Viewing Study NCT00349648



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Study NCT ID: NCT00349648
Status: UNKNOWN
Last Update Posted: 2006-07-07
First Post: 2006-07-06

Brief Title: Conservative or Operative Treatment for the Shoulder Impingement Syndrome
Sponsor: Kanta-Häme Central Hospital
Organization: Kanta-Häme Central Hospital

Study Overview

Official Title: Conservative or Operative Treatment for the Shoulder Impingement Syndrome A Randomized Controlled Trial of 140 Patients Followed Up for Two Years
Status: UNKNOWN
Status Verified Date: 2006-07
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Study hypothesis The impingement syndrome of the rotator cuff is a common cause of shoulder pain for which the most effective treatment is unknown Steroid injections and anti-inflammatory analgetics are considered as effective methods Physiotherapy and acromioplasty are commonly used treatments

Hypothesis Arthroscopy and acromioplasty in addition to conservative treatment is equally effective as conservative treatment alone for shoulder impingement syndrome
Detailed Description: The aim of this study was to examine the effectiveness of arthroscopic acromioplasty in the treatment of the shoulder impingement syndrome Nonoperative treatment consisted of information given by a trained physiotherapist The patients were supervised with a progressive programme to improve the mobility and muscle strength of the shoulder region which was regularly controlled The exercises aimed at strengthening the stabilising muscles of the glenohumeral joint m trapezius m deltoides m supraspinatus and m infraspinatus and activating the decompressive muscles of the the subacromial space m teres major and minor m subscapularis The programme lasted for three months In addition the patients were given advice for daily home exercise

In the surgical group the patients underwent an arthroscopic examination and acromioplasty done by one experienced orthopaedic specialist Postoperatively the patients received similar physiotherapeutical information and training programme than in the conservative treatment group

The follow-up evaluations were performed at 3 6 and 12 months from the beginning of each treatment in addition at 24 months counted from the randomization A trained research physiotherapist who was blinded to the treatment group and had not been involved in their treatment performed a standardized assessment of all patients The range of motion muscle strengths and Neers tests were recorded At each evaluation the patients completed a structured questionnaire

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None