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Completed

NCT Number: NCT00632996

Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of shoulder impingement syndrome as evidence by all 5 criteria:
  • Reproduction of symptoms with impingement test: either Hawkins-Kennedy or Neer Test
  • Pain during active shoulder elevation at or above 60 degrees
  • Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
  • Shoulder disability: greater than or equal to 20/100 (0 = no disability)
  • 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

Treatment and study plan

rehabilitation

Other

Exercise, manual therapy, patient education, posture, home exercise program

Other names: Physical Therapy, Manual Therapy

Primary outcomes

  1. Shoulder disability

    Time frame: 6 week and 3, 6, 12 months

Secondary outcomes

  1. Patient satisfaction

    Time frame: 6 weeks and 3, 6, 12 months

  2. Quality of life

    Time frame: 6 weeks and 3, 6, 12 months

  3. Pain with rest, normal activities, and strenuous activities

    Time frame: 6 weeks and 3, 6, 12 months

  4. Patient perceived global rating of effect

    Time frame: 6 weeks and 3 months

  5. Additional healthcare utilization and medication use

    Time frame: 6 weeks and 3, 6, 12 months

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Arcadia University
  • National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
  • University of North Florida

Registry information

Official study title

Effectiveness of Rehabilitation for Subacromial Impingement Syndrome

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2008
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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