Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS

Ullevaal University Hospital

Status and phase: Unknown; Phase 3

Conditions: Shoulder Pain

Treatments: Procedure: Radial Extracorporeal Shockwave Therapy; Procedure: Physical therapy method called Supervised Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT00653081

rESWT

VT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

A

Active Comparator group

Description:

Supervised Exercises performed at ulleval Hospital for patients with shoulder pain. Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks

Treatment:

Procedure: Physical therapy method called Supervised Exercises

B

Active Comparator group

Description:

Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

Treatment:

Procedure: Radial Extracorporeal Shockwave Therapy