G-value was observed at 1 week compared to the 0-week measurement (P < 0.05), with no other significant changes compared to baseline. No significant within-group changes in G-value were observed at any time point in either state for the sham or blank control groups (P > 0.05). Between-group comparisons at baseline revealed significant differences in G-values, indicating a lack of baseline comparability for this parameter (see Table 3 and Figure 3B,C).
Measurements were obtained using the digital palpation device, recording muscle tone (Hz), stiffness (N/m), and elasticity (Logarithmic Decrement) under both resting and passive stretching states. Data conforming to a normal distribution are presented as mean ± SD, and non-normally distributed data are presented as median (IQR). In the acupotomy group, muscle tone under both resting and stretching states was significantly lower at 1 and 2 weeks compared to 0 week (P < 0.05 or P < 0.01). Stiffness in both states also showed significant decreases at 1 and 2 weeks versus 0 week (P < 0.01 for resting state; P < 0.05 for stretching state). For elasticity, resting-state elasticity at 1 week was significantly lower than at 0 week (P < 0.05). By 2 weeks, elasticity in both resting and stretching states was significantly lower than at both 0 week and baseline (P < 0.01 for comparisons with 0 week; P < 0.05 for comparisons with baseline). In the sham acupotomy group, only stretching-state stiffness showed a transient, isolated increase at 1 week compared to baseline (P < 0.05). No other parameters changed significantly at any time point. The blank control group showed no significant changes in any parameter (tone, stiffness, elasticity) across all time points. Between-group comparisons showed significant baseline differences in muscle tone and stiffness, precluding direct comparability at baseline. Specifically, the acupotomy group exhibited significantly higher resting-state tone than both control groups (P < 0.05 or P < 0.01) and higher resting-state stiffness than the sham group (P < 0.05). Under the stretching state, the acupotomy group’s tone and stiffness were both significantly higher than those of the sham group (P < 0.05 for both). Baseline elasticity was comparable across all groups. At the 2-week follow-up, the acupotomy group’s elasticity in the stretching state was significantly lower than that of the blank control group (P < 0.05). No other statistically significant between-group differences were observed at other time points (see Table 4 and Figure 3D-I).
During the treatment period, two adverse events were reported in the acupotomy group, both of which were cases of vasovagal syncope (needle fainting) occurring after needle withdrawal. The patients were promptly assisted into a supine position with the head lowered and legs elevated to promote cerebral blood flow, leading to rapid symptom resolution. No other adverse events were reported among the remaining participants.

Figure 1. Materials and equipment used in the study. (A) Required materials for the procedure: disposable dressing change kit, disposable sterile medical gloves, povidone‑iodine solution, disposable acupotomy needles (size 0.6 mm x 40 mm), and sterile fenestrated drapes. (B) Shear wave elastography was performed using a portable ultrasound diagnostic system. (C) The digital palpation device for soft‑tissue tension measurement. Please click here to view a larger version of this figure.

Figure 2. Measurement positions, measurement points, and ultrasound anatomy of the trapezius fascia. (A) Resting position and measurement points; (B) Passive stretch position; (C) Measurement of shear modulus G at resting position. (D) Representative ultrasound image (B‑mode) of the trapezius muscle showing the SF (arrow) and DF (arrowhead). Abbreviations: SF = superficial fascia; DF = deep fascia. Please click here to view a larger version of this figure.

Figure 3. Comparisons of VAS, SWE, and soft tissue tension properties among the three groups at different time points. (A) VAS scores. (B) SWE values at resting position (kPa). (C) SWE values under passive stretch (kPa). (D) Resting tone (Hz). (E) Resting stiffness (N/m). (F) Resting elasticity. (G) Passive stretch tone (Hz). (H) Passive stretch stiffness (N/m). (I) Passive stretch elasticity. Timepoint “0 wk” indicates measurements taken immediately post-intervention. *P<0.05, **P<0.01, ***P<0.001 for within-group comparisons; #P < 0.05, ##P < 0.01, ###P<0.001 for between-group comparisons. Abbreviations: VAS= Visual Analog Scale; SWE = Shear wave elastography. Please click here to view a larger version of this figure.
