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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorThe Hong Kong Polytechnic University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ITBS

    Device

    We will use a coil called Cool-6000 A/P to conduct real and sham control. This coil will be placed on the scalp of older adults. The iTBS protocol will begin with a 2-s burst train (totally 30 pulses), repeating every 10 s. Each burst train will consist of 10 triplet pulses with an inter-burst interval of 0.16 s, thus the triplets fire at a rate of 5 Hz. ITBS parameters will include three continuous pulses at 50 Hz repeated at 5 Hz (2s on, 8s off) for a total of 600 pulses. We will administer two rounds of iTBS per treatment day, with a 15-minute interval between the two sessions. In total, each participant will receive 1,200 stimuli during a single-session iTBS, totaling for 14 days. Each treatment session will last for about 30 minutes. Intermittent θ-burst stimulation intensity will be set at 70% of the resting motor threshold.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ShamSham comparator 1 intervention
Group B: Left DLPFCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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
2

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.
3

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.
4

Pain drawing test

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

Time frame
Baseline

Other outcomes

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