Skip to main content
OpenTrials
Completed

NCT Number: NCT00633451

Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Proaxis Therapy

Greenville, South Carolina, 29607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptoms associated with athletic activity (35% of patients)
  • Diagnosis of shoulder impingement syndrome as evidence by all 3 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: 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:
  • Markedly reduced shoulder external rotation strength
  • Drop arm test
  • External rotation lag sign
  • Lift off test
  • Positive findings on MRI or ultrasonography

Treatment and study plan

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.

Other names: Manual Therapy and Therapeutic Exercise

Exercise only

Other

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

Other names: Therapeutic Exercise

Primary outcomes

  1. Shoulder disability and pain

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

Secondary outcomes

  1. Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication

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

  2. Patient perceived global rating of effect

    Time frame: 6 weeks and 3 months

Sponsors and collaborators

Lead sponsor

Proaxis Therapy

Industry

Collaborators

  • Arcadia University
  • National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
  • Virginia Commonwealth University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2008
Registry last updated
Mar 28, 2013

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.

Published trials that share one or more normalized conditions with this study.