| Group | Sex (Male/Female) | Age (years) | BMI(kg/m2) |
| Acupotomy Group (n=27) | 8-19 | 28.15 ± 7.21 | 20.71 ± 2.33 |
| Sham Acupotomy Group (n=27) | 6-21 | 27.37 ± 7.37 | 22.18 ± 3.15 |
| Blank Control Group (n=26) | 5-21 | 27.50 ± 7.48 | 22.16 ± 3.21 |
| Statistic value | χ2 = 0.8434 | F = 0.0864 | F = 2.2205 |
| P-value | 0.6559 | 0.9173 | 0.1155 |
Table 1: Comparison of baseline data among the three groups.
| Group | Baseline | 0 week | Week 1 | Week 2 |
Acupotomy Group
(n=27) | 4.00(3.00,5.00) | 3.00(3.00,4.00) | 2.00(1.00,3.00)*^sb | 2.00(1.00,2.00)*^sb |
Sham Acupotomy
Group (n=27) | 5.00(3.00,6.00) | – | 5.00(3.00,5.75) | 4.00(3.25,5.75) |
| Blank Control Group (n=26) | 4.00(3.00,6.00) | – | 4.00(3.00,6.00) | 4.50(3.00,6.00) |
| Data are presented as median (interquartile range). 0 week, immediately post-intervention. –, not applicable. *P < 0.001 vs. baseline within the same group; ^P < 0.001 vs. 0 wk within the same group; bP < 0.001 vs. the blank control group at the same time point; sP < 0.001 vs. the sham acupotomy group at the same time point. |
Table 2: Comparison of Visual Analog Scale scores among three groups before and after Intervention. Data are presented as median (interquartile range). 0 week, immediately post intervention. –, not applicable. *P < 0.001 vs. baseline within the same group; ^P < 0.001 vs. 0 week within the same group; bP < 0.001 vs. the blank control group at the same time point; sP < 0.001 vs. the sham acupotomy group at the same time point.
| Group | Time Point | SWE at Rest (kPa) | SWE at Passive Stretch (kPa) |
| Acupotomy Group (n=27) | Baseline | 10.79±4.78# | 11.86±4.83 |
| 0 wk | 7.01±2.99** | 9.75±3.23 |
| Week 1 | 8.46±3.01* | 12.42±4.70^ |
| Week 2 | 8.51±2.99* | 10.20±3.50 |
Sham Acupotomy Group
(n=27) | Baseline | 8.47(6.56, 10.40) | 9.88(7.37, 13.57)# |
| Week 1 | 8.73(6.95, 11. 11) | 11.20(8.98, 14.30) |
| Week 2 | 7.93(6.34, 11.62) | 8.92(6.90, 11.59) |
Blank Control Group
(n=26) | Baseline | 8.74(5.96,9.40) | 11.49(10.31, 17.04) |
| Week 1 | 7.82(5.81, 11.00) | 10.95(10.12, 13.70) |
| Week 2 | 9.88(7.18, 12. 12) | 10.80(6.91, 12.03) |
| Data are presented as mean ± SD (x̄± SD) or median (interquartile range). SWE, shear wave elastography (kPa). 0 wk, immediately post-intervention. *P < 0.05, **P < 0.01 vs. baseline within the same group; ^P < 0.05 vs. 0 wk within the same group; #P < 0.05 vs. the blank control group at the same time point. |
Table 3: Comparison of SWE values at different positions among the three groups before and after intervention. Data are presented as mean ± SD (x̄± SD) or median (interquartile range). SWE, shear wave elastography (kPa). 0 wk, immediately post-intervention. *P < 0.05, **P < 0.01 vs. baseline within the same group; ^P < 0.05 vs. 0 wk within the same group; #P < 0.05 vs. the blank control group at the same time point.
| Group | Time
Point | Tone (Hz) | Stiffness (N/m) | Elasticity |
| | Rest | Passive
Stretch | Rest | Passive
Stretch | Rest | Passive
Stretch |
AG
(n=27) | Baseline |
18.80±1.81ssb | 21.35±1.88s | 369.52±58.6
5s | 441.00(407.
25,486.75)s | 1.14±0.16 | 1.15±0.21 |
| 0 wk | 19.71±1.97 | 22.13±2.37 | 394.78±62.0
6 | 456.00(424.
