Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain - Full Text View

Sponsored by:	Franklin Pierce University
Information provided by:	Franklin Pierce University
ClinicalTrials.gov Identifier:	NCT00797368

Purpose

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.

Condition	Intervention
Ankle Sprain	Other: Manual Therapy and Exercise Other: Home exercises

MedlinePlus related topics: Exercise and Physical Fitness

Drug Information available for: Calcium polystyrene sulfonate Polystyrene sulfonic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial

Further study details as provided by Franklin Pierce University:

Primary Outcome Measures:

Foot and Ankle Ability Measure [ Time Frame: 4-weeks and 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Numeric Pain Rating Scale [ Time Frame: 4-weeks and 6-months ] [ Designated as safety issue: No ]

Estimated Enrollment:	78
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Manual Therapy and Exercise: Experimental Manual Therapy and Exercise	Other: Manual Therapy and Exercise Manual Therapy and Exercise
Home Exercise: Active Comparator Home Exercise	Other: Home exercises Home exercises

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797368

Contacts

Contact: Josh Cleland, PT, PhD

603.464.2175

joshcleland@comcast.net

Locations

United States, Colorado
Regis University	Recruiting
Denver, Colorado, United States, 80221
Contact: Mike Keirns, PT, PhD 303-458-4982 mkeirns@regis.edu
Colorado University	Not yet recruiting
Denver, Colorado, United States, 80221
Contact: Paul Mintken, PT paul.mintken@ucdenver.edu
United States, New Hampshire
Concord Hospital	Recruiting
Concord, New Hampshire, United States, 03301
Contact: Melanie Bieniek, PT 603-227-7000 mbieniek@crhc.org

Sponsors and Collaborators

Franklin Pierce University

More Information

Responsible Party:	Franklin Pierce University ( Josh Cleland, PT, PhD )
Study ID Numbers:	HIC0828
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797368
Health Authority:	United States: Institutional Review Board

Keywords provided by Franklin Pierce University:

ankle sprain
manual therapy
exercise
physical therapy
Patients who have sustained an inversion ankle sprain

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Sprains and Strains

ClinicalTrials.gov processed this record on January 15, 2009