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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator |
| |
| Left DLPFC | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Disability evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Dr. Huang | Contact | +852 5303 7752 | fan2023.huang@connect.polyu.hk | |
| Yat Ching Miss Wong | Contact | +852 60799195 | yatching.wong@connect.polyu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Arnold Dr WONG | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Hong Kong | Hong Kong |
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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. |
| 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. | 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 | 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. | 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. | 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. | 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. | Baseline |
| Working memory test inside magnetic resonance imaging scanning | The digit 2-back task, more response accuracy of digits indicates better working memory | 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 | 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 | 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. | 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 | 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 | 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. | Baseline, immediately after the intervention, one-month follow-up timepoint. |