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

NCT ID: NCT00797368

Last Updated: 2013-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Manual Therapy and Exercise

Manual Therapy and Exercise

Group Type EXPERIMENTAL

Manual Therapy and Exercise

Intervention Type OTHER

Manual Therapy and Exercise

Home Exercise

Home Exercise

Group Type ACTIVE_COMPARATOR

Home exercises

Intervention Type OTHER

Home exercises

Interventions

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Manual Therapy and Exercise

Manual Therapy and Exercise

Intervention Type OTHER

Home exercises

Home exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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.

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Franklin Pierce University

OTHER

Sponsor Role lead

Responsible Party

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Joshua Cleland, DPT, OCS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Colorado University

Denver, Colorado, United States

Site Status

Regis University

Denver, Colorado, United States

Site Status

Concord Hospital

Concord, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23628755 (View on PubMed)

Other Identifiers

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HIC0828

Identifier Type: -

Identifier Source: org_study_id

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