Clinical trial NCT00349648: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: subacromial
impingement
acromioplasty
physiotherapy
Lead sponsor: Kanta-Häme Central Hospital
Sponsor class: OTHER_GOV
First posted: 2006-07-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization
Secondary outcomes:
measure: pain at night
measure: disability
measure: ability to work
measure: ranges of motion
measure: cost-effectiveness
Other outcomes:
Locations:
city: Hämeenlinna
country: Finland
facility: Kanta-Häme Central Hospital
Study officials:
affiliation: Kanta-Häme Central Hospital
name: Saara Ketola
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.