Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
Manual Therapy and Exercise
+ Home exercises
Behavior+2
+ Leg Injuries
+ Motor Activity
Treatment Study
Summary
Study start date: November 1, 2008
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.74 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 16 to 60 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/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
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 3 locations
Regis University
Denver, United StatesConcord Hospital
Concord, United States