Effects of tDCS Combined With CBI on Postsurgical Pain

Conditions

• Total Hip Arthroplasty (Postoperative Pain)
• Total Knee Arthroplasty (Postoperative Pain)

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Transcranial Direct Current Stimulation — DEVICE
  Transcranial direct current stimulation (tDCS), stimulates specific areas of the brain via electric current passed through electrodes placed on the scalp. During tDCS, low amplitude direct currents penetrates the skull to enter the brain and modulates neuronal activity.
• Cognitive-Behavioral (CB) intervention — BEHAVIORAL
  CBI generally consist of cognitive coping strategies (e.g., distraction, relabeling, reducing pain-catastrophizing) and self-management (e.g., relaxation strategies, guided imagery) designed to enhance perceived control and reduce sympathetic nervous system tone.

Study Details

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI). This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles. This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). The Veteran may benefit in the form of decreased pain and opioid requirements following knee or hip replacement surgery. However, benefit is only likely if Veterans are randomized to one of the 3 (out of 4) groups. This study hopes to determine the effects of these interventions and combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Key Dates

Start date

Jan 11, 2021

Status verified

Jul 2025

Primary completion

Jan 1, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

132 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1- real tDCS and real CBI
  4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
• Experimental: Group 2- real tDCS and sham CBI
  4 active treatments of tDCS and education-only-control cognitive intervention
• Experimental: Group 3- sham tDCS and real CBI
  4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
• Sham Comparator: Group 4- sham tDCS and sham CBI
  4 sham treatments of tDCS and education-only-control cognitive intervention

Primary Outcome Measure

postoperative opioid pain medication use [ Time Frame: 48 hours ]

Central Contacts

• Jeffrey J Borckardt, PhD
  (843) 577-5011
  [email protected]
• Donald (Hugh) L Myrick, MD BS
  (843) 789-7316
  [email protected]

Locations (1)

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