Ankle Manual Therapy for Ankle Sprains

NCT ID: NCT00888498

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Sprains and Strains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hands-On Control

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the experimental groups. The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.

Group Type: PLACEBO_COMPARATOR

Passive Positioning

Intervention Type: OTHER

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the active comparator groups. The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.

Fast Stretching

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.

Group Type: EXPERIMENTAL

High-Velocity, Low-Amplitude Stretch

Intervention Type: OTHER

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.

Slow Stretching

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.

Group Type: EXPERIMENTAL

Slow, Mobilization Stretch

Intervention Type: OTHER

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.

Interventions

Passive Positioning

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the active comparator groups. The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.

Intervention Type: OTHER

High-Velocity, Low-Amplitude Stretch

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.

Intervention Type: OTHER

Slow, Mobilization Stretch

With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.

Intervention Type: OTHER

Other Intervention Names

Manual Therapy; Manual Therapy; Manual Therapy

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

American Physical Therapy Association

OTHER

Sponsor Role: collaborator

University of the Pacific

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd E Davenport, PT, DPT, OCS

Role: PRINCIPAL_INVESTIGATOR

University of the Pacific

Kornelia Kulig, PhD, PT

Role: STUDY_DIRECTOR

University of Southern California

Beth Fisher, PhD, PT

Role: STUDY_DIRECTOR

University of Southern California

Locations

University of the Pacific

Stockton, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20958995 (View on PubMed)

Other Identifiers

UPacific

Identifier Type: -

Identifier Source: org_study_id