Ankle Manual Therapy for Ankle Sprains

NCT00888498 | Suspended Phase 2

• 1 other identifier: UPacific
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Sprains and Strains

Keywords

Sprains and Strains; Ankle; Manual Therapies; Outcome Studies

Outcome Measures

Primary Outcomes (1)

• Foot and Ankle Ability Measure

  Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years

Secondary Outcomes (4)

• Patient Global Rating of Improvement

  Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years

• Modified Fear Avoidance Beliefs Questionnaire

  Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years

• Lower Extremity Self Efficacy Scale

  Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years

• Positive and Negative Affect Scale

  Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years

Study Arms (3)

Hands-On Control

PLACEBO COMPARATOR

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.

Other: Passive Positioning

Fast Stretching

EXPERIMENTAL

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.

Other: High-Velocity, Low-Amplitude Stretch

Slow Stretching

EXPERIMENTAL

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.

Other: Slow, Mobilization Stretch

Interventions

Passive Positioning 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.

Also known as: Manual Therapy

Hands-On Control

High-Velocity, Low-Amplitude Stretch 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.

Also known as: Manual Therapy

Fast Stretching

Slow, Mobilization Stretch 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.

Also known as: Manual Therapy

Slow Stretching

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Pacific: lead
• University of Southern California: collaborator
• American Physical Therapy Association: collaborator

Study Sites (1)

University of the Pacific

Stockton, California, 95219, United States

Location

Related Publications (1)

• 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.

  PMID: 20958995 DERIVED

MeSH Terms

Conditions

Sprains and Strains

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Todd E Davenport, PT, DPT, OCS

  University of the Pacific

  PRINCIPAL INVESTIGATOR

• Kornelia Kulig, PhD, PT

  University of Southern California

  STUDY DIRECTOR

• Beth Fisher, PhD, PT

  University of Southern California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 27, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-07

Locations

US (1)