Neural Mechanisms of Muscle Control in Individuals With Knee Pain

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Neural Mechanisms of Muscle Control in Individuals With Knee Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02854774
• Other study ID #: HS-16-00038
• Status: Terminated
• Phase: Early Phase 1
• Start date: August 30, 2016
• Est. completion date: November 11, 2016

Study information

• Verified date: April 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 11, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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).

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome

Intervention

Behavioral:
• Muscle activation exercises
Activation of either muscles activating the knee or hip.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.2013.1 — View 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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction measured using a visual analog scale (VAS) for knee pain	Compared to baseline	4 weeks and 6 months
Secondary	Brain function measured using fMRI	Compared to baseline	4 weeks
Secondary	Muscle activation assessed with electromyographic (EMG) recordings	Activation of knee and hip muscles	4 weeks
Secondary	Knee kinematics assessed with 3-dimensional motion capture	Body movement during a jumping task	4 weeks