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Completed

NCT Number: NCT00797368

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

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.

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Key information

Conditions

Ankle Sprain Ankle Injuries Behavior Leg Injuries Motor Activity Wounds and Injuries

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado University, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Therapy and Exercise

Other

Manual Therapy and Exercise

Home Exercises

Other

Home exercises

Primary outcomes

  1. Foot and Ankle Ability Measure

    Time frame: 4-weeks and 6-months

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 4-weeks and 6-months

Sponsors and collaborators

Lead sponsor

Franklin Pierce University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2008
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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