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Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00633451
Enrollment
109
Registered
2008-03-12
Start date
2008-02-29
Completion date
2012-09-30
Last updated
2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation

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.

Interventions

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.

A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function

Sponsors

Virginia Commonwealth University
CollaboratorOTHER
Arcadia University
CollaboratorOTHER
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
CollaboratorOTHER
Proaxis Therapy
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Shoulder disability and pain6 weeks and 3, 6,12 months

Secondary

MeasureTime frame
Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication6 weeks, and 3, 6, 12 months
Patient perceived global rating of effect6 weeks and 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026