Total Hip Arthroplasty (Postoperative Pain), Total Knee Arthroplasty (Postoperative Pain)
Conditions
Keywords
total knee arthroplasty, pain, postsurgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA
Brief summary
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
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.
Interventions
DEVICETranscranial 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.
BEHAVIORALCognitive-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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing total knee arthroplasty (TKA) or total hip arthroplasty (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 Cognitive-Behavioral (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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative opioid pain medication use | 48 hours | Patient controlled analgesic medication usage (the morphine equivalent dose (MED); milligrams (mg) of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term outcomes of patient reported pain ratings | 1 month | long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey J Borckardt, PhD
Ralph H. Johnson VA Medical Center, Charleston, SC
Outcome results
None listed