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

Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01029600

Enrollment

100

Registered

2009-12-10

Start date

2009-12-31

Completion date

2012-04-30

Last updated

2009-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

Randomized study capsulotomy vs distention with steroid

Brief summary

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

Detailed description

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

Interventions

PROCEDUREArthroscopic capsular release

Surgical division of thickened capsule in the shoulder

PROCEDUREDistention with steroid

Intraarticular distention with steroid, saline, contrast and local anaesthetic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Shoulder Function	2 years

Secondary

Measure	Time frame
Shoulder range of motion	2 years

Countries

Norway

Contacts

Primary ContactOve K Austgulen, MD

ovaust@gmail.com+4793232026

Backup ContactJannike Øyen, M Sc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026