The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain: a Double-blinded, Randomized, Sham-controlled, Mixed-methods, Pilot Trial with a Six-month Post-treatment Follow-up.

The Hong Kong Polytechnic University1 site in 1 country30 target enrollmentSeptember 20, 2024

ConditionsChronic Non-Specific Low Back Pain Chronic Knee Pain Chronic Musculoskeletal Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Non-Specific Low Back Pain
Sponsor: The Hong Kong Polytechnic University
Enrollment: 30
Locations: 1
Primary Endpoint: ITBS acceptability questionnaire
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to explore the effects of accelerated intermittent Theta Burst Stimulation (iTBS) on pain relief and cognitive function in older adults with chronic musculoskeletal pain. It will also utilize magnetic resonance imaging to illustrate the neurophysiological mechanisms underlying the role of iTBS in improving various outcome indicators in this population.

The main questions it aims to answer are:

Is left dorsolateral prefrontal cortex stimulation using accelerated iTBS effective for older adults with chronic musculoskeletal pain?
What are the neurophysiological mechanisms underlying the role of iTBS in improving various outcome indicators in older adults with chronic musculoskeletal pain?

Participants will:

Receive 1,200 stimuli during a single-session iTBS, totaling 14 days.
Undergo MRI scanning before, immediately after treatment, cognitive and pain-related tests before, immediately after treatment, and during follow-up.

Registry

clinicaltrials.gov

Start Date

September 20, 2024

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Hong Kong Polytechnic University

Responsible Party

Principal Investigator

Dr Arnold Wong Yu Lok

Associate Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

•have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 26)
•be right-handed
•be able to speak Cantonese
•chronic nonspecific low back pain, or having both chronic nonspecific low back pain and chronic knee pain that has lasted for at least 3 months
•an average pain intensity of ≥ 5 out of 10 on an 11-point numerical rating scale in the last 7 days, where 0 means "no pain" and 10 means "worst pain imaginable"
•having pain at least half of the days in the past 4 weeks.
•have at least 6 years of formal education and know how to read and write Chinese
•agree to sign an informed consent and complete the experiment tests
•be able to communicate via email or text message, as several study measures will be collected electronically

Exclusion Criteria

•inability to ambulate without assistance from another person (canes or walkers will be allowed);
•having specific causes of chronic nonspecific low back pain, or having both chronic nonspecific low back pain and chronic knee pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
•having other concurrent musculoskeletal conditions at other body parts (e.g., fibromyalgia, or neck pain)
•self-reported history of lumbar or lower extremity surgery
•self-reported history of neurological or psychiatric disorders (e.g., stroke, brain surgery, head trauma; schizophrenia, multiple personality disorder, dissociative identity disorder, stroke) or self-reported cancer history
•self-reported specific inflammatory disorder: rheumatoid arthritis, rheumatica, scleroderma, lupus, or polymyositis
•unexplained, unintended weight loss of 20 lbs or more in the past year
•cauda equina syndrome
•uncorrected visual deficit
•drug or alcohol addiction

Outcomes

Primary Outcomes

ITBS acceptability questionnaire

Time Frame: Immediately after the intervention

ITBS acceptability questionnaire has ten items of positive acceptability, ranged from 10 to 50, and it also has five items of negative acceptability, ranged from 5 to 25. The iTBS acceptability questionnaire has a total score ranging from 15 to 75.

The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate

Time Frame: Immediately after the intervention

The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate will be evaluated as our primary outcomes, because of the feasibility of the study.

Pain intensity assessment

Time Frame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.

The 11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.

Secondary Outcomes

Disability evaluation(Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.)
Cognitive function screening(Baseline)
Cognitive inhibition test inside magnetic resonance imaging scanning(Baseline, immediately after the intervention.)
Cognitive flexibility test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
Depression, anxiety, and stress test(Baseline)
Physical activity assessment(Baseline, immediately after the intervention, one-month follow-up timepoint.)
Sleep quality assessment(Baseline, immediately after the intervention, one-month follow-up timepoint.)
Cognitive flexibility test inside magnetic resonance imaging scanning(Baseline, immediately after the intervention.)
Perseveration and abstract reasoning test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
Working memory Test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
Pain catastrophizing assessment(Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.)
Pain drawing test(Baseline)
Frailty status assessment(Baseline, immediately after the intervention, one-month follow-up timepoint.)
Working memory test inside magnetic resonance imaging scanning(Baseline, immediately after the intervention)
Inhibition test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)