Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

Not Applicable

Completed

• Conditions: Shoulder Impingement Syndrome
• Interventions: Other: Manual Therapy and Exercise; Other: Exercise Only

• Registration Number: NCT00633451
• Lead Sponsor: Proaxis Therapy

Brief Summary

The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.

Detailed Description

Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. However, the these clinical trials (3) have significant limitations and generalizability. Two of the three 3 trials had a small number of subjects (14 \& 22 subjects) and all 3 trials had only short term follow up (\<12 weeks) and used non-validated self report outcome measures. These limitations reduce the confidence with which clinicians can apply these results to the patients they treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. Therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with SAIS.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Symptoms associated with athletic activity (35% of patients)

• Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:

  1. Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test
  2. Pain during active shoulder elevation at or above 60 degrees
  3. Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation

• Shoulder disability: 25/100 (0 = no disability)

• Able to understand written and spoken

Exclusion Criteria

• Severe pain; pain is > 7/10 on NPRS (0 = no pain)

• Shoulder surgery on affected shoulder

• Traumatic shoulder dislocation within the past 3 months

• Previous rehabilitation for this episode of shoulder pain

• Reproduction of shoulder pain with active or passive cervical motion

• Systemic inflammatory joint disease

• Global loss of passive shoulder ROM, indicative of adhesive capsulitis

• Full-thickness rotator cuff tear, as evidenced by any one of the following:

  1. Markedly reduced shoulder external rotation strength
  2. Drop arm test
  3. External rotation lag sign
  4. Lift off test
  5. Positive findings on MRI or ultrasonography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Manual Therapy and Exercise	Manual Therapy + Exercise
2	Exercise Only	Exercise Only

Primary Outcome Measures

Name	Time	Method
Shoulder disability and pain	6 weeks and 3, 6,12 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication	6 weeks, and 3, 6, 12 months
Patient perceived global rating of effect	6 weeks and 3 months

Trial Locations

Locations (1)

Proaxis Therapy; 🇺🇸 Greenville, South Carolina, United States