The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain

The Hong Kong Polytechnic University

Status: Invitation-only

Conditions: Chronic Low Back Pain

Treatments: Device: high-definition transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06706479

HSEARS20240416001

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Active stimulation

Experimental group

Description:

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.

Treatment:

Device: high-definition transcranial direct current stimulation

Sham stimulation

Experimental group

Description:

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.

Treatment:

Device: high-definition transcranial direct current stimulation