The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high-definition transcranial direct current stimulation.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device high-definition transcranial direct current stimulation
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.
Primary outcome measures
- Current back-pain intensity [Time frame: Before and immediately after the intervention.]
Secondary outcome measures (8)
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT06706479 · HSEARS20240416001