Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

Shoulder Impingement Syndrome Clinical Trial

Official title:

Conservative or Operative Treatment for the Shoulder Impingement Syndrome? A Randomized Controlled Trial of 140 Patients Followed Up for Two Years.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00349648
• Other study ID #: IMP-E9/2001-140
• Status: Active, not recruiting
• Phase: N/A
• First received: July 6, 2006
• Last updated: July 6, 2006
• Start date: March 2001
• Est. completion date: July 2006

Study information

• Verified date: July 2006
• Source: Central Hospital of Kanta-Hame
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Procedure:
• acromioplasty

Locations

Country	Name	City	State
Finland	Kanta-Häme Central Hospital	Hämeenlinna

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital of Kanta-Hame

Country where clinical trial is conducted

Finland, 

References & Publications (6)

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. Erratum in: BMJ 1993 Nov 13;307(6914):1269. — View Citation

Green S, Buchbinder R, Glazier R, Forbes A. Interventions for shoulder pain. Cochrane Database Syst Rev. 2000;(2):CD001156. Review. Update in: Cochrane Database Syst Rev. 2006;(4):CD001156. — View Citation

Haahr JP, Østergaard 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. — View 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. — View 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. — View Citation

Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization
Secondary	pain at night
Secondary	disability
Secondary	ability to work
Secondary	ranges of motion
Secondary	cost-effectiveness