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

NCT06709963 | Recruiting FDA Device

• 1 other identifier: HSEARS20240411013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is left dorsolateral prefrontal cortex stimulation using accelerated iTBS effective for older adults with chronic musculoskeletal pain?
2. 2.What are the neurophysiological mechanisms underlying the role of iTBS in improving various outcome indicators in older adults with chronic musculoskeletal pain?
3. 3.Receive 1,200 stimuli during a single-session iTBS, totaling 14 days.
4. 4.Undergo MRI scanning before, immediately after treatment, cognitive and pain-related tests before, immediately after treatment, and during follow-up.

Conditions

Chronic Non-Specific Low Back Pain; Chronic Knee Pain; Chronic Musculoskeletal Pain

Keywords

Chronic non-specific low back pain; rTMS; Sham; Chronic knee pain; DLPFC; chronic musculoskeletal pain; iTBS

Outcome Measures

Primary Outcomes (3)

• The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate

  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.

  Immediately after the intervention

• ITBS acceptability questionnaire

  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.

  Immediately after the intervention

• Pain intensity assessment

  The 11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.

  Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.

Secondary Outcomes (15)

• Depression, anxiety, and stress test

  Baseline

• Disability evaluation

  Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.

• 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.

Study Arms (2)

Sham

SHAM COMPARATOR

Device: ITBS

Left DLPFC

EXPERIMENTAL

Device: ITBS

Interventions

ITBS DEVICE

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 two rounds of iTBS per treatment day, with a 15-minute interval between the two sessions. In total, each participant will receive 1,200 stimuli during a single-session iTBS, totaling for 14 days. Each treatment session will last for about 30 minutes. Intermittent θ-burst stimulation intensity will be set at 70% of the resting motor threshold.

Left DLPFC; Sham

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Arnold Dr WONG

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Dr. Huang

CONTACT

+852 5303 7752; fan2023.huang@connect.polyu.hk

Yat Ching Miss Wong

CONTACT

+852 60799195; yatching.wong@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)