Clinical trial NCT06536426: Knee Isometric Program (KIP) Home Exercise Programs (HEP) Physical Therapy (PT) Study
Official title: Effectiveness of a Knee Isometric Program on Reducing Anterior Knee Pain and Improving Functional Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective Pain
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks
measure: Knee Function
timeFrame: Baseline, 12 weeks
measure: Objective Muscular Strength Performance
timeFrame: Baseline, 12 weeks
measure: Functional Stability
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
References: