Chronic Low Back PainNCT06706479
The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain
A study testing high-definition transcranial direct current stimulation in people with Chronic Low Back Pain, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the effects and mechanisms of high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on chronic low back pain and balance in older adults. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- high-definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 31 Dec 2025
- 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
- Aged 60-85 years;
- With non-specific chronic low back pain that has no definitive diagnosis but lasted for at least 3 months, typically occurs in the area between the lower rib margins and the buttock creases;
- With an average pain intensity over the last week to be ≥ 3 on an 11-point numerical rating scale (NRS) anchored with "no pain" at zero and "worst pain imaginable" at 10;
- Have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 22);
- Who agree to sign an informed consent form.
Who cannot join
- Inability to ambulate without assistance from another person or tools (e.g., canes or walkers);
- Having specific causes of low back pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
- Having other acute or overt musculoskeletal conditions in other parts of the body (e.g., fractures, severe pain, multiple joint pain (e.g., knee pain));
- History of lumbar or lower extremity surgery;
- Receiving LBP treatment within the past one month or at present;
- Have never received non-invasive brain stimulation (e.g., transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcranial alternating current stimulation) before.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain: a Randomized Controlled Trial
The goal of this clinical trial is to investigate the effects and mechanisms of high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on chronic low back pain and balance in older adults. The main questions it aims to answer are:
Primary hypothesis 1: Active stimulation would have greater improvement in pain and balance, reduced left dorsolateral prefrontal cortex activation than sham stimulation.
Read more
Primary hypothesis 2: Active stimulation would have enhanced functional connectivity than sham stimulation.
Primary hypothesis 3: The balance improvement would be related to reduced pain, decreased left dorsolateral prefrontal cortex activation, enhanced functional connectivity, attention, and/or executive function.
Participants will be randomly received a single-session of high-definition transcranial direct current stimulation (active or sham stimulation). Before and immediately after the intervention, balance (semi-tandem stance and timed up-and-go test (TUG)) and cognitive (attention and executive function) tests will be assessed.
- Conditions
- Chronic Low Back Pain
- Being tested
- high-definition transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-definition transcranial direct current stimulationDevice
High-definition transcranial direct current stimulation is a novel non-invasive brain stimulation technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation. The anode increases cortical excitability, while cathode decreases cortical excitability.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | For the active stimulation, the current will be ramped up from 0 to 2 mA over the initial 30-s period and then maintain the current of 2 mA for 20 minutes, following by a 30-s ramp-down period. Receives: Device: high-definition transcranial direct current stimulation |
| Sham stimulation | Experimental | The participants will receive the same intervention procedures, but the intervention will have no therapeutic effect. Specifically, for the sham stimulation, participants will only experience 30-s ramp-up and 30-s ramp-down periods at both the commencement and end of the stimulation. Receives: Device: high-definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current back-pain intensity
The current back-pain intensity will be assessed with the 11-point numerical rating scale anchored with "no pain" at zero and "worst pain imaginable" at 10.
Measured: Before and immediately after the intervention.
Secondary outcomes (8)
Resting-state blood oxygen concentration
Resting-state blood oxygen concentration (indicated by Oxyhemoglobin concentration (μmol)) will be measured using the portable fNIRS imaging system (NIRSport 2, NIRx Medical Technologies LLC, Glen Head, NY, USA). We will instruct participants to sit still and comfortably with their eyes open, lean against the back rest, and look at a fixation cross one meter in front of them for 5 minutes.
Measured: Before and immediately after the intervention.
Arithmetic performance
Participants will be required to perform the cognitive task in the seated postition (3 x 30s). The cognitive task is serial subtraction from a random three-digit number (200-999) by 7s audibly. The number of correct and incorrect answers will be recorded.
Measured: Before and immediately after the intervention.
Postural sway
Postural sway will be assessed by APDM® Mobility Lab (APDM, Inc., Portland, OR, USA) in the following tests in a random order: (1) semi-tandem stance on firm surfaces without cognitive task (3 x 30s), (2) semi-tandem stance on firm surfaces with cognitive task (3 x 30s), (3) semi-tandem stance on foam surfaces without cognitive task (3 x 30s), (4) semi-tandem stance on foam surfaces with cognitive task (3 x 30s). The cognitive task is serial subtraction from a random three-digit number (200-999) by 7s audibly. No instructions are given regarding task prioritization. During the standing tests, cortical activation will be measured using the NIRSport 2 system with its control box placed in a backpack worn by participants.
Measured: Before and immediately after the intervention.
Timed up-and-go test (TUG)
TUG will be performed in random order in the following tests: (1) TUG without a cognitive task (3 trials) and (2) TUG with a cognitive task (3 trials). The cognitive task involves serial subtraction from a random three-digit number (ranging from 200 to 999) by subtracting 7s audibly. No specific instructions are provided regarding task prioritization. The time (in seconds) taken to complete the TUG, along with the number of correct and incorrect answers, will be recorded for statistical analysis.
Measured: Before and immediately after the intervention.
