Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Effects of Music-Based Rhythmic Auditory Stimulation During Walking on Nociceptive Signaling and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Deepak Kumar, PT, PhD
- Phone Number: 617-358-3037
- Email: kumard@bu.edu
Study Contact Backup
- Name: Yiwen Yang, DPT
- Email: ywyang@bu.edu
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have activity related pain
- Experience morning knee stiffness ≤ 30 minutes
- Knee pain on most days for 3 months or more
- Able to walk at least 20 minutes with assistance
- Average overall knee pain severity of ≥= 4 on a 11-point numeric rating scale during previous week
- BMI ≤ 40
- Able to communicate using English at a level to understand the study procedures and informed consent
Exclusion Criteria:
- Contraindications to exercise
- Joint replacement in either hip, knee, or ankle
- History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors.
- Previous knee osteotomy in either knee
- Other health conditions that impact motor functioning or prevent participation (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc.)
- Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months
- Pregnancy (self-report)
- Suspected or known drugs or alcohol abuse
- Mini-mental State Examination (MMSE) score < 24
- Hearing impairments
- Pain in lower back or legs that is greater than knee pain
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Rhythmic auditory stimulation during walking
All participants will be exposed to different walking conditions including music, metronome, and no music or metronome
|
Walking to rhythmic Auditory Stimulation with music
walking to rhythmic Auditory Stimulation with metronome
Walking to no music or metronome
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise-Induced Hypoalgesia (EIH)
Time Frame: Baseline
|
Change in pressure pain threshold (PPT) from baseline to after each walking task
|
Baseline
|
|
medial quadriceps - medial hamstrings muscle coactivation
Time Frame: Baseline
|
Medial quadriceps-medial hamstrings muscle co-activation in each walking task will be assessed using surface electromyography
|
Baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medial quadriceps- medial gastrocnemius muscle coactivation
Time Frame: Baseline
|
Medial quadriceps-medial gastrocnemius muscle co-activation in each walking task will be assessed using surface electromyography
|
Baseline
|
|
lateral quadriceps- lateral hamstrings muscle coactivation
Time Frame: Baseline
|
Lateral quadriceps-lateral hamstrings muscle co-activation in each walking task will be assessed using surface electromyography
|
Baseline
|
|
lateral quadriceps - lateral gastrocnemius muscle coactivation
Time Frame: Baseline
|
Lateral quadriceps-lateral gastrocnemoius muscle co-activation in each walking task will be assessed using surface electromyography
|
Baseline
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Auditory-motor synchronization
Time Frame: Baseline
|
difference between actual cadence and target cadence in each walking ask (except walking to no music or metronome)
|
Baseline
|
|
physical activity enjoyment
Time Frame: Baseline
|
Modified Physical Activity Enjoyment Scale (PACES) score after each walking task.
Range is 7-49 with higher scores indicating greater enjoyment.
|
Baseline
|
|
Prefrontal cortex activation
Time Frame: Baseline
|
Prefrontal cortex (PFC) brain activation during each walking task will be assessed using functional near-infrared spectroscopy (fNIRS)
|
Baseline
|
|
Supplementary Motor Area activation
Time Frame: Baseline
|
Supplementary Motor Area (SMA) brain activation during each walking task will be assessed using functional near-infrared spectroscopy (fNIRS)
|
Baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Deepak Kumar, PT, PhD, Boston University Charles River Campus
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 8399
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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