Altering Knee Abduction Angular Impulse Using Wedged Insoles for Treatment of Patellofemoral Pain in Runners: A Six-Week Randomized Controlled Trial.

Objective: Determine if a change in internal knee abduction angular impulse (KAAI) is related to pain reduction for runners with patellofemoral pain (PFP) by comparing lateral and medial wedge insole interventions, and increased KAAI and decreased KAAI groups.

Design: Randomized controlled clinical trial (ClinicalTrials.gov ID# NCT01332110).

Setting: Biomechanics laboratory and community.

Patients: Thirty-six runners with physician-diagnosed PFP enrolled in the trial, and 27 were analyzed.

Interventions: Runners with PFP were randomly assigned to either an experimental 3 mm lateral wedge or control 6 mm medial wedge group. Participants completed a biomechanical gait analysis to quantify KAAIs with their assigned insole, and then used their assigned insole for six-weeks during their regular runs. Usual pain during running was measured at baseline and at six-week follow-up using a visual analog scale. Statistical tests were performed to identify differences between wedge types, differences between biomechanical response types (i.e. increase or decrease KAAI), as well as predictors of pain reduction.

Main Outcome Measures: Percent change in KAAI relative to neutral, and % change in pain over six weeks.

Results: Clinically meaningful reductions in pain (>33%) were measured for both footwear groups; however, no significant differences between footwear groups were found (p = 0.697). When participants were regrouped based on KAAI change (i.e., increase or decrease), again, no significant differences in pain reduction were noted (p = 0.146). Interestingly, when evaluating absolute change in KAAI, a significant relationship between absolute % change in KAAI and % pain reduction was observed (R2 = 0.21; p = 0.030), after adjusting for baseline pain levels.

Conclusion: The greater the absolute % change in KAAI during running, the greater the % reduction in pain over six weeks, regardless of wedge type, and whether KAAIs increased or decreased. Lateral and medial wedge insoles were similar in effectiveness for treatment of PFP.

Clinical Relevance: Altering KAAI should be a focus of future PFP research. Lateral wedges should be studied further as an alternative therapy to medial wedges for management of PFP.

Trial Registration: ClinicalTrials.gov NCT01332110.