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| ID | Type | Description | Link |
|---|---|---|---|
| CX001996 | Other Grant/Funding Number | Charleston CSR&D |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- real tDCS and real CBI | Experimental | 4 active treatments of tDCS and active cognitive behavioral intervention (CBI) |
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| Group 2- real tDCS and sham CBI | Experimental | 4 active treatments of tDCS and education-only-control cognitive intervention |
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| Group 3- sham tDCS and real CBI | Experimental | 4 sham treatments of tDCS and active cognitive behavioral intervention (CBI) |
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| Group 4- sham tDCS and sham CBI | Sham Comparator | 4 sham treatments of tDCS and education-only-control cognitive intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative opioid 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 |
| 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 |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey J Borckardt, PhD | Contact | (843) 577-5011 | 5854 | Jeffrey.Borckardt@va.gov |
| Donald (Hugh) L Myrick, MD BS | Contact | (843) 789-7316 | Donald.Myrick@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J Borckardt, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Recruiting | Charleston | South Carolina | 29401-5703 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D008722 | Methods |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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. |
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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 |
| D012816 | Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D008919 | Investigative Techniques |