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Operative or Conservative Treatment for Subacromial Impingement Syndrome?

NCT00428870 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2018-09-20

No results posted yet for this study

Summary

pShoulder 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, 24 months, 5 years and 10 years. Primary outcome measures are pain at rest and activity (VASs) and secondary outcomes are 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. At 10 year follow-up, MRI imaging is obtained and the findings compared to baseline imaging.

Conditions

  • Subacromial Impingement Syndrome

Interventions

PROCEDURE

Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Sponsors & Collaborators

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Mika Paavola, MD, PhD · 1.1.2003

  • Teppo Jarvinen, MD, PhD · 1.1.2004

  • Antti Malmivaara, MD, PhD · 1.8.2004

  • Timo Järvelä, MD, PhD · 1.1.2004

  • Simo Taimela, MD, PhD · 1.6.2004

  • Harri Sintonen, Professor · 1.8.2004

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428870 on ClinicalTrials.gov