Sprains and StrainsPhase 2/3AMTNCT00888498
Ankle Manual Therapy for Ankle Sprains
A Phase 2/3 study testing Passive Positioning, High-Velocity, Low-Amplitude Stretch and Slow, Mobilization Stretch in people with Sprains and Strains, run by University of the Pacific at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Sprains and Strains
- What is being tested?
- Passive Positioning, High-Velocity, Low-Amplitude Stretch and Slow, Mobilization Stretch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of the Pacific
Stockton, California, 95219
About this study
Official title: Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial
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.
Read the 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
- Being tested
- Passive Positioning, High-Velocity, Low-Amplitude Stretch, Slow, Mobilization Stretch
- Keywords
- Sprains and Strains, Ankle, Manual Therapies, Outcome Studies
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive PositioningOther
Also called Manual Therapy
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.
High-Velocity, Low-Amplitude StretchOther
Also called Manual Therapy
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, Mobilization StretchOther
Also called Manual Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Slow, Mobilization Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure
Measured: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Secondary outcomes (4)
Patient Global Rating of Improvement
Measured: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Modified Fear Avoidance Beliefs Questionnaire
Measured: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Lower Extremity Self Efficacy Scale
Measured: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Positive and Negative Affect Scale
Measured: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sprains and StrainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, American Physical Therapy Association
- Responsible party
- Sponsor
- Investigators
- Todd E Davenport, PT, DPT, OCS, Principal investigator, University of the PacificKornelia Kulig, PhD, PT, Study director, University of Southern CaliforniaBeth Fisher, PhD, PT, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888498
- Sponsor's protocol ID
- UPacific
- Acronym
- AMT
- Status last verified
- Jul 2015
- First submitted
- 24 Apr 2009
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20958995
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00888498
- Acronym / sponsor ID
- AMT / UPacific
- Conditions
- Sprains and Strains
- Keywords
- Sprains and Strains, Ankle, Manual Therapies, Outcome Studies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Collaborators
- University of Southern California, American Physical Therapy Association
- Study start
- Jan 2009
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hands-On Control | Placebo comparator | Other: Passive PositioningWith 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. |
| Fast Stretching | Experimental | Other: High-Velocity, Low-Amplitude StretchWith 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 | Experimental | Other: Slow, Mobilization StretchWith 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive PositioningAlso: Manual TherapyWith 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. | Other | Hands-On Control |
| High-Velocity, Low-Amplitude StretchAlso: Manual TherapyWith 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 | Fast Stretching |
| Slow, Mobilization StretchAlso: Manual TherapyWith 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 Stretching |
Primary outcome
Foot and Ankle Ability Measure
Time frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
4 secondary outcomes
Patient Global Rating of Improvement
Time frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Modified Fear Avoidance Beliefs Questionnaire
Time frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Lower Extremity Self Efficacy Scale
Time frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Positive and Negative Affect Scale
Time frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Derived from this study: PubMed 20958995Davenport 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd E Davenport, PT, DPT, OCS principal investigator
University of the Pacific
Kornelia Kulig, PhD, PT study director
University of Southern California
Beth Fisher, PhD, PT study director
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Passive Positioning, High-Velocity, Low-Amplitude Stretch and Slow, Mobilization Stretch in people with Sprains and Strains, run by University of the Pacific at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (time frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.