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

B

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

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

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
  • The patients must not be in phase 1 (inflammation phase)
  • Diabetics may be included
  • MRI must be taken to exclude other reasons for stiffness

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

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

Trial contacts and locations

1

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Central trial contact

Ove K Austgulen, MD; Jannike Øyen, M Sc

Data sourced from clinicaltrials.gov

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