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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00797368
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Ankle Sprain Other: Manual Therapy and Exercise Other: Home exercises

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
Study Start Date : November 2008
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Manual Therapy and Exercise
Manual Therapy and Exercise
Other: Manual Therapy and Exercise
Manual Therapy and Exercise
Active Comparator: Home Exercise
Home Exercise
Other: Home exercises
Home exercises

Outcome Measures

Primary Outcome Measures :
  1. Foot and Ankle Ability Measure [ Time Frame: 4-weeks and 6-months ]

Secondary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: 4-weeks and 6-months ]

Eligibility Criteria

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797368

United States, Colorado
Colorado University
Denver, Colorado, United States, 80221
Regis University
Denver, Colorado, United States, 80221
United States, New Hampshire
Concord Hospital
Concord, New Hampshire, United States, 03301
Sponsors and Collaborators
Franklin Pierce University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joshua Cleland, DPT, OCS, Professor, Franklin Pierce University
ClinicalTrials.gov Identifier: NCT00797368     History of Changes
Other Study ID Numbers: HIC0828
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by Joshua Cleland, DPT, OCS, Franklin Pierce University:
ankle sprain
manual therapy
physical therapy
Patients who have sustained an inversion ankle sprain

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries