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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
| Arcadia University | OTHER |
| National Athletic Trainers' Association Research & Education Foundation (NATA Foundation) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Manual Therapy + Exercise |
|
| 2 | Active Comparator | Exercise Only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy and Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder disability and pain | 6 weeks and 3, 6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Symptoms associated with athletic activity (35% of patients)
Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Charles A Thigpen, PhD, PT, ATC | University of North Florida | Principal Investigator |
| Lori A Michener, PhD, PT, ATC | Virginia Commonwealth University | Principal Investigator |
| Phil McClure, PhD, PT | Arcadia University | Principal Investigator |
| Angela R Tate, PhD, PT | Arcadia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proaxis Therapy | Greenville | South Carolina | 29607 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D015444 | Exercise |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Exercise Only | Other | A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function |
|
|
| D018771 |
| Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |