Chronic Non-Specific Low Back PainNCT06709963
The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.
A study testing ITBS in people with Chronic Non-Specific Low Back Pain and Chronic Knee Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Chronic Non-Specific Low Back Pain, Chronic Knee Pain, Chronic Musculoskeletal Pain
- What is being tested?
- ITBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: 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.
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:
Read more
- 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.
- Being tested
- ITBS
- Keywords
- Chronic non-specific low back pain, rTMS, Sham, Chronic knee pain, DLPFC, chronic musculoskeletal pain, iTBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITBSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Not described Receives: Device: ITBS |
| Left DLPFC | Experimental | Not described Receives: Device: ITBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention
Pain intensity assessment
The 11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
Measured: 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
The Chinese version of the short Depression Anxiety Stress Scales, scores ranged from 0 to 13, higher scores for each domain (depression, anxiety, and stress) indicate more respective problems.
Measured: Baseline
Disability evaluation
The Hong Kong Chinese Version of the Roland-Morris Disability Questionnaire has 24 items. Scores ranged from 0 to 24, higher scores indicate worse disability.
Measured: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
Pain catastrophizing assessment
The Chinese version of Pain Catastrophizing Score. The scores ranged from 0 to 13, higher scores indicate more pain catatrophizing thought.
Measured: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
Pain drawing test
The body map scoring system indicates the location of participants' painful site
Measured: Baseline
Frailty status assessment
Fatigue, Resistance, Ambulation, Illness, and Loss, the presence of 3 of 5 item characteristics indicate the presence of frailty, scores ranged from 0 to 5. Lower scores mean more frailty.
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Physical activity assessment
Physical Activity Scale for the Elderly; it has 3 domains (leisure, household, and occupation activities) to measure physical activity levels of adults aged 65 or above. higher scores indicate more active.
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Sleep quality assessment
Pittsburgh Sleep Quality Index. It has 7 domains to measure sleep quality , sleep latency, sleep duration, habital sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Scores ranged from 0 to 21, higher scores indicate poorer sleep quality.
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Cognitive function screening
Hong Kong Montreal Cognitive Assessment. It is a cognitive screening tool specifically adapted for Chinese older adults in Hong Kong. It is designed to detect mild cognitive impairment and dementia. A score < 26 suggests participant has mild cognitive impairment.
Measured: Baseline
Working memory test inside magnetic resonance imaging scanning
The digit 2-back task, more response accuracy of digits indicates better working memory
Measured: Baseline, immediately after the intervention
Cognitive flexibility test inside magnetic resonance imaging scanning
The More Odd Shifting task, It requires participants to switch between different mental sets or rules, such as identifying odd numbers or shifting between different categories. Better response accuracy indicates better cognitive flexibility
Measured: Baseline, immediately after the intervention.
Cognitive inhibition test inside magnetic resonance imaging scanning
Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference
Measured: Baseline, immediately after the intervention.
Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
The Modified Wisconsin Card Sorting Test, more correct matching of cards indicate better perseveration and abstract reasoning.
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Working memory Test outside magnetic resonance imaging scanning
The Verbal Digits Forward and Backward Test, more correct recall of digits indicate better working memory and executive function
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Cognitive flexibility test outside magnetic resonance imaging scanning
The Trail Making Tests, a neuropsychological test of visual attention and task switching, completing the trail correctly within a shorter period of time means better cognitive flexibility
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Inhibition test outside magnetic resonance imaging scanning
Go/NoGo task, more response accuracy indicates better control of inhibition.
Measured: Baseline, immediately after the intervention, one-month follow-up timepoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start20 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University
- Investigators
- Arnold Dr WONG, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709963
- Sponsor's protocol ID
- HSEARS20240411013
- Status last verified
- Jan 2025
- First submitted
- 22 Nov 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06709963
- Acronym / sponsor ID
- HSEARS20240411013
- Keywords
- Chronic non-specific low back pain, rTMS, Sham, Chronic knee pain, DLPFC, chronic musculoskeletal pain, iTBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: ITBS |
| Left DLPFC | Experimental | Device: ITBS |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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"
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITBSWe 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. | Device | Left DLPFC, Sham |
Primary outcome
The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate
Time frame: 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.
ITBS acceptability questionnaire
Time frame: 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.
Pain intensity assessment
Time frame: 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.
15 secondary outcomes
Depression, anxiety, and stress test
Time frame: Baseline
Disability evaluation
Time frame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
Pain catastrophizing assessment
Time frame: Baseline, immediately after the intervention, five-month follow-up at one-month,three-month,six-month follow-up timepoints.
Pain drawing test
Time frame: Baseline
Frailty status assessment
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Physical activity assessment
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Sleep quality assessment
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Cognitive function screening
Time frame: Baseline
Working memory test inside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention
Cognitive flexibility test inside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention.
Cognitive inhibition test inside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention.
Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Working memory Test outside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Cognitive flexibility test outside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Inhibition test outside magnetic resonance imaging scanning
Time frame: Baseline, immediately after the intervention, one-month follow-up timepoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnold Dr WONG principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITBS in people with Chronic Non-Specific Low Back Pain and Chronic Knee Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fan Dr. Huang (+852 5303 7752, fan2023.huang@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recruitment rate, retention rate (completion rate), non-completion reasons, drop-out rate (time frame: Immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.