Effects of tDCS Combined With CBI on Postsurgical Pain

Официальное название

tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

Обзор

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.

Подробное описание

The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS, brief Cognitive-Behavioral (CB) intervention and their combination on pain among veterans undergoing unilateral TKA or THA. 132 patients undergoing TKA/THA will be randomly assigned to one of four groups:

1. Group1- real tDCS + real CB intervention 2. Group2- real tDCS + education-only-control intervention 3. Group3- sham tDCS + real CB intervention 4. Group4- sham tDCS +education-only-control intervention

Participants will receive 2 tDCS/CBI treatments on the day of their surgery, and 2 tDCS/CBI treatments the day after their surgery. Participants' perioperative medication usage and pain ratings will be tracked during postoperative hospital stay. Follow-up data regarding pain and opioid use will be collected at 1, 3 and 6-months.

Вмешательства

• Устройство Transcranial Direct Current Stimulation
  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.
• Поведенческое Cognitive-Behavioral (CB) intervention
  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.

Первичные конечные точки

• postoperative opioid pain medication use [Срок оценки: 48 hours]

Вторичные конечные точки (3)

• Long term outcomes of patient reported pain ratings [Срок оценки: 1 month]
• Long term outcomes of patient reported pain ratings [Срок оценки: 3 months]
• Long term outcomes of patient reported pain ratings [Срок оценки: 6 months]

Критерии участия

Критерии включения

Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.

• Mentally capable of reading, writing, giving consent, and following instructions
• Cleared for, and scheduled for unilateral TKA or THA surgery
• Able to hear CB intervention and understand educational materials through headphones in English

Критерии исключения

• implanted medical devices above the waist
• pregnant
• history of seizures
• allergic to latex rubber
• psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston

Идентификаторы

NCT: NCT04199780 · NURB-001-19S · CX001996

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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