Clinical trial NCT00633451: Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
Official title: Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: shoulder pain
shoulder impingement syndrome
manual therapy
rehabilitation
Lead sponsor: Proaxis Therapy
Sponsor class: INDUSTRY
Collaborators: name: Virginia Commonwealth University
name: Arcadia University
name: National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
First posted: 2008-03-12
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder disability and pain
timeFrame: 6 weeks and 3, 6,12 months
Secondary outcomes:
measure: Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication
timeFrame: 6 weeks, and 3, 6, 12 months
measure: Patient perceived global rating of effect
timeFrame: 6 weeks and 3 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Proaxis Therapy
state: South Carolina
Study officials:
affiliation: University of North Florida
name: Charles A Thigpen, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Lori A Michener, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcadia University
name: Phil McClure, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcadia University
name: Angela R Tate, PhD, PT
role: STUDY_DIRECTOR
References: