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

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy and Exercise
Home exercises
Sponsored by
Franklin Pierce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring ankle sprain, manual therapy, exercise, physical therapy, Patients who have sustained an inversion ankle sprain

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Colorado University
  • Regis University
  • Concord Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy and Exercise

Home Exercise

Arm Description

Manual Therapy and Exercise

Home Exercise

Outcomes

Primary Outcome Measures

Foot and Ankle Ability Measure

Secondary Outcome Measures

Numeric Pain Rating Scale

Full Information

First Posted
November 24, 2008
Last Updated
July 8, 2013
Sponsor
Franklin Pierce University
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1. Study Identification

Unique Protocol Identification Number
NCT00797368
Brief Title
Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Franklin Pierce University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
ankle sprain, manual therapy, exercise, physical therapy, Patients who have sustained an inversion ankle sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy and Exercise
Arm Type
Experimental
Arm Description
Manual Therapy and Exercise
Arm Title
Home Exercise
Arm Type
Active Comparator
Arm Description
Home Exercise
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Exercise
Intervention Description
Manual Therapy and Exercise
Intervention Type
Other
Intervention Name(s)
Home exercises
Intervention Description
Home exercises
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure
Time Frame
4-weeks and 6-months
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Time Frame
4-weeks and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Colorado University
City
Denver
State/Province
Colorado
ZIP/Postal Code
80221
Country
United States
Facility Name
Regis University
City
Denver
State/Province
Colorado
ZIP/Postal Code
80221
Country
United States
Facility Name
Concord Hospital
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23628755
Citation
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.
Results Reference
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Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain

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