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

NCT00797368 | Completed

• 1 other identifier: HIC0828
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Ankle Sprain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Foot and Ankle Ability Measure

  4-weeks and 6-months

Secondary Outcomes (1)

• Numeric Pain Rating Scale

  4-weeks and 6-months

Study Arms (2)

Manual Therapy and Exercise

EXPERIMENTAL

Manual Therapy and Exercise

Other: Manual Therapy and Exercise

Home Exercise

ACTIVE COMPARATOR

Home Exercise

Other: Home exercises

Interventions

Manual Therapy and Exercise OTHER

Manual Therapy and Exercise

Manual Therapy and Exercise

Home exercises OTHER

Home exercises

Home Exercise

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Franklin Pierce University: lead

Study Sites (3)

Colorado University

Denver, Colorado, 80221, United States

Location

Regis University

Denver, Colorado, 80221, United States

Location

Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Related Publications (1)

• 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.

  PMID: 23628755 DERIVED

MeSH Terms

Conditions

Ankle Injuries; Motor Activity

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

US (3)