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

NCT06706479 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: HSEARS20240416001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Before and immediately after the intervention.

Secondary Outcomes (8)

• Resting-state blood oxygen concentration

  Before and immediately after the intervention.

• Arithmetic performance

  Before and immediately after the intervention.

• Postural sway

  Before and immediately after the intervention.

• Timed up-and-go test (TUG)

  Before and immediately after the intervention.

• Attention

  Before and immediately after the intervention.

Study Arms (2)

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.

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.

Device: high-definition transcranial direct current stimulation

Interventions

high-definition transcranial direct current stimulation DEVICE

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.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 999077, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The allocation of the participants will be sealed in an envelope, blinding the subjects and assessors, and a third person (intervention implementer) will perform the blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: November 26, 2024
• Study Start: December 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)