Telemedicine, Running, Knee, Pain
Conditions
Brief summary
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.
Interventions
PROCEDURETelehealth Gait Retraining
Telehealth gait retraining is a novel approach to train participants to adopt a non-rearfoot foot strike pattern during running via telecommunications. During telehealth gait retraining, video of a participant's running form are sent to clinicians over a mobile device app and running form feedback is given. This process is repeated once a week for four weeks and then every other week until week 8.
PROCEDUREStandard Physical Therapy Treatment
Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.
PROCEDUREReturn to Running Protocol
The Return to Running protocol is a six-phase running volume progression to re-introduce running slowly and safely after experiencing a running-related injury.
PROCEDUREAt Home Exercise Program
The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.
Sponsors
Uniformed Services University of the Health Sciences
Keller Army Community Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Change from baseline to 10-weeks | 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. |
| Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Change from baseline to 10-weeks | 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. |
| Foot strike pattern during running measured with motion capture | Change from baseline to 10-weeks | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee function assessed with the single assessment numeric evaluation method | Change from baseline to 10-weeks and 14-weeks | Participants will rate their knee function on a scale of 0 (least normal) to 100 (most normal). |
| Knee function assessed with the anterior knee pain scale | Change from baseline to 10-weeks and 14-weeks | 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). |
| University of Wisconsin Running Injury and Recovery Index | Change from baseline to 10-weeks and 14-weeks | 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. |
| Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Change from baseline to 14-weeks | 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. |
| Foot strike pattern during running measured with motion capture | Change from baseline to 14-weeks | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. |
| Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Change from baseline to 14-weeks | 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. |
| Worst non-knee pain during running assessed by Visual Analogue Scale (VAS) | Change from baseline to 10-weeks and 14-weeks | 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. |
| Worst knee pain overall assessed by Visual Analogue Scale (VAS) | Change from baseline to 10-weeks and 14-weeks | 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. |
Countries
United States
Outcome results
None listed