No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: a randomised controlled trial

Objective-To assess the efficacy of bipolar interferential electrotherapy ( ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft ti ssue shoulder disorders (SD). Methods-Randomised placebo control; led trial with a two by two factorial d esign plus an additional control group in 17 primary care physiotherapy pra ctices in the south of the Netherlands. Patients with shoulder pain and/or restricted shoulder mobility, because of a soft tissue impairment without u nderlying specific or generalised condition, were enrolled if they had not recovered after six sessions of exercise therapy in two weeks. They were ra ndomised to receive (1) active ET plus active US; (2) active ET plus dummy US; (3) dummy ET plus active US; (4) dummy ET plus dummy US; or (5) no adju vants. Additionally, they received a maximum of 12 sessions of exercise the rapy in six weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 mo nths later were blinded for treatment. Outcome measures: recovery, function al status, chief complaint, pain, clinical status, and range of motion. Results-After written informed consent 180 patients were randomised: both t he active treatments were given to 73 patients, both the dummy treatments t o 72 patients, and 35 patients received no adjuvants. Prognosis of groups a ppeared similar at baseline. Blinding was successfully maintained. At six w eeks seven patients (20%) without adjuvants reported very large improvement (including complete recovery), 17 (23%) and 16 (22%) with active and dummy ET, and 19 (26%) and 14 (19%) with active and dummy US. These proportions increased to about 40% at three months, but remained virtually stable there after. Up to 12 months follow up the 95% CI for differences between groups for all outcomes include zero. Conclusion-Neither ET nor US prove to be effective as adjuvants to exercise therapy for soft tissue SD.