Neural Mechanisms of Muscle Control in Individuals With Knee Pain

Early Phase 1

Terminated

• Conditions: Patellofemoral Pain Syndrome
• Interventions: Behavioral: Muscle activation exercises

• Registration Number: NCT02854774
• Lead Sponsor: University of Southern California

Brief Summary

This is a randomized controlled trial of knee muscle versus hip muscle strengthening for Patellofemoral Pain Syndrome.

Detailed Description

Rationale: Two prior randomized controlled trials (RCT) have highlighted the importance of hip muscle activation and strengthening as a treatment strategy for patellofemoral pain (Khayambashi, 2014; Khayambashi, 2012). Here, we propose a pilot study to acquire preliminary data to power a larger study to reveal the neural mechanism underlying the effectiveness of this intervention to promote its evidence-based incorporation into clinical practice.

Intervention: 4 weeks of quadriceps muscle versus 4 weeks of hip strengthening exercises.

Purpose: To determine changes in brain functional connectivity related to pain reduction induced by the strengthening exercises.

Study population: Males and females with a history of unilateral knee pain.

Methodology: Functional magnetic resonance imaging (fMRI) will be used to quantify functional connectivity of brain regions related to hip muscle activation. Functional connectivity will be quantified before (pre) and after (post) 4 weeks of quadricep or hip muscle strengthening exercises.

Arms: As above, there are 2 arms. 4 weeks of quadriceps strengthening exercises (Arm 1) versus 4 weeks of hip strengthening exercises (Arm 2).

Outcomes: At the pre and post-intervention sessions in each participant, we will quantify the brain functional connectivity between hip muscle motor cortex and the 1) thalamus, 2) basal ganglia, and 3) insula, and 4) the periaqueductal gray. We will also quantify self-report of pain and biomechanical function of the knee and hip.

Follow-up: A six month follow-up is planned for this pilot study.

Analysis Plan and Statistics: Functional connectivity of hip muscle motor cortex will be extracted using standard statistical software for brain mapping. A repeated measures ANOVA will be used to assess change in functional connectivity in the hip and knee group. Pain decreases in the both groups will be quantified and reported.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-07-30
• Study First Posted: 2016-08-03
• Study Start: 2016-08-30
• Primary Completion: 2016-11-11
• Study Completion: 2016-11-11
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Pain located specifically around the patellofemoral articulation (vague or localized).
2. Readily reproducible pain (3 out of 10 on a visual analog scale) with at least 2 of the following functional activities commonly associated with PFP: stair ascent or descent, squatting, kneeling, prolonged sitting, or isometric quadriceps contraction.
3. Reports of pain greater than 3 months duration.

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Exclusion Criteria

1. Previous history of knee surgery.
2. History of traumatic patellar dislocation.
3. Neurological involvement that would influence gait.
4. Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knee muscle activation/strengthening	Muscle activation exercises	4 weeks of exercises focused on activation and strengthening of knee extensor muscles.
Hip muscle activation/strengthening	Muscle activation exercises	4 weeks of exercises focused on activation and strengthening of hip extensor muscles.

Primary Outcome Measures

Name	Time	Method
Pain reduction measured using a visual analog scale (VAS) for knee pain	4 weeks and 6 months	Compared to baseline

Secondary Outcome Measures

Name	Time	Method
Brain function measured using fMRI	4 weeks	Compared to baseline
Muscle activation assessed with electromyographic (EMG) recordings	4 weeks	Activation of knee and hip muscles
Knee kinematics assessed with 3-dimensional motion capture	4 weeks	Body movement during a jumping task

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States