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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 Pilot Trial with Six-month Follow-up
Led by The Hong Kong Polytechnic University · Updated on 2025-01-15
30
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of accelerated intermittent Theta Burst Stimulation (iTBS) on pain relief and cognitive function in older adults aged 60 to 85 years who have chronic musculoskeletal pain, including chronic nonspecific low back pain and chronic knee pain lasting at least 3 months. The study also uses magnetic resonance imaging (MRI) to understand how iTBS influences brain activity related to pain and cognitive improvements. It aims to determine whether stimulating the left dorsolateral prefrontal cortex with accelerated iTBS is effective for this population and to explore the underlying neurophysiological mechanisms. Participants will receive iTBS using a Cool-6000 A/P coil placed on their scalp. The protocol includes two rounds of stimulation per treatment day, each delivering 600 pulses with a 15-minute break between sessions, for a total of 1,200 stimuli daily over 14 days. Each session lasts about 30 minutes, with stimulation intensity set at 70% of the resting motor threshold. Both real and sham (placebo) iTBS treatments will be administered in this double-blinded, randomized, sham-controlled trial. Throughout the study, participants will undergo MRI scans before and immediately after treatment, along with tests assessing cognitive function and pain intensity at multiple points: baseline, immediately after treatment, and during follow-ups at one, three, and six months. Researchers will track recruitment and retention rates, reasons for drop-out, and participants' acceptability of the iTBS intervention. Pain levels and cognitive changes will be carefully monitored to evaluate the treatment's impact over time.
CONDITIONS
Official Title
The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal cognitive function (Hong Kong Montreal Cognitive Assessment score 6)
- Right-handed
- Able to speak Cantonese
- Chronic nonspecific low back pain or both chronic nonspecific low back pain and chronic knee pain lasting at least 3 months
- Average pain intensity 5 out of 10 in the last 7 days
- Pain experienced on at least half of the days in the past 4 weeks
- At least 6 years of formal education and able to read and write Chinese
- Agree to sign informed consent and complete study tests
- Able to communicate via email or text message for electronic study measures
You will not qualify if you...
- Unable to walk without assistance (canes or walkers allowed)
- Specific causes of chronic nonspecific low back pain or chronic knee pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection)
- Other musculoskeletal conditions at other body parts (e.g., fibromyalgia, neck pain)
- History of lumbar or lower extremity surgery
- History of neurological or psychiatric disorders (e.g., stroke, brain surgery, head trauma, schizophrenia, multiple personality disorder, dissociative identity disorder)
- History of cancer
- Specific inflammatory disorders (rheumatoid arthritis, rheumatica, scleroderma, lupus, polymyositis)
- Unexplained 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 within 24 hours before the study
- Claustrophobia
- Contraindications for MRI based on safety screening at The Hong Kong Polytechnic University
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Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Actively Recruiting
Research Team
F
Fan Dr. Huang
Y
Yat Ching Miss Wong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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