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

Ankle Sprain Clinical Trial

Official title:

Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain: A Multi-Center Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797368
• Other study ID #: HIC0828
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: July 8, 2013
• Start date: November 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Franklin Pierce University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Other:
• Manual Therapy and Exercise
Manual Therapy and Exercise
• Home exercises
Home exercises

Locations

Country	Name	City	State
United States	Concord Hospital	Concord	New Hampshire
United States	Colorado University	Denver	Colorado
United States	Regis University	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Pierce University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot and Ankle Ability Measure		4-weeks and 6-months	No
Secondary	Numeric Pain Rating Scale		4-weeks and 6-months	No