Neural Mechanisms of Muscle Control in Individuals With Knee Pain
Primary Purpose
Patellofemoral Pain Syndrome
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Muscle activation exercises
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Pain located specifically around the patellofemoral articulation (vague or localized).
- 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.
- Reports of pain greater than 3 months duration.
Exclusion Criteria:
- Previous history of knee surgery.
- History of traumatic patellar dislocation.
- Neurological involvement that would influence gait.
- Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Knee muscle activation/strengthening
Hip muscle activation/strengthening
Arm Description
4 weeks of exercises focused on activation and strengthening of knee extensor muscles.
4 weeks of exercises focused on activation and strengthening of hip extensor muscles.
Outcomes
Primary Outcome Measures
Pain reduction measured using a visual analog scale (VAS) for knee pain
Compared to baseline
Secondary Outcome Measures
Brain function measured using fMRI
Compared to baseline
Muscle activation assessed with electromyographic (EMG) recordings
Activation of knee and hip muscles
Knee kinematics assessed with 3-dimensional motion capture
Body movement during a jumping task
Full Information
NCT ID
NCT02854774
First Posted
June 7, 2016
Last Updated
April 30, 2020
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02854774
Brief Title
Neural Mechanisms of Muscle Control in Individuals With Knee Pain
Official Title
Neural Mechanisms of Muscle Control in Individuals With Knee Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
No additional funding is available to continue this pilot study at this time.
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
November 11, 2016 (Actual)
Study Completion Date
November 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Knee muscle activation/strengthening
Arm Type
Active Comparator
Arm Description
4 weeks of exercises focused on activation and strengthening of knee extensor muscles.
Arm Title
Hip muscle activation/strengthening
Arm Type
Active Comparator
Arm Description
4 weeks of exercises focused on activation and strengthening of hip extensor muscles.
Intervention Type
Behavioral
Intervention Name(s)
Muscle activation exercises
Intervention Description
Activation of either muscles activating the knee or hip.
Primary Outcome Measure Information:
Title
Pain reduction measured using a visual analog scale (VAS) for knee pain
Description
Compared to baseline
Time Frame
4 weeks and 6 months
Secondary Outcome Measure Information:
Title
Brain function measured using fMRI
Description
Compared to baseline
Time Frame
4 weeks
Title
Muscle activation assessed with electromyographic (EMG) recordings
Description
Activation of knee and hip muscles
Time Frame
4 weeks
Title
Knee kinematics assessed with 3-dimensional motion capture
Description
Body movement during a jumping task
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain located specifically around the patellofemoral articulation (vague or localized).
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.
Reports of pain greater than 3 months duration.
Exclusion Criteria:
Previous history of knee surgery.
History of traumatic patellar dislocation.
Neurological involvement that would influence gait.
Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22027216
Citation
Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
Results Reference
result
PubMed Identifier
24440362
Citation
Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014 May;95(5):900-7. doi: 10.1016/j.apmr.2013.12.022. Epub 2014 Jan 16.
Results Reference
result
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Neural Mechanisms of Muscle Control in Individuals With Knee Pain
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