Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Franklin Pierce University
- Enrollment
- 74
- Locations
- 6
- Primary Endpoint
- Foot and Ankle Ability Measure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Foot and Ankle Ability Measure
Time Frame: 4-weeks and 6-months
Secondary Outcomes
- Numeric Pain Rating Scale(4-weeks and 6-months)
Investigators
Joshua Cleland, DPT, OCS
Professor
Franklin Pierce University