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Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

NCT ID: NCT00349648

Last Updated: 2006-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Shoulder Impingement Syndrome

Keywords

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subacromial impingement acromioplasty physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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acromioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanta-Häme Central Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Saara Ketola

Role: PRINCIPAL_INVESTIGATOR

Kanta-Häme Central Hospital

Locations

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Kanta-Häme Central Hospital

Hämeenlinna, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 8241852 (View on PubMed)

Green S, Buchbinder R, Glazier R, Forbes A. Interventions for shoulder pain. Cochrane Database Syst Rev. 2000;(2):CD001156. doi: 10.1002/14651858.CD001156.

Reference Type BACKGROUND
PMID: 10796418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15834056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8020202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5054450 (View on PubMed)

Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

Reference Type BACKGROUND
PMID: 6825348 (View on PubMed)

Other Identifiers

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IMP-E9/2001-140

Identifier Type: -

Identifier Source: org_study_id