00,491.50) | 1.16±0.11 | 1.15±0.19 |
| Week 1 | 18.21±1.52^^ | 20.67±1.59^ | 347.56±50.1
6^^ | 428.00(379.
50,462.25)^ | 1.08±0.16^ | 1.07±0.15 |
| Week 2 | 18.08±1.88^^ | 20.27±2.20^^ | 333.81±86.2
2^^ | 422.00(351.
50,474.75)^ | 1.04±0.16*^^ | 1.03±0.13*^^
b |
SAG
(n=27) | Baseline | 17.30(15.85,
18.48) | 19.80(19.10,
21.17) | 327.78±67.8
6 | 389.00(372.
50,431.50) | 1.11±0.13 | 1. 12(1.01, 1.
21) |
| Week 1 | 17.90(16.92,
19.95) | 20.90(19.65,
22.08) | 357.78±60.4
5 | 436.00(402.
25,472.50)* | 1.12±0.12 | 1.09(1.02, 1.
14) |
| Week 2 | 17.50(16.90,
18.30) | 20.00(19.45,
21.95) | 342.96±49.0
1 | 421.00(383.
75,477.50) | 1.09±0.14 | 1.08(0.99, 1.
19) |
BCG
(n=26) | Baseline | 17.63±1.66 | 19.95(18.80,
21.70) | 332.50(310.
00,357.00) | 416.42±69.2
0 | 1.09(1.01, 1.
20) | 1.10±0.11 |
| Week 1 | 17.62±1.70 | 19.85(18.60,
21.50) | 324.00(298.
00,354.00) | 413.38±65.6
0 | 1.07(0.97, 1.
13) | 1.08±0.13 |
| Week 2 | 17.85±2.03 | 19.65(18.30,
20.70) | 340.50(312.
00,363.00) | 405.19±47.5
8 | 1.08(1.02, 1.
22) | 1.11±0.15 |
| Data are presented as mean ± SD (x̄± SD) or median (interquartile range). AG: Acupotomy Group; SAG: Sham Acupotomy Group; BCG: Blank Control Group. 0 wk, immediately post-intervention. *P < 0.05 vs. baseline within the same group; ^P < 0.05, ^^P < 0.01 vs. 0 wk within the same group; bP < 0.05 vs. the blank control group at the same time point; sP < 0.05,ssP < 0.01 vs. the sham acupotomy group at the same time point. |
Table 4: Comparison of soft tissue tension values at different positions among the three groups before and after intervention. Data are presented as mean ± SD (x̄± SD) or median (interquartile range). AG: Acupotomy Group; SAG: Sham Acupotomy Group; BCG: Blank Control Group. 0 wk, immediately post-intervention. *P < 0.05 vs. baseline within the same group; ^P < 0.05, ^^P < 0.01 vs. 0 wk within the same group; bP < 0.05 vs. the blank control group at the same time point; sP < 0.05,ssP < 0.01 vs. the sham acupotomy group at the same time point.
| Problem | Possible Cause | Solution |
| Unstable SWE signals or invalid shear modulus (G-value) | Patient movement; excessive probe pressure; probe not parallel to muscle fibers | Ask the patient to rest quietly for 10 min before measurement; control probe pressure (skin indentation < 0.5 cm); align the probe parallel to trapezius muscle fibers |
| No “loss of resistance” during acupotomy release | Needle tip fails to reach the targeted fascial layer | Adjust needle angle under real-time ultrasound guidance; reconfirm the depth of superficial and deep fascia |
| Abnormally high biomechanical values under passive stretching | Head lateral flexion angle > 45°; patient’s voluntary muscle contraction | Control flexion angle at 30°–45° using a goniometer; stabilize the patient’s shoulder to avoid compensatory contraction |
| Unclear visualization of fascial layers | Non-standardized ultrasound parameters; insufficient sterile coupling gel | Reset ultrasound settings (17 MHz, THI on, focus at 1.5–2 cm); apply adequate sterile coupling gel between probe and sterile cover |
| Vasovagal reaction (dizziness, pallor) during procedure | Patient anxiety; insufficient preoperative rest | Provide psychological comfort; extend preoperative rest to 15 min; stop procedure and place patient in supine position with legs elevated |
Table 5: Troubleshooting table.