Overview

This trial is active, not recruiting.

Condition subacromial impingement syndrome
Treatment arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
Phase phase 3
Sponsor Helsinki University
Start date October 2005
End date August 2015
Trial size 210 participants
Trial identifier NCT00428870, R04200

Summary

Shoulder impingement syndrome is common and number of operations done per year is growing. The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The results of treatment are measured at 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (VASs), functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change , quality of life assessment (SF-36 and 15D) and costs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Arthroscopic acromioplasty
arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
(Placebo Comparator)
Shoulder arthroscopy without active treatment and subacromial arthroscopy without bursectomy, decompression or other active interventions
arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
(Active Comparator)
Standardized exercise rehabilitation (supervised by physiotherapist)
arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Primary Outcomes

Measure
Pain at rest and activity assessed with 10-cm visual analog scales (VASs).
time frame: 2 years (primary)

Secondary Outcomes

Measure
Functional assessment of the shoulder with Constant score and Simple Shoulder test,
time frame: 2 years (primary)
global assessment of change,
time frame: 2 years (primary)
quality of life assessment (SF-36 and 15D),
time frame: 2 years (primary)
Costs
time frame: 2 years (primary)

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

Inclusion Criteria: In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfill the following inclusion criteria: 1. Subjects are 35 to 65 years of age female or male and have a characteristic history and symptoms of subacromial impingement syndrome at least 3 months. 2. Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection). 3. They have clinical findings of impingement syndrome; painful arc sign and pain in shoulder abduction, positive findings in two of three isometric shoulder abduction tests (0 degree, 30 degree and external rotation), and positive subacromial injection test. Exclusion Criteria: 1. Previous surgery of affected shoulder 2. Symptomatic osteoarthrosis of acromio-clavicular joint 3. Full thickness rotator cuff tear based on clinical findings and MRI 4. Long-term cervical syndrome 5. Instability of shoulder 6. Reluctance to participate in any study groups (i.e. any treatment options of the study) 7. Reduced co-operation (drug or alcohol abuse, mental illness)

Additional Information

Official title Arthroscopic Decompression Versus Diagnostic Arthroscopy Without Subacromial Decompression Versus Supervised Exercise Therapy in Treatment of Subacromial Impingement Syndrome. A Blinded Randomized Controlled Trail.
Principal investigator Mika Paavola, MD, PhD
Description Applicant information: Name: Mika Paavola, MD, PhD Address: Helsinki University Central Hospital, Töölö Hospital, Topeliuksenkatu 5, P.O. Box 266, FIN-00029 HUS, Finland Tel: +358 50 523 8382 Fax: +358 9 471 87481 Email: mika.paavola@hus.fi Trial record details: Protocol / serial number: N/A Title: Arthroscopic decompression versus diagnostic arthroscopy without subacromial decompression versus supervised exercise therapy in treatment of subacromial impingement syndrome. A blinded randomized controlled trail. Acronym: N/A Study hypothesis: Operative and diagnostic arthroscopy is equally effective as conservative treatment (supervised exercise therapy) alone for subacromial impingement syndrome. Research ethics review: Ethics committee approval from the Ethics Committee of the Hospital Districts of Pirkanmaa, date 28.12.2004 (ETL code R04200) Study design: Randomized controlled trial Participants - inclusion criteria: In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfill the following inclusion criteria: 1. Subjects are 35 to 65 years of age female or male and have a characteristic history and symptoms of subacromial impingement syndrome at least 3 months. 2. Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection). 3. They have clinical findings of impingement syndrome; painful arc sign and pain in shoulder abduction, positive findings in two of three isometric shoulder abduction tests (0 degree, 30 degree and external rotation), and positive subacromial injection test. Participants - exclusion criteria: 1. Previous surgery of affected shoulder 2. Symptomatic osteoarthrosis of acromio-clavicular joint 3. Full thickness rotator cuff tear based on clinical findings and MRI 4. Long-term cervical syndrome 5. Instability of shoulder 6. Reluctance to participate in any study groups (i.e. any treatment options of the study) 7. Reduced co-operation (drug or alcohol abuse, mental illness) Anticipated start date: 1/10/2005 Anticipated end date: 31/12/2009 Target number of participants: 210 Disease: Chronic (> 3 months before inclusion) shoulder subacromial pain syndrome. Interventions: The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The shoulder arthroscopy is done three to six week after the baseline clinical examination by one of the seven experienced shoulder orthopaedists. At first, arthroscopy of shoulder joint is performed in patients of acromioplasty group and control group, and all pathological findings are recorded. Thereafter, arthroscopy of subacromial space is carried out. In control group, subacromial decompression is not done. In patients of supervised exercised therapy group, 3 months period of exercise therapy with home exercises, supervised by experienced physiotherapist, is initiated. Primary outcome(s): Pain at rest and activity assessed with 10-cm visual analog scales (VASs). Participants assess maximum pain in the previous two days at rest and at exertion. Main follow-up time-point is 24 months after initiation of the treatment (i.e. operative treatment or first visit at the physiotherapist. Other time-points when the main outcome is measured are before the randomization, three month follow-up, six month follow-up and 12 month follow-up. Secondary outcome(s): Functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change [symptom questionnaire and subjective contentment (10-cm visual analog scales)], quality of life assessment (SF-36 and 15D). Sources of funding: Finnish Office for Health Technology Assessment (National Research and Development Centre for Welfare and Health of Finland) and Sigrid Juselius Foundation Main sponsor information Name: Finnish Office for Health Technology Assessment Address: National Research and Development Centre for Welfare and Health (STAKES) - P.O. Box 220, FI-00531 Helsinki, Lintulahdenkuja 4, Finland Contact person Contact information: Name: Mika Paavola Address: Department of Orthopedics and Traumatology, Töölö hospital, Helsinki University Central Hospital P.O. Box 266 00029 HUS Helsinki Finland Tel: +358-50-5238382 Email: mika.paavola@hus.fi and mika.paavola@fimnet.fi Privacy level: Show all contact details
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Helsinki University.