Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00633451
Status:
COMPLETED
Last Update Posted:
2013-03-28
First Post:
2008-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2008-03-04', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder disability and pain', 'timeFrame': '6 weeks and 3, 6,12 months'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['shoulder pain', 'shoulder impingement syndrome', 'manual therapy', 'rehabilitation'], 'conditions': ['Shoulder Impingement Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.proaxistherapy.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms associated with athletic activity (35% of patients)\n* Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:\n\n 1. Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test\n 2. Pain during active shoulder elevation at or above 60 degrees\n 3. Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation\n* Shoulder disability: 25/100 (0 = no disability)\n* Able to understand written and spoken\n\nExclusion Criteria:\n\n* Severe pain; pain is \\> 7/10 on NPRS (0 = no pain)\n* Shoulder surgery on affected shoulder\n* Traumatic shoulder dislocation within the past 3 months\n* Previous rehabilitation for this episode of shoulder pain\n* Reproduction of shoulder pain with active or passive cervical motion\n* Systemic inflammatory joint disease\n* Global loss of passive shoulder ROM, indicative of adhesive capsulitis\n* Full-thickness rotator cuff tear, as evidenced by any one of the following:\n\n 1. Markedly reduced shoulder external rotation strength\n 2. Drop arm test\n 3. External rotation lag sign\n 4. Lift off test\n 5. Positive findings on MRI or ultrasonography'}, 'identificationModule': {'nctId': 'NCT00633451', 'briefTitle': 'Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Proaxis Therapy'}, 'officialTitle': 'Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only', 'orgStudyIdInfo': {'id': '07-173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Manual Therapy + Exercise', 'interventionNames': ['Other: Manual Therapy and Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Exercise Only', 'interventionNames': ['Other: Exercise Only']}], 'interventions': [{'name': 'Manual Therapy and Exercise', 'type': 'OTHER', 'otherNames': ['Manual Therapy and Therapeutic Exercise'], 'description': '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.', 'armGroupLabels': ['1']}, {'name': 'Exercise Only', 'type': 'OTHER', 'otherNames': ['Therapeutic Exercise'], 'description': 'A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Proaxis Therapy', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Charles A Thigpen, PhD, PT, ATC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Florida'}, {'name': 'Lori A Michener, PhD, PT, ATC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}, {'name': 'Phil McClure, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arcadia University'}, {'name': 'Angela R Tate, PhD, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcadia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proaxis Therapy', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, {'name': 'Arcadia University', 'class': 'OTHER'}, {'name': "National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Scientist', 'investigatorFullName': 'Chuck Thigpen', 'investigatorAffiliation': 'Proaxis Therapy'}}}}