Effects of tDCS Combined With CBI on Postsurgical Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
implanted medical devices above the waist
pregnant
history of seizures
allergic to latex rubber
Trial design
Design model
Factorial
Treatments tested in this trial
Transcranial Direct Current Stimulation
DeviceTranscranial 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
BehavioralCBI 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.
Treatment groups
132 Participants
are divided into 4 treatment groupsGroup A: Group 1- real tDCS and real CBIExperimental treatment 2 interventions
Group B: Group 2- real tDCS and sham CBIExperimental treatment 2 interventions
Group C: Group 3- sham tDCS and real CBIExperimental treatment 2 interventions
Group D: Group 4- sham tDCS and sham CBISham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
48 hoursSecondary outcomes
1
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.
Time frame
1 month2
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).
Time frame
3 months3
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).
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov