Chronic PainNCT06158321

rTMS in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia

A study testing M1 rTMS and DLPFC rTMS in people with Chronic Pain and Insomnia, run by The Hong Kong Polytechnic University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This pilot randomized controlled trial (RCT) aims to investigate the feasibility and efficiency of delivering different rTMS protocols in individuals with CLBP and insomnia. Participants will be randomly assigned to either the primary motor cortex (M1) rTMS, the dorsolateral prefrontal cortex (DLPFC) rTMS, or sham… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Pain, Insomnia
What is being tested?: M1 rTMS and DLPFC rTMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: No sites listed yet
Study dates: 1 Dec 2024to 31 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

participants aged between18 and 65 years;
willing to participate in the study and randomization;
having stable pharmacological or nonpharmacological treatments for pain or sleep at least one month prior to study participation;
having CLBP (defined as pain between 12 ribs and gluteal crease with or without leg pain that has persisted for at least three months)
diagnosing insomnia using the Brief Insomnia Questionnaire (BIQ) based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)

Who cannot join

specific causes of CLBP (e.g., spondylosis, spondyloarthropathy, or vertebral fracture);
pregnancy or nursing;
previous spinal surgery;
inflammatory or autoimmune diseases;
other sleep disorders (e.g., sleep apnea or restless leg);
presence of severe psychopathologies, neurological, or physical disease directly related to the onset of insomnia (e.g., depression, substance abuse, or alcohol abuse);

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severe dependence on hypnotic drugs;
concurrent receipt of new treatments outside the scope of the study;
contraindications to use rTMS (e.g., severe head trauma, intracranial hypertension, implanted ferromagnetic devices, history of epilepsy).

About this study

Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia: A Pilot Randomized Controlled Trial

Read the detailed description

Sleep disturbance exacerbates pain perception, disability, and poor prognosis in individuals with chronic low back pain (CLBP). A recent systematic review demonstrated that improvements in sleep disturbance were associated with corresponding improvements in pain intensity, recovery, and disability in individuals with CLBP. These findings indicate that achieving restorative sleep is likely to mitigate chronic pain symptoms. The application of rTMS at a specific frequency over a focal brain area has been proposed as a promising treatment for chronic pain and insomnia independently. To date, no studies have compared the effectiveness of different rTMS protocols in treating comorbid CLBP and insomnia. Given the above, the current study aims to investigate the feasibility and acceptability of delivering different rTMS protocols in individuals with CLBP and insomnia and explore the relative therapeutic efficacy of these protocols on pain and sleep parameters at immediate post-treatment and one-month follow-up.

Conditions: Chronic Pain, Insomnia
Being tested: M1 or DLPFC sham stimulation, M1 rTMS, DLPFC rTMS
Keywords: Chronic low back pain, Insomnia, rTMS, RCT
Medical subject headings: Chronic Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

M1 or DLPFC sham stimulationDevice
Participants receiving M1 or DLPFC sham stimulations will complete the same procedures as those in the active groups. The sham coil, with the same stimulation parameters, will provide auditory and sensory effects similar to the active coil without delivering active stimulation.
M1 rTMSDevice
Also called Participants will receive high-frequency rTMS over M1.
The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.
DLPFC rTMSDevice
The stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.

Study groups in NCT06158321
Study group	Role	What they receive
M1 or DLPFC sham stimulation	Sham comparator	Participants will receive M1 or DLPFC sham stimulations. Receives: Device: M1 or DLPFC sham stimulation
M1 rTMS	Experimental	Participants will receive high-frequency rTMS over M1. Receives: Device: M1 rTMS
DLPFC rTMS	Experimental	Participants will receive low-frequency rTMS over DLPFC. Receives: Device: DLPFC rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Eligibility rate
The percentage of eligible participants
Measured: Two weeks
Recruitment rate
The percentage of eligible individuals who provide informed consent for participation
Measured: Two weeks
Attrition rate
The percentage of recruited participants who did not attend the intervention or follow-up reassessment
Measured: Two weeks
Adherence to the intervention
The percentage of sessions attended by each participant
Measured: Two weeks
Adverse events
They will be monitored and documented after each treatment session
Measured: Two weeks
Accepatbility
To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted.
Measured: Two weeks

Secondary outcomes (9)

Pain intensity
11-point Numerical Pain Rating Scale, with 0 = no pain and 10 = worst pain. imaginable
Measured: Two and six weeks
Back-related disability
The Roland Morris Disability Questionnaire consists of 24 items, with a total score of 24 and a higher score indicating greater functional limitation.
Measured: Two and six weeks
Insomnia severity
The Insomnia Severity Index consists of seven items, with a total score of 28 and a higher score indicating severer insomnia.
Measured: Two and six weeks
Sleep quality
The Pittsburgh Sleep Quality Index consists of 19 individual items, with a total score of 21 and a higher score indicating poorer sleep quality.
Measured: Two and six weeks
Subjetcive sleep parameters
Participants will subjectively report the time of falling asleep and waking up, sleep onset latency, and quantity and duration of nighttime awakenings. Several variables will be derived from the sleep diaries, including sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset.
Measured: Two weeks
Objetcive sleep parameters
Actigraphy will be employed to collect objective sleep parameters. The software automatically generates relevant sleep parameters involving sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset.
Measured: Two weeks
Quantitative Sensory Testing (QST)
QST will include static pain threshold (thermal, pressure, or pinprick stimulus) and dynamic pain assessments (temporal or spatial summation of pain and conditioned pain modulation).
Measured: Two weeks
Electroencephalography (EEG)
EEG recordings will be conducted during the resting state. Power spectral density (PSD) will be computed by a Fast Fourier Transformation and quantify the amount of oscillatory activity in five frequency bands: delta (0.5-4.0Hz), theta (4.0-8.0 Hz), alpha (8.0-13.0 Hz), beta (14.0-30.0 Hz), and gamma (30.0-10.00Hz).
Measured: Two weeks
Pain catastrophizing
The Pain Catastrophizing Scale (PCS) consists of 13 items with a five-point Likert scale scoring from zero (not at all) to four (always). High total scores indicate more catastrophic thoughts.
Measured: Two and six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202431 Aug 2025

First posted6 Dec 2023
Study start1 Dec 2024 (estimated)
Primary completion30 Jun 2025 (estimated)
Study completion31 Aug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic 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: Parallel groups
Model description: Three-arm pilot randomized controlled trial (RCT)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06158321
Sponsor's protocol ID: HongKongPU_Jeremy
Status last verified: Aug 2023
First submitted: 24 Aug 2023
Last updated: 6 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia: A Pilot Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06158321
Acronym / sponsor ID: HongKongPU_Jeremy
Conditions: Chronic Pain, Insomnia
Keywords: Chronic low back pain, Insomnia, rTMS, RCT
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 45 participants (estimated)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 1 Dec 2024 (estimated)
Primary completion: 30 Jun 2025 (estimated)
Study completion: 31 Aug 2025 (estimated)
First posted: 6 Dec 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Three-arm pilot randomized controlled trial (RCT)

Arm	Type	Receives
M1 or DLPFC sham stimulation	Sham comparator	Device: M1 or DLPFC sham stimulationParticipants will receive M1 or DLPFC sham stimulations.
M1 rTMS	Experimental	Device: M1 rTMSParticipants will receive high-frequency rTMS over M1.
DLPFC rTMS	Experimental	Device: DLPFC rTMSParticipants will receive low-frequency rTMS over DLPFC.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

participants aged between18 and 65 years;
willing to participate in the study and randomization;
having stable pharmacological or nonpharmacological treatments for pain or sleep at least one month prior to study participation;
having CLBP (defined as pain between 12 ribs and gluteal crease with or without leg pain that has persisted for at least three months)
diagnosing insomnia using the Brief Insomnia Questionnaire (BIQ) based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)

Key exclusion criteria (9 listed)

specific causes of CLBP (e.g., spondylosis, spondyloarthropathy, or vertebral fracture);
pregnancy or nursing;
previous spinal surgery;
inflammatory or autoimmune diseases;
other sleep disorders (e.g., sleep apnea or restless leg);

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
M1 or DLPFC sham stimulationParticipants receiving M1 or DLPFC sham stimulations will complete the same procedures as those in the active groups. The sham coil, with the same stimulation parameters, will provide auditory and sensory effects similar to the active coil without delivering active stimulation.	Device	M1 or DLPFC sham stimulation
M1 rTMSAlso: Participants will receive high-frequency rTMS over M1.The stimulation parameter of the active M1-rTMS is a 10 Hz stimulation frequency with a total of 1500 stimulation pulses.	Device	M1 rTMS
DLPFC rTMSThe stimulation parameter of the active DLPFC-rTMS is a 1 Hz stimulation frequency with a total of 1500 stimulation pulses.	Device	DLPFC rTMS

Primary outcome

Eligibility rate
Time frame: Two weeks
The percentage of eligible participants
Recruitment rate
Time frame: Two weeks
The percentage of eligible individuals who provide informed consent for participation
Attrition rate
Time frame: Two weeks
The percentage of recruited participants who did not attend the intervention or follow-up reassessment
Adherence to the intervention
Time frame: Two weeks
The percentage of sessions attended by each participant
Adverse events
Time frame: Two weeks
They will be monitored and documented after each treatment session
Accepatbility
Time frame: Two weeks
To assess the acceptability of our pilot trial and treatment process, a semi-structured interview will be conducted.

9 secondary outcomes

Pain intensity
Time frame: Two and six weeks
Back-related disability
Time frame: Two and six weeks
Insomnia severity
Time frame: Two and six weeks
Sleep quality
Time frame: Two and six weeks
Subjetcive sleep parameters
Time frame: Two weeks
Objetcive sleep parameters
Time frame: Two weeks
Quantitative Sensory Testing (QST)
Time frame: Two weeks
Electroencephalography (EEG)
Time frame: Two weeks
Pain catastrophizing
Time frame: Two and six weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Recruiting
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RecruitingObservational study
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing M1 rTMS and DLPFC rTMS in people with Chronic Pain and Insomnia, run by The Hong Kong Polytechnic University.

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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eligibility rate (time frame: Two weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06158321.

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 6 Dec 2023.