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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00633451
Other study ID # 07-173
Secondary ID
Status Completed
Phase N/A
First received March 4, 2008
Last updated March 26, 2013
Start date February 2008
Est. completion date September 2012

Study information

Verified date March 2013
Source Proaxis Therapy
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Manual Therapy and Exercise
Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.
Exercise Only
A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function

Locations

Country Name City State
United States Proaxis Therapy Greenville South Carolina

Sponsors (4)

Lead Sponsor Collaborator
Proaxis Therapy Arcadia University, National Athletic Trainers’ Association Research & Education Foundation (NATA Foundation), Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder disability and pain 6 weeks and 3, 6,12 months No
Secondary Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication 6 weeks, and 3, 6, 12 months No
Secondary Patient perceived global rating of effect 6 weeks and 3 months No
See also
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Completed NCT04154345 - Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study N/A
Recruiting NCT05957952 - The Effects of Dynamic Taping With Exercise on Neuromuscular Control in Individuals With Subacromial Impingement N/A
Not yet recruiting NCT03554538 - Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain N/A
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