NCT06709963招募中不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ITBS acceptability questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
ITBS acceptability questionnaire
时间窗: Immediately after the intervention
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.
The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate
时间窗: Immediately after the intervention
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.
Pain intensity assessment
时间窗: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
The 11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
次要结局
- Disability evaluation(Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.)
- Cognitive function screening(Baseline)
- Cognitive inhibition test inside magnetic resonance imaging scanning(Baseline, immediately after the intervention.)
- Cognitive flexibility test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
- Depression, anxiety, and stress test(Baseline)
- Physical activity assessment(Baseline, immediately after the intervention, one-month follow-up timepoint.)
- Sleep quality assessment(Baseline, immediately after the intervention, one-month follow-up timepoint.)
- Cognitive flexibility test inside magnetic resonance imaging scanning(Baseline, immediately after the intervention.)
- Perseveration and abstract reasoning test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
- Working memory Test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
- Pain catastrophizing assessment(Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.)
- Pain drawing test(Baseline)
- Frailty status assessment(Baseline, immediately after the intervention, one-month follow-up timepoint.)
- Working memory test inside magnetic resonance imaging scanning(Baseline, immediately after the intervention)
- Inhibition test outside magnetic resonance imaging scanning(Baseline, immediately after the intervention, one-month follow-up timepoint.)
研究者
Dr Arnold Wong Yu Lok
Associate Professor
The Hong Kong Polytechnic University
研究点 (1)
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