The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.

The Hong Kong Polytechnic University

Status

Enrolling

Conditions

Chronic Knee Pain

Chronic Non-Specific Low Back Pain

Chronic Musculoskeletal Pain

Treatments

Device: ITBS

Study type

Interventional

Funder types

Other

Identifiers

NCT06709963

HSEARS20240411013

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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
taken alcohol, opioids or benzodiazepines medicines 24 hours before the experiment
claustrophobia
contraindications for undergoing the magnetic resonance imaging (MRI) examination based on the MRI safety screening form of University Research Facility in Behavioral and Systems Neuroscience (UBSN) at The Hong Kong Polytechnic University (PolyU)