Clinical trial NCT06709963: The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Non-Specific Low Back Pain
Chronic Knee Pain
Chronic Musculoskeletal Pain
Keywords: Chronic non-specific low back pain
rTMS
Sham
Chronic knee pain
DLPFC
chronic musculoskeletal pain
iTBS
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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

Participants will:

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


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
* 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)

Primary outcomes:
measure: The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate
timeFrame: Immediately after the intervention
measure: ITBS acceptability questionnaire
timeFrame: Immediately after the intervention
measure: Pain intensity assessment
timeFrame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
Secondary outcomes:
measure: Depression, anxiety, and stress test
timeFrame: Baseline
measure: Disability evaluation
timeFrame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
measure: Pain catastrophizing assessment
timeFrame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
measure: Pain drawing test
timeFrame: Baseline
measure: Frailty status assessment
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
measure: Physical activity assessment
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
measure: Sleep quality assessment
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
measure: Cognitive function screening
timeFrame: Baseline
measure: Working memory test inside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention
measure: Cognitive flexibility test inside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention.
measure: Cognitive inhibition test inside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention.
measure: Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
measure: Working memory Test outside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
measure: Cognitive flexibility test outside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
measure: Inhibition test outside magnetic resonance imaging scanning
timeFrame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arnold Dr WONG
role: PRINCIPAL_INVESTIGATOR
References: