Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only
Manual Therapy and Exercise
+ Exercise Only
Shoulder Injuries+8
+ Joint Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: February 1, 2008
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.109 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location