Pain Clinical Trial
Official title:
Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain
Verified date | March 2024 |
Source | Keller Army Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this randomized control trial, participants with running-related knee pain will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a telehealth gait retraining intervention, an at-home exercise program, a return to running protocol, and standard physical therapy. Participants in the control group will receive an at-home exercise program, a return to running protocol, and standard physical therapy. Data will be collected before intervention, at 10-weeks, and at 14-weeks to determine efficacy of the intervention.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Active Duty Soldier or Cadet between the ages of 18 to 60 years old - Knee pain that occurs during and/or after running that was not due to a recent acute trauma (such as an accident or a fall) and that is a pain intensity of at least a '3' and no greater than a '7' on a numeric pain rating scale with '0' meaning "no pain" and '10' meaning the "worst possible pain" - Fluent in speaking and reading English Exclusion Criteria: - Currently on an Army running limiting profile for something other than knee pain - Presence of rheumatoid or neurological diseases - Plans to deploy or permanent change of station (PCS) within 4 months - Current lower extremity injury other than knee pain - History of traumatic knee injury (such as a surgery, ligament tear, or meniscal tear) - Current pregnancy - Inability to perform 20 unassisted single leg heel raises on each leg - A non-rearfoot strike pattern during running - Showing signs of ligamentous instability, meniscus pathology, or knee effusion |
Country | Name | City | State |
---|---|---|---|
United States | Keller Army Community Hospital - Arvin Physical Therapy | West Point | New York |
Lead Sponsor | Collaborator |
---|---|
Keller Army Community Hospital | Uniformed Services University of the Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks | |
Primary | Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks | |
Primary | Foot strike pattern during running measured with motion capture | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. | Change from baseline to 10-weeks | |
Secondary | University of Wisconsin Running Injury and Recovery Index | A 9-item questionnaire (range 0-36, higher scores indicate more function) that measures a runners assessment of running ability after sustaining a running-related injury. | Change from baseline to 10-weeks and 14-weeks | |
Secondary | Worst non-knee pain during running assessed by Visual Analogue Scale (VAS) | Worst pain intensity in a region other than the knee during running in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks and 14-weeks | |
Secondary | Worst knee pain overall assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity experienced overall in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks and 14-weeks | |
Secondary | Knee function assessed with the single assessment numeric evaluation method | Participants will rate their knee function on a scale of 0 (least normal) to 100 (most normal). | Change from baseline to 10-weeks and 14-weeks | |
Secondary | Knee function assessed with the anterior knee pain scale | Participants will rate their level of pain, disability, and impairment associated with their knee injury using a 13-item questionnaire (range 0-100, higher scores indicate better function). | Change from baseline to 10-weeks and 14-weeks | |
Secondary | Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 14-weeks | |
Secondary | Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 14-weeks | |
Secondary | Foot strike pattern during running measured with motion capture | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. | Change from baseline to 14-weeks |
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