title: Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial.
abstract: BACKGROUND
  Subacromial shoulder pain is a common complaint. Radial Extracorporeal Shock Wave Therapy (rESWT) has being increasingly used to treat calcific and non-calcific tendinosis, although there is no evidence of the effectiveness of rESWT in non-calcific tendinosis of the rotator cuff. A randomised single blind study showed that the short-term effect of supervised exercises (SE) was significantly better than rESWT on subacromial shoulder pain, but both groups improved. In a clinical trial on achilles tendinopathy rESWT improved the effectiveness of treatment with eccentric loading. The objective of this present study is to evaluate if rESWT in addition to SE is more effective in improving shoulder pain and function compared with sham rESWT and SE in patients with subacromial shoulder pain.
  
  
  METHODS
  This is a double blind, randomised sham-controlled trial which is performed at the shoulder clinic at the Department of Physical Medicine and Rehabilitation in Oslo University Hospital, Norway. One-hundred-forty-four patients with subacromial shoulder pain lasting at least 3 months, age from 25 to 70 years old are included in the trial. Patients are randomly allocated in 1:1 ratio to receive either rESWT or sham rESWT once a week in addition to SE once a week for the initial 4 weeks. Subsequently SE are provided twice a week for 8 weeks. The primary outcome measure is a change in the Shoulder Pain and Disability Index (SPADI) at 24 weeks follow-up. Secondary outcomes include return to work, pain at rest and on activity, function, and health related quality of life. The patients, the physiotherapist providing the exercise regimen and the outcome assessor are blinded to group assignment. The physiotherapist providing the rESWT is not blinded.
  
  
  CONCLUSIONS
  Because of the extensive use of rESWT in the treatment of subacromial shoulder pain the results of this trial will be of importance and have impact on clinical practice.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01441830.
authors.affiliation: Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postboks 4956, Nydalen, 0424, Oslo, Norway. ekvalv@ous-hf.no.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Kvalvaag
authors.affiliation: Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postboks 4956, Nydalen, 0424, Oslo, Norway. jbrox@ous-hf.no.
authors.forename: Jens Ivar
authors.initials: JI
authors.lastname: Brox
authors.affiliation: Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postboks 4956, Nydalen, 0424, Oslo, Norway. uxaien@ous-hf.no.
authors.forename: Kaia Beck
authors.initials: KB
authors.lastname: Engebretsen
authors.affiliation: Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postboks 4956, Nydalen, 0424, Oslo, Norway. uxheob@ous-hf.no.
authors.forename: Helene Lundgaard
authors.initials: HL
authors.lastname: Søberg
authors.affiliation: Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postboks 4956, Nydalen, 0424, Oslo, Norway. uxerba@ous-hf.no.
authors.forename: Erik
authors.initials: E
authors.lastname: Bautz-Holter
authors.affiliation: Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postboks 4956, Nydalen, 0424, Oslo, Norway. ceroee@ous-hf.no.
authors.forename: Cecilie
authors.initials: C
authors.lastname: Røe
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D019220:High-Energy Shock Waves / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D020069:Shoulder Pain / Q000175:diagnosis* / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D010919:Placebos