Clinical trial NCT06706479: The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


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.

Primary outcomes:
measure: Current back-pain intensity
timeFrame: Before and immediately after the intervention.
Secondary outcomes:
measure: Resting-state blood oxygen concentration
timeFrame: Before and immediately after the intervention.
measure: Arithmetic performance
timeFrame: Before and immediately after the intervention.
measure: Postural sway
timeFrame: Before and immediately after the intervention.
measure: Timed up-and-go test (TUG)
timeFrame: Before and immediately after the intervention.
measure: Attention
timeFrame: Before and immediately after the intervention.
measure: Executive function
timeFrame: Before and immediately after the intervention.
measure: Side or adverse effects
timeFrame: During and 1 hour after the intervention.
measure: Blinding efficacy
timeFrame: Immediately after the intervention.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
state: Hong Kong
Study officials:
References: