Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

• ClinicalTrials.gov Identifier: NCT00349648
• Recruitment Status: Unknown
• First Posted: July 7, 2006
• Last Update Posted: July 7, 2006
• Sponsor: Kanta-Häme Central Hospital
• Information provided by: Kanta-Häme Central Hospital

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Impingement Syndrome	Procedure: acromioplasty	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Conservative or Operative Treatment for the Shoulder Impingement Syndrome? A Randomized Controlled Trial of 140 Patients Followed Up for Two Years.
• Study Start Date: March 2001
• Study Completion Date: July 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization

Secondary Outcome Measures :

1. pain at night
2. disability
3. ability to work
4. ranges of motion
5. cost-effectiveness

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Finland

Kanta-Häme Central Hospital

Hämeenlinna, Finland, 13530

Sponsors and Collaborators

Kanta-Häme Central Hospital

Investigators

• Principal Investigator: Saara Ketola; Kanta-Häme Central Hospital

More Information

Publications:

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.

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.

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.

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.

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.

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

• ClinicalTrials.gov Identifier: NCT00349648
• Other Study ID Numbers: IMP-E9/2001-140
• First Posted: July 7, 2006
• Last Update Posted: July 7, 2006
• Last Verified: July 2006

Keywords provided by Kanta-Häme Central Hospital:

subacromial; impingement; acromioplasty; physiotherapy

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries; Disease; Pathologic Processes; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases