Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-28 @ 8:25 PM
Study NCT ID:
NCT00797368
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2008-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-08', 'studyFirstSubmitDate': '2008-11-24', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot and Ankle Ability Measure', 'timeFrame': '4-weeks and 6-months'}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Rating Scale', 'timeFrame': '4-weeks and 6-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ankle sprain', 'manual therapy', 'exercise', 'physical therapy', 'Patients who have sustained an inversion ankle sprain'], 'conditions': ['Ankle Sprain']}, 'referencesModule': {'references': [{'pmid': '23628755', 'type': 'DERIVED', 'citation': 'Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'A recent study has demonstrated that a physical therapist directed exercise program did not result in greater reductions in disability and pain when compared to a home exercise program. However, no manual therapy procedures were incorporated into the physical therapy treatment program despite recent evidence suggesting that thrust and non-thrust manual therapy techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the purpose of this study is to compare the effectiveness of a physical therapy management approach consisting of manual therapy and exercise to a home program of exercise only. The investigators hypothesize that the group receiving manual therapy and exercise will have better outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion/Exclusion Criteria:\n\n* A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility according to each inclusion/exclusion criterion.\n* The following inclusion criteria will be used to determine eligibility for this study:\n\n * Primary complaint of ankle pain, status post inversion ankle sprain.\n * The investigators decided to include patients with both acute and chronic ankle sprains since our previous work has shown that patients from both stage have exhibited positive benefits with manual therapy.66\n * Age between 16-60 years old\n * NPRS score \\> 3 points (average score) over past 24 hrs.\n * Does not meet criteria for needing radiographs per the Ottawa Ankle Rules\n* The following exclusion criteria will be used to determine ineligibility for this study:\n\n * Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, RA, osteoporosis, prolonged history of steroid use, severe vascular disease, etc.)\n * Prior surgery to the distal tibia, fibula, ankle joint, or rearfoot region (proximal to the base of the metatarsals).\n * Grade III ankle sprain (as defined by the West Point Ankle Sprain Grading System and/or tenderness along the anterior medial malleolus as described by,51 fracture, or other absolute contraindications to manual therapy.\n * Insufficient English language skills to complete all questionnaires\n * Inability to comply with treatment and follow-up schedule"}, 'identificationModule': {'nctId': 'NCT00797368', 'briefTitle': 'Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain', 'organization': {'class': 'OTHER', 'fullName': 'Franklin Pierce University'}, 'officialTitle': 'Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HIC0828'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual Therapy and Exercise', 'description': 'Manual Therapy and Exercise', 'interventionNames': ['Other: Manual Therapy and Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home Exercise', 'description': 'Home Exercise', 'interventionNames': ['Other: Home exercises']}], 'interventions': [{'name': 'Manual Therapy and Exercise', 'type': 'OTHER', 'description': 'Manual Therapy and Exercise', 'armGroupLabels': ['Manual Therapy and Exercise']}, {'name': 'Home exercises', 'type': 'OTHER', 'description': 'Home exercises', 'armGroupLabels': ['Home Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80221', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado University', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80221', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Regis University', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '03301', 'city': 'Concord', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Concord Hospital', 'geoPoint': {'lat': 43.20814, 'lon': -71.53757}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Franklin Pierce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joshua Cleland, DPT, OCS', 'investigatorAffiliation': 'Franklin Pierce University'}}}}