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 University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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.

Time frame: Immediately after the intervention

ITBS acceptability questionnaire

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.

Time frame: Immediately after the intervention

Pain intensity assessment

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

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

Secondary Outcomes

Depression, anxiety, and stress test

The Chinese version of the short Depression Anxiety Stress Scales, scores ranged from 0 to 13, higher scores for each domain (depression, anxiety, and stress) indicate more respective problems.

Time frame: Baseline

Disability evaluation

The Hong Kong Chinese Version of the Roland-Morris Disability Questionnaire has 24 items. Scores ranged from 0 to 24, higher scores indicate worse disability.

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

Pain catastrophizing assessment

The Chinese version of Pain Catastrophizing Score. The scores ranged from 0 to 13, higher scores indicate more pain catatrophizing thought.

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

Pain drawing test

The body map scoring system indicates the location of participants' painful site

Time frame: Baseline

Frailty status assessment

Fatigue, Resistance, Ambulation, Illness, and Loss, the presence of 3 of 5 item characteristics indicate the presence of frailty, scores ranged from 0 to 5. Lower scores mean more frailty.

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

Physical activity assessment

Physical Activity Scale for the Elderly; it has 3 domains (leisure, household, and occupation activities) to measure physical activity levels of adults aged 65 or above. higher scores indicate more active.

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

Sleep quality assessment

Pittsburgh Sleep Quality Index. It has 7 domains to measure sleep quality , sleep latency, sleep duration, habital sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Scores ranged from 0 to 21, higher scores indicate poorer sleep quality.

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

Cognitive function screening

Hong Kong Montreal Cognitive Assessment. It is a cognitive screening tool specifically adapted for Chinese older adults in Hong Kong. It is designed to detect mild cognitive impairment and dementia. A score \< 26 suggests participant has mild cognitive impairment.

Time frame: Baseline

Working memory test inside magnetic resonance imaging scanning

The digit 2-back task, more response accuracy of digits indicates better working memory

Time frame: Baseline, immediately after the intervention

Cognitive flexibility test inside magnetic resonance imaging scanning

The More Odd Shifting task, It requires participants to switch between different mental sets or rules, such as identifying odd numbers or shifting between different categories. Better response accuracy indicates better cognitive flexibility

Time frame: Baseline, immediately after the intervention.

Cognitive inhibition test inside magnetic resonance imaging scanning

Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference

Time frame: Baseline, immediately after the intervention.

Perseveration and abstract reasoning test outside magnetic resonance imaging scanning

The Modified Wisconsin Card Sorting Test, more correct matching of cards indicate better perseveration and abstract reasoning.

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

Working memory Test outside magnetic resonance imaging scanning

The Verbal Digits Forward and Backward Test, more correct recall of digits indicate better working memory and executive function

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

Cognitive flexibility test outside magnetic resonance imaging scanning

The Trail Making Tests, a neuropsychological test of visual attention and task switching, completing the trail correctly within a shorter period of time means better cognitive flexibility

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

Inhibition test outside magnetic resonance imaging scanning

Go/NoGo task, more response accuracy indicates better control of inhibition.

Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts