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Trial NCT00797368

Resource URI: http://static.linkedct.org/resource/trials/NCT00797368
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/49366>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/52714>
linkedct:brief_title Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
linkedct:condition <http://static.linkedct.org/resource/condition/1005>
linkedct:criteria Inclusion/Exclusion Criteria: - 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. - The following inclusion criteria will be used to determine eligibility for this study: - Primary complaint of ankle pain, status post inversion ankle sprain. - 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 - Age between 16-60 years old - NPRS score > 3 points (average score) over past 24 hrs. - Does not meet criteria for needing radiographs per the Ottawa Ankle Rules - The following exclusion criteria will be used to determine ineligibility for this study: - 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.) - Prior surgery to the distal tibia, fibula, ankle joint, or rearfoot region (proximal to the base of the metatarsals). - 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. - Insufficient English language skills to complete all questionnaires - Inability to comply with treatment and follow-up schedule
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 60 Years
linkedct:eligibility_minimum_age 16 Years
linkedct:end_date June 2010
linkedct:enrollment 78 (xsd:int)
linkedct:firstreceived_date November 24, 2008
linkedct:has_dmc No
linkedct:id NCT00797368
linkedct:intervention <http://static.linkedct.org/resource/intervention/88118>
linkedct:intervention <http://static.linkedct.org/resource/intervention/95465>
rdfs:label Trial NCT00797368
linkedct:lastchanged_date November 24, 2008
linkedct:lead_sponsor_agency Franklin Pierce University
linkedct:location <http://static.linkedct.org/resource/location/149101>
linkedct:location <http://static.linkedct.org/resource/location/267303>
linkedct:location <http://static.linkedct.org/resource/location/311917>
linkedct:nct_id NCT00797368
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
linkedct:org_study_id HIC0828
linkedct:overall_contact_email joshcleland@comcast.net
linkedct:overall_contact_last_name Josh Cleland, PT, PhD
linkedct:overall_contact_phone 603.464.2175
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2938>
foaf:page <http://clinicaltrials.gov/show/NCT00797368>
linkedct:phase N/A
linkedct:primary_completion_date December 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/44262>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/72738>
linkedct:source Franklin Pierce University
linkedct:start_date November 2008
linkedct:study_design Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date November 2008