Effectiveness of a Knee Isometric Program on Reducing Anterior Knee Pain and Improving Functional Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Knee Function
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline [CPG] - Academy of Orthopedic Physical Therapy).
Detailed Description
Participants will be randomly allocated into the KIP or control intervention via spreadsheet randomization algorithm at the time of consenting. Each patient will have equivalent experiences for the duration of the study regardless of allocation. Time spent with the physical therapist, daily length of exercise program, outcome measures recorded, and home education materials will all be similar for each group. Participants will be asked to refrain from any outside forms of lower extremity strengthening or training. Usage of pain medication (including over-the-counter and prescription drugs) will be documented in the pain journal. Proper use of the pain journal will be explained during consent and again at the initial intake session.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Accept all provisions of the study and agree to complete the program in its entirety
- •Age between 18-65
- •Complaint of anterior knee pain for at least 4 weeks, but no more than 12 months
- •Prescribed referral for physical therapy for their knee(s) from one of the investigators
Exclusion Criteria
- •Potential participant does not agree to comply with study protocols or does not wish to be subjected to a random group allocation
- •Any neurological or degenerative musculoskeletal condition involving the lower extremities
- •Ages outside of 18-65
- •Surgical history or fracture within the last 12 months on the affected extremity(ies)
- •Currently participating in a structured strength training program
- •Inability to access clinic for data collection or follow-up sessions
- •Significant anatomical anomaly or limb alignment disorder as diagnosed by medical professional (femoral anteversion/retroversion, patella alta/baja, varus/valgus deformities, patella deformities/fractures, osteotomy procedures, limb lengthening procedures)
- •Significant cartilage damage as diagnosed by medical professional (grade 3+ chondral defects of the femur or patella)
- •Any other condition that limits full weight bearing of the affected lower extremity(ies)
- •Vulnerable populations
Outcomes
Primary Outcomes
Knee Function
Time Frame: Baseline, 12 weeks
Participants will complete the lower extremity functional scale (LEFS) at session 1 and at session 5 (one month follow up visit after completing physical therapy) in order to determine any change in knee function across those time periods. The LEFS is a 20 question survey that asks about a person's ability to perform everyday tasks and each question is scored on a scale from 0 to 4 with 0 being extreme difficulty or unable to perform activity and 4 being no difficulty. These responses are then summed to get a total score out of 80 maximum points, and the lower the score, the greater the disability.
Functional Stability
Time Frame: Baseline, 12 weeks
Functional stability will be assessed at sessions 1 and 5 to determine each participant's dynamic balance, and it will be used to assess anterior reach specifically. This test has the participant stand on one leg while reaching out in 3 different directions with the other lower extremity, and thus measures strength, stability, and balance in multiple directions. The composite score is calculated by summing the three reach directions. Higher scores reflect better outcomes.
Objective Muscular Strength Performance
Time Frame: Baseline, 12 weeks
Participants will have their quad strength measured using a handheld dynamometer (HHD) at session 1 and session 5 of their study visits in order to determine with that data how muscular strength changes following each physical therapy regimen.
Subjective Pain
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks
Participants will complete the Numerical Pain Rating Scale (NPRS) in a pain and medication journal in order to subjectively rate their pain over over 4-5 days between each session, except for after session 4 in which they will document twice a day for 20 days. The NPRS rates pain on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable, and subjects will reflect pain pre and post physical therapy. Additionally, they will be asked to reflect any pain medication that they take on a given day.
Secondary Outcomes
No secondary outcomes reported
Investigators
Patrick McCulloch,MD
John S. Dunn Chair in Orthopedic Surgery
The Methodist Hospital Research Institute