Clinical trial NCT00653081: Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
Official title: Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Shoulder Pain
Keywords: Shoulder pain
Supervised Exercises
Radial Shock Wave Therapy
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
Collaborators: name: South Eastern Area Health Service
name: University of Oslo
First posted: 2008-04-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.

Detailed description: Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.

Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).

The study is designed as a randomised, single blind clinical controlled study.

Eligibility criteria: Inclusion Criteria:

* Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
* Dysfunction or pain on abduction
* Had a normal passive glenohumeral range of movement
* Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
* Positive Hawkins-Kennedys test.

Exclusion Criteria:

* Shoulder pain bilateral (both shoulders required treatment)
* Earlier operated in affected shoulder
* Had multidirectional instability
* Had the cervical syndrome
* Rheumatoid arthritis
* Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
* Not able to understand spoken or written Norwegian
* Considerable emotional distress
* Needed anticoagulant medicine
* Being pregnant
* Had had Shock Wave Therapy or Supervised Exercises before.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Secondary outcomes:
measure: Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.
timeFrame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department for physical medicine and rehabilitation, Ullevaal University Hospital
Study officials:
affiliation: Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
name: Kaia Engebretsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011 Jan;91(1):37-47. doi: 10.2522/ptj.20090338. Epub 2010 Nov 18.
citation: Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Brox JI. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010 Sep 23;11:218. doi: 10.1186/1471-2474-11-218.
citation: Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, Brox JI. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009 Sep 15;339:b3360. doi: 10.1136/bmj.b3360.