Attention
Attention will be assessed using the Trail Making Test - A (TMT-A). TMT-A involves connecting a series of 25 square and circle encircled numbers in ascending order, without lifting the pen from the paper. Errors will be corrected immediately and re-establish the sequence. The time (in seconds) to complete the TMT-A will be recorded for statistical analysis.
Measured: Before and immediately after the intervention.
Executive function
Executive function will be assessed using TMT-A and the Trail Making Test - B (TMT-B). TMT-A involves connecting a series of 25 square and circle encircled numbers in ascending order, without lifting the pen from the paper. In TMT-B, the numbers from 1 to 25 are twice presented in square and circle shapes ("1" is only presented once). Participants are instructed to connect the numbers in ascending order, alternating between the squares and circles. Errors will be corrected immediately and re-establish the sequence. The time to complete the TMT-A and TMT-B will be recorded. Executive function will be indicated by the difference in TMT-A and TMT-B (TMT-B minus TMT-A in seconds).
Measured: Before and immediately after the intervention.
Side or adverse effects
Any side or adverse effects (e.g., itching, tingling and burning sensations under electrodes) related to the interventions will be monitored in all participants.
Measured: During and 1 hour after the intervention.
Blinding efficacy
A blinding efficacy questionnaire will be completed after intervention. If the participant believes that they receive active or sham stimulation, they will be asked to state their confidence in this belief on a scale of 1 (not confident) to 3 (very confident).
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start10 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706479
- Sponsor's protocol ID
- HSEARS20240416001
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06706479
- Acronym / sponsor ID
- HSEARS20240416001
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 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 investigate the effects and mechanisms of high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on chronic low back pain and balance in older adults. The main questions it aims to answer are:
Primary hypothesis 1: Active stimulation would have greater improvement in pain and balance, reduced left dorsolateral prefrontal cortex activation than sham stimulation.
Primary hypothesis 2: Active stimulation would have enhanced functional connectivity than sham stimulation.
Primary hypothesis 3: The balance improvement would be related to reduced pain, decreased left dorsolateral prefrontal cortex activation, enhanced functional connectivity, attention, and/or executive function.
Participants will be randomly received a single-session of high-definition transcranial direct current stimulation (active or sham stimulation). Before and immediately after the intervention, balance (semi-tandem stance and timed up-and-go test (TUG)) and cognitive (attention and executive function) tests will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: high-definition transcranial direct current stimulationFor the active stimulation, the current will be ramped up from 0 to 2 mA over the initial 30-s period and then maintain the current of 2 mA for 20 minutes, following by a 30-s ramp-down period. |
| Sham stimulation | Experimental | Device: high-definition transcranial direct current stimulationThe participants will receive the same intervention procedures, but the intervention will have no therapeutic effect. Specifically, for the sham stimulation, participants will only experience 30-s ramp-up and 30-s ramp-down periods at both the commencement and end of the stimulation. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60-85 years;
- With non-specific chronic low back pain that has no definitive diagnosis but lasted for at least 3 months, typically occurs in the area between the lower rib margins and the buttock creases;
- With an average pain intensity over the last week to be ≥ 3 on an 11-point numerical rating scale (NRS) anchored with "no pain" at zero and "worst pain imaginable" at 10;
- Have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 22);
- Who agree to sign an informed consent form.
Key exclusion criteria (6 listed)
- Inability to ambulate without assistance from another person or tools (e.g., canes or walkers);
- Having specific causes of low back pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
- Having other acute or overt musculoskeletal conditions in other parts of the body (e.g., fractures, severe pain, multiple joint pain (e.g., knee pain));
- History of lumbar or lower extremity surgery;
- Receiving LBP treatment within the past one month or at present;
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 |
|---|---|---|
| high-definition transcranial direct current stimulationHigh-definition transcranial direct current stimulation is a novel non-invasive brain stimulation technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation. The anode increases cortical excitability, while cathode decreases cortical excitability. | Device | Active stimulation, Sham stimulation |
Primary outcome
Current back-pain intensity
Time frame: Before and immediately after the intervention.
The current back-pain intensity will be assessed with the 11-point numerical rating scale anchored with "no pain" at zero and "worst pain imaginable" at 10.
8 secondary outcomes
Resting-state blood oxygen concentration
Time frame: Before and immediately after the intervention.
Arithmetic performance
Time frame: Before and immediately after the intervention.
Postural sway
Time frame: Before and immediately after the intervention.
Timed up-and-go test (TUG)
Time frame: Before and immediately after the intervention.
Attention
Time frame: Before and immediately after the intervention.
Executive function
Time frame: Before and immediately after the intervention.
Side or adverse effects
Time frame: During and 1 hour after the intervention.
Blinding efficacy
Time frame: Immediately after the intervention.
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 18 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-definition transcranial direct current stimulation in people with Chronic Low Back Pain, run by The Hong Kong Polytechnic University at 1 site in China.
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 6 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: enrolling by invitation, as of the sponsor's last update on 18 Apr 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 China. 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. 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?
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?
Current back-pain intensity (time frame: Before and immediately after the intervention.). 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 18 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.