We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00349648
Recruitment Status : Unknown
Verified July 2006 by Central Hospital of Kanta-Hame.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2006
Last Update Posted : July 7, 2006
Sponsor:
Information provided by:

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
Shoulder Impingement Syndrome Procedure: acromioplasty

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)
Estimated 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
Estimated 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349648


Locations
Finland
Kanta-Häme Central Hospital
Hämeenlinna, Finland, 13530
Sponsors and Collaborators
Central Hospital of Kanta-Hame
Investigators
Principal Investigator: Saara Ketola Kanta-Häme Central Hospital
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00349648     History of Changes
Other Study ID Numbers: IMP-E9/2001-140
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: July 7, 2006
Last Verified: July 2006

Keywords provided by Central Hospital of Kanta-Hame:
subacromial
impingement
acromioplasty
physiotherapy

Additional relevant MeSH terms:
Syndrome
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases