Clinical trial NCT00632996: Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
Official title: Effectiveness of Rehabilitation for Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Impingement Syndrome
Keywords: shoulder pain
shoulder impingement syndrome
manual therapy
rehabilitation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
name: University of North Florida
name: Arcadia University
First posted: 2008-03-11
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to:

1. determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome;
2. determine which patients are likely to respond to this rehabilitation program and which patients are not likely to respond to this rehabilitation program

The hypotheses are:

1. the rehabilitation treatment program will result in significant changes in pain and quality of life
2. there will be items from the history and examination that will identify those patients who respond favorably and those who do not respond favorably to rehabilitation at 6 weeks, 3, 6 and 12 months.

Detailed description: Subacromial impingement syndrome (SAIS) is the most frequent cause of shoulder pain. A variety of non-surgical treatments have been advocated to correct the impairments associated with SAIS. Clinical trials support the use of therapeutic exercise and joint mobilizations to improve pain and functional disability associated with SAIS. However, not all patients in these trials had a favorable outcome. Moreover, the effect sizes in these trials were small to moderate. Thus the purposes of this study are to 1. determine the effect of a multi-modal rehabilitation program consisting of strengthening, stretching, manual therapy to the shoulder and spine, patient education, posture, and functional re-training; and 2. identify those patients who are and who are not likely to respond to rehabilitation at the start of care.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of shoulder impingement syndrome as evidence by all 5 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
  4. Shoulder disability: greater than or equal to 20/100 (0 = no disability)
  5. Able to understand written and spoken English

Exclusion Criteria:

* Severe pain; pain is \> or equal to 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

Primary outcomes:
measure: Shoulder disability
timeFrame: 6 week and 3, 6, 12 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks and 3, 6, 12 months
measure: Quality of life
timeFrame: 6 weeks and 3, 6, 12 months
measure: Pain with rest, normal activities, and strenuous activities
timeFrame: 6 weeks and 3, 6, 12 months
measure: Patient perceived global rating of effect
timeFrame: 6 weeks and 3 months
measure: Additional healthcare utilization and medication use
timeFrame: 6 weeks and 3, 6, 12 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Lori A Michener, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcadia University
name: Phillip W McClure, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcadia University
name: Angela R Tate, PhD, PT
role: STUDY_DIRECTOR
affiliation: Virginia Commonwealth University
name: Ian A Young, PT
role: STUDY_CHAIR
References:
citation: Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.