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

Официальное название

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.

Обзор

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.

Вмешательства

• Устройство ITBS
  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 t

Первичные конечные точки

• The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate [Срок оценки: Immediately after the intervention]
• ITBS acceptability questionnaire [Срок оценки: Immediately after the intervention]
• Pain intensity assessment [Срок оценки: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06709963 · HSEARS20240411013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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