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

Last updated: January 14, 2025
Sponsor: The Hong Kong Polytechnic University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Muscle Pain

Treatment

ITBS

Clinical Study ID

NCT06709963
HSEARS20240411013
  • Ages 60-85
  • All Genders

Study Summary

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

Inclusion

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 painand 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 inthe 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 becollected electronically

Exclusion

Exclusion Criteria:

  • inability to ambulate without assistance from another person (canes or walkers willbe allowed);

  • having specific causes of chronic nonspecific low back pain, or having both chronicnonspecific low back pain and chronic knee pain (e.g., spinal stenosis, lumbar discherniation, 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, brainsurgery, head trauma; schizophrenia, multiple personality disorder, dissociativeidentity 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) examinationbased on the MRI safety screening form of University Research Facility in Behavioraland Systems Neuroscience (UBSN) at The Hong Kong Polytechnic University (PolyU)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: ITBS
Phase:
Study Start date:
September 20, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • The Hong Kong Polytechnic University

    Hong Kong,
    Hong Kong

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.