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Intramuscular stimulation versus sham needling for the treatment of chronic midportion Achilles tendinopathy: a randomized controlled clinical trial
Solomons L, Lee JJY, Bruce M, White LD, Scott A
PLoS ONE 2020 Sep;15(9):e0238579
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The insertion of filiform needles intramuscularly (AKA intramuscular stimulation/dry needling) has been suggested as a possible treatment for various painful musculoskeletal conditions. Our aim was to answer the question, is intramuscular stimulation more effective than sham intramuscular stimulation/dry needling for the treatment of Achilles tendinopathy? METHODS: 52 participants with persistent midportion Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control) (n = 8). The a priori primary outcome measure was change in VISA-A score at 12 weeks-VISA-A was also measured at 6 weeks, and at 6 and 12 months. Secondary outcome measures include the proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm). RESULTS: The study retention was 94% at 12 weeks and 88% at 1 year. VISA-A score improved in all three groups over time (p < 0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean +/- SD: G3 59 +/- 13, G2 57 +/- 17, G1 56 +/- 22), at 12 weeks (G3 76 +/- 14, G2 76 +/- 15, G1 82 +/- 11) or at any other timepoint. The percentage of patients who rated themselves as much or very much improved (ie, treatment success) was not different after 12 weeks (G3 70%, G2 89%, G1 86% p = 0.94), or at 26 (p = 0.62) or 52 weeks (p = 0.71). No clinically significant effects of intervention group were observed in any of the secondary outcome measures. CONCLUSION: The addition of intramuscular stimulation to standard rehabilitation for Achilles tendinopathy did not result in any improvement over the expected clinical benefit achieved with exercise-based rehabilitation alone.

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