Clinical Trials Directory

Trials / Terminated

TerminatedNCT02854774

Neural Mechanisms of Muscle Control in Individuals With Knee Pain

Status
Terminated
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
4 (actual)
Sponsor
University of Southern California · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMuscle activation exercisesActivation of either muscles activating the knee or hip.

Timeline

Start date
2016-08-30
Primary completion
2016-11-11
Completion
2016-11-11
First posted
2016-08-03
Last updated
2020-05-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02854774. Inclusion in this directory is not an endorsement.