Dry Needling Plus Manual Therapy and Exercise for Subacromial Pain Syndrome: A Sham-Controlled Randomized Clinical Trial

OBJECTIVE: To determine the effect on shoulder pain and disability index (SPADI) scores of adding dry needling to a program of exercise and manual therapy in individuals with subacromial pain syndrome (SAPS). DESIGN: A three-arm randomized trial involving 121 participants with SAPS. METHODS: Participants were randomized to physical therapy treatment (PT Only), PT and sham dry needling (PT+SDN), or PT and dry needling (PT+DN) groups. The primary outcome was the SPADI at one year. Secondary measures included the Physical Function (PF) and Pain Interference (PI) subscales from the PROMIS-57, the Patient Acceptable Symptom State (PASS) and self-reported shoulder-related healthcare use. Linear marginal models and generalized estimating equations were used to identify differences between groups at each follow-up. Logistic regression was used to determine differences in healthcare use between groups at one-year. RESULTS: Differences [95% CI] in SPADI scores at one-year between the PT+DN and PT Only (-7.51[-16.57 - 1.54]), and the PT+DN and PT+SDN (-9.85, [-18.98 - 0.73]) groups did not reach statistical significance. Differences in the percentage of ‘Yes’ responses to the PASS were significant at six months between the PT+DN and PT-Only groups (34%, [14-55%]) and the PT+DN and PT+SDN groups (24% [4-45%]), and at one-year between the PT+DN and PT+SDN groups (28%, [7-49%]). Participants in the PT+DN group were less likely to receive additional care for their shoulder in the year following enrollment (OR=0.35, [0.13,0.95]). CONCLUSION: Adding dry needling to a standard physical therapy program did not result in greater improvements in SPADI scores at one year. Improvements in secondary outcomes and patient-perceived symptom acceptability may suggest potential clinical value.