Effects of tDCS Combined With CBI on Postsurgical Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Group1- real tDCS + real CB intervention Group2- real tDCS + education-only-control intervention Group3- sham tDCS + real CB intervention 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.

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

Conditions
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Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty (Postoperative Pain)

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation
* Behavioral: Cognitive-Behavioral (CB) intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1- real tDCS and real CBI<br>4 active treatments of tDCS and active cognitive behavioral intervention (CBI) | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: tDCS;Behavioral: Cognitive-Behavioral (CB) intervention<br>* 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.<br>* Other names: CBI;|
| Experimental: Group 2- real tDCS and sham CBI<br>4 active treatments of tDCS and education-only-control cognitive intervention | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: tDCS;Behavioral: Cognitive-Behavioral (CB) intervention<br>* 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.<br>* Other names: CBI;|
| Experimental: Group 3- sham tDCS and real CBI<br>4 sham treatments of tDCS and active cognitive behavioral intervention (CBI) | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: tDCS;Behavioral: Cognitive-Behavioral (CB) intervention<br>* 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.<br>* Other names: CBI;|
| Sham Comparator: Group 4- sham tDCS and sham CBI<br>4 sham treatments of tDCS and education-only-control cognitive intervention | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: tDCS;Behavioral: Cognitive-Behavioral (CB) intervention<br>* 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.<br>* Other names: CBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative opiod pain medication use | Patient controlled analgesic medication usage (the morphine equivalent dose (MED); mg of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA). | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term outcomes of patient reported pain ratings | long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale. | 1 month | 
| Long term outcomes of patient reported pain ratings | long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable). | 3 months | 
| Long term outcomes of patient reported pain ratings | long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, pain, postsurgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA