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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
Sponsor:
Information provided by (Responsible Party):
Joshua Cleland, DPT, OCS, Franklin Pierce University

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE November 25, 2008
Last Update Posted Date July 9, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Foot and Ankle Ability Measure [ Time Frame: 4-weeks and 6-months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00797368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Numeric Pain Rating Scale [ Time Frame: 4-weeks and 6-months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
Official Title  ICMJE Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • Other: Manual Therapy and Exercise
    Manual Therapy and Exercise
  • Other: Home exercises
    Home exercises
Study Arms  ICMJE
  • Experimental: Manual Therapy and Exercise
    Manual Therapy and Exercise
    Intervention: Other: Manual Therapy and Exercise
  • Active Comparator: Home Exercise
    Home Exercise
    Intervention: Other: Home exercises
Publications * Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2013)
74
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2008)
78
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00797368
Other Study ID Numbers  ICMJE HIC0828
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joshua Cleland, DPT, OCS, Franklin Pierce University
Study Sponsor  ICMJE Franklin Pierce University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Franklin Pierce University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP