Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?

Bergen Surgical Hospital

Status: Unknown

Conditions: Adhesive Capsulitis

Treatments: Procedure: Arthroscopic capsular release; Procedure: Distention with steroid

Study type: Interventional

Funder types: Other

Identifiers

NCT01029600

2009/870

Details and patient eligibility

About

The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.

Full description

Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up

2. The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder.

   • External rotation 20 degrees or less
   • Abduction 45 degrees or less

3. The patients must not be in phase 1 (inflammation phase)

4. Diabetics may be included

5. MRI must be taken to exclude other reasons for stiffness

Exclusion criteria

1. Other reasons for stiffness( cuff rupture, arthritis)
2. Posttraumatic or postoperative stiffness
3. Patients not suited for day surgery
4. Patients with a history of subacromial impingement before developing stiffness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Arthroscopic Capsulotomy

Active Comparator group

Description:

Arthroscopic capsular release

Treatment:

Procedure: Arthroscopic capsular release

Distention with steroid

Active Comparator group

Description:

Arthrographic distention with contrast, saline, steroid and local anaesthetic

Treatment:

Procedure: Distention with steroid