Clinical trial NCT00888498: Ankle Manual Therapy for Ankle Sprains
Official title: Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Sprains and Strains
Keywords: Sprains and Strains
Ankle
Manual Therapies
Outcome Studies
Lead sponsor: University of the Pacific
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: American Physical Therapy Association
First posted: 2009-04-27
Enrollment: 189
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of using ankle manual therapy procedures on clinical outcomes in individuals with post-acute ankle sprains.

Detailed description: Ankle sprains can cause ankle joint stiffness. Ankle joint stiffness may be a cause of pain, disability, and repeated sprains. Physical therapists use many ways to treat ankle joints that do not move well. One way takes 1-2 seconds. Another way may take up to 1 minute. Both kinds of stretches seem to improve ankle flexibility. However, we do not know how well they work to improve pain and disability in individuals following ankle sprains. The purpose of this research is to find out which physical therapy treatments work best for people with ankle sprains. To start the study, subjects will be asked to fill out some forms that ask about their ankle problem. Subjects will receive an examination by a physical therapist that includes gentle movements of the feet and legs to test their flexibility, strength, and balance. Subjects will then be assigned to 1 of 3 treatments to be provided by a separate physical therapist. They will not get to choose their group. All 3 groups will receive ankle stretching by the physical therapist. The groups will differ in how much and how fast the stretch will be. The first group will have an ankle stretch that lasts 1-2 seconds. The second group will have a stretch that lasts 1 minute. The third group will have their foot held without any stretching. After stretching, all subjects will receive the same kind of exercise program. Study-related treatment will last 5 sessions over 4 weeks, with 2 sessions for stretching within the 1st week and 1 session per week for the 3 following weeks for the exercise program. After 1 week and 4 weeks, subjects will fill out the same forms as at the initial examination. The treatment part of the study will then be finished. After 6 months, 1 year, and 2 years from enrollment in the study, subjects be asked to fill out many of the same forms that ask about their ankle problem. We think subjects that get a stretch will have a better outcome than subjects that get ankle holding. To test our idea, we will compare how subjects in each group tell us they are doing with their ankle problem on the Foot and Ankle Ability Measure at 1 week, 4 weeks, 6 months, 1 year, and 2 years following entry into the study. Since the way a person thinks and feels about their injury may have something to do with how much they improve during physical therapy, we will also measure these factors to find out if they affect the results of this study.

Eligibility criteria: Inclusion Criteria:

* Age 16-60 years
* Onset of ankle sprain at least 2 weeks prior to enrollment
* Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80%

Exclusion Criteria:

* Current status of assisted ambulation (eg, use of cane or crutches)
* Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular
* Positive anterior drawer or talar tilt dimple test
* Volume of the affected limb greater than 10% of the unaffected limb
* Previous history of ligament or bony reconstructive surgery to the ankle and foot
* Concomitant injury to other lower extremity joints

Primary outcomes:
measure: Foot and Ankle Ability Measure
timeFrame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Secondary outcomes:
measure: Patient Global Rating of Improvement
timeFrame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
measure: Modified Fear Avoidance Beliefs Questionnaire
timeFrame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
measure: Lower Extremity Self Efficacy Scale
timeFrame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
measure: Positive and Negative Affect Scale
timeFrame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Stockton
country: United States
facility: University of the Pacific
state: California
Study officials:
affiliation: University of the Pacific
name: Todd E Davenport, PT, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Kornelia Kulig, PhD, PT
role: STUDY_DIRECTOR
affiliation: University of Southern California
name: Beth Fisher, PhD, PT
role: STUDY_DIRECTOR
References:
citation: Davenport TE, Kulig K, Fisher BE. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial. BMC Complement Altern Med. 2010 Oct 19;10:59. doi: 10.1186/1472-6882-10-59.