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Search / Trial NCT06709963

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

Launched by THE HONG KONG POLYTECHNIC UNIVERSITY · Nov 25, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Chronic Non Specific Low Back Pain R Tms Sham Chronic Knee Pain Dlpfc Chronic Musculoskeletal Pain I Tbs

ClinConnect Summary

This clinical trial is looking at a treatment called accelerated intermittent Theta Burst Stimulation (iTBS) to see how it can help older adults with chronic musculoskeletal pain, such as long-lasting low back pain or knee pain. The researchers want to find out if stimulating a specific part of the brain can reduce pain and improve thinking abilities in participants. They will also use MRI scans to understand how this treatment works in the brain.

To join the study, participants need to be right-handed, speak Cantonese, and have had pain for at least three months, with a pain level of 5 or higher on a scale of 0 to 10. They should also have normal cognitive function and at least six years of formal education. If eligible, participants will receive the treatment over 14 days and will undergo tests to measure pain and cognitive function, both before and after the treatment. It's important to know that certain medical conditions or surgeries may prevent someone from joining, so a thorough screening will be conducted.

Gender

ALL

Eligibility criteria

  • 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)

About The Hong Kong Polytechnic University

The Hong Kong Polytechnic University (PolyU) is a leading institution in applied research and education, dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, PolyU focuses on conducting rigorous and ethically sound research to enhance understanding of medical interventions and improve patient outcomes. The university leverages its multidisciplinary expertise, state-of-the-art facilities, and collaboration with industry partners to facilitate groundbreaking studies that address pressing health challenges. Committed to fostering an environment of academic excellence, PolyU aims to translate research findings into practical solutions that benefit society and contribute to the global advancement of healthcare.

Locations

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Trial Officials

Arnold Dr WONG

Principal Investigator

The Hong Kong Polytechnic University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported