Conservative or Operative Treatment for the Shoulder Impingement Syndrome?
Primary Purpose
Shoulder Impingement Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
acromioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring subacromial, impingement, acromioplasty, physiotherapy
Eligibility Criteria
Inclusion Criteria: a positive clinical Neer's test shoulder pain resistant to rest shoulder pain resistant to anti-inflammatory drugs shoulder pain resistant to subacromial steroid injections shoulder pain resistant to ordinary physiotherapy with a minimum history of three months Exclusion Criteria: glenohumeral or acromioclavicular arthritis glenohumeral instability total rupture of the rotator cuff cervical syndrome adhesive capsulitis neuropathy of the shoulder region
Sites / Locations
- Kanta-Häme Central Hospital
Outcomes
Primary Outcome Measures
shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization
Secondary Outcome Measures
pain at night
disability
ability to work
ranges of motion
cost-effectiveness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349648
Brief Title
Conservative or Operative Treatment for the Shoulder Impingement Syndrome?
Official Title
Conservative or Operative Treatment for the Shoulder Impingement Syndrome? A Randomized Controlled Trial of 140 Patients Followed Up for Two Years.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kanta-Häme Central Hospital
4. Oversight
5. Study Description
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 Neer´s tests were recorded. At each evaluation the patients completed a structured questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
subacromial, impingement, acromioplasty, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
acromioplasty
Primary Outcome Measure Information:
Title
shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization
Secondary Outcome Measure Information:
Title
pain at night
Title
disability
Title
ability to work
Title
ranges of motion
Title
cost-effectiveness
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a positive clinical Neer's test
shoulder pain resistant to rest
shoulder pain resistant to anti-inflammatory drugs
shoulder pain resistant to subacromial steroid injections
shoulder pain resistant to ordinary physiotherapy with a minimum history of three months
Exclusion Criteria:
glenohumeral or acromioclavicular arthritis
glenohumeral instability
total rupture of the rotator cuff
cervical syndrome
adhesive capsulitis
neuropathy of the shoulder region
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saara Ketola
Organizational Affiliation
Kanta-Häme Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanta-Häme Central Hospital
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
8241852
Citation
Brox JI, Staff PH, Ljunggren AE, Brevik JI. Arthroscopic surgery compared with supervised exercises in patients with rotator cuff disease (stage II impingement syndrome). BMJ. 1993 Oct 9;307(6909):899-903. doi: 10.1136/bmj.307.6909.899. Erratum In: BMJ 1993 Nov 13;307(6914):1269.
Results Reference
background
PubMed Identifier
10796418
Citation
Green S, Buchbinder R, Glazier R, Forbes A. Interventions for shoulder pain. Cochrane Database Syst Rev. 2000;(2):CD001156. doi: 10.1002/14651858.CD001156.
Results Reference
background
PubMed Identifier
15834056
Citation
Haahr JP, Ostergaard S, Dalsgaard J, Norup K, Frost P, Lausen S, Holm EA, Andersen JH. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis. 2005 May;64(5):760-4. doi: 10.1136/ard.2004.021188.
Results Reference
background
PubMed Identifier
8020202
Citation
Leroux JL, Codine P, Thomas E, Pocholle M, Mailhe D, Blotman F. Isokinetic evaluation of rotational strength in normal shoulders and shoulders with impingement syndrome. Clin Orthop Relat Res. 1994 Jul;(304):108-15.
Results Reference
background
PubMed Identifier
5054450
Citation
Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
Results Reference
background
PubMed Identifier
6825348
Citation
Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.
Results Reference
background
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Conservative or Operative Treatment for the Shoulder Impingement Syndrome?
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