Total Hip Arthroplasty(Postoperative Pain), Total Knee Arthroplasty (Postoperative Pain)
Conditions
Keywords
total knee arthroplasty, pain, post-surgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA
Brief summary
The proper control of acute and chronic pain is one of the most important areas in health care. Despite the profound advances in neuroscience over the past 20 years, the investigators still largely use opiate narcotics, much as was done in the Civil War. Total knee arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee pain is often a complaint that precedes TKA, the procedure itself is associated with considerable post-operative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery time and hospital length of stay. New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions. In two independent preliminary pilot studies, the Investigators have shown that tDCS can reduce post-operative PCA use by as much as 46% while simultaneously reducing subjective pain ratings. The present study aims to determine the effects of transcranial direct current stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and post-surgical complications during the 48-hour post-operative period following total knee arthroplasty.
Detailed description
The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS. Real tDCS was administered at 2mA whereas sham tDCS delivered none. 120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have 4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 - 1 session of real tDCS (+ 3 sham-sessions). Group 4 is Sham tDCS, which does not involve any real stimulation. The participants will receive 2 tDCS treatments on the day of their surgery, and 2 tDCS treatments the day after their surgery.
Interventions
DEVICE4 Real sessions of Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.
DEVICE2 Real Sessions of Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.
DEVICE1 Real Session of Transcranial Direct Current Stimulation
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.
DEVICESham Transcranial Direct Current Stimulation
Four sessions of sham tDCS; control intervention.
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
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Participants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC. * Between the ages of 19 and 90 * Mentally capable of reading, writing, giving consent, and following instructions * Cleared for and scheduled for unilateral TKA or THA surgery
Exclusion criteria
* Implanted medical devices above the waist * Pregnant * History of seizures * Allergic to latex rubber * Psychiatric conditions other than for depression and/or anxiety disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Pain Medication Dose | 2-Days | Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period. |
| Patient-reported Pain Intensity Ratings | 2-Days | Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of 0- no pain at all to maximum of 10- worst pain imaginable. Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Average Pain Ratings | 6 Months | Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: 0- no pain, 10-worst pain imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| tDCS Full Dose 4 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp. | 30 |
| tDCS Half Dose 2 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp. | 30 |
| tDCS Minimal Dose 1 active treatment
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp. | 30 |
| Sham tDCS no active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp. | 29 |
| Total | 119 |
Baseline characteristics
| Characteristic | tDCS Full Dose | Total | Sham tDCS | tDCS Minimal Dose | tDCS Half Dose |
|---|---|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 8.73 | 64.7 years STANDARD_DEVIATION 8.5 | 64.2 years STANDARD_DEVIATION 8.14 | 63.5 years STANDARD_DEVIATION 7.93 | 67.0 years STANDARD_DEVIATION 8.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 116 Participants | 28 Participants | 29 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Procedure Type Total Hip Arthroplasty (THA) | 12 Participants | 37 Participants | 9 Participants | 7 Participants | 9 Participants |
| Procedure Type Total Knee Arthroplasty (TKA) | 18 Participants | 82 Participants | 20 Participants | 23 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 34 Participants | 9 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 82 Participants | 19 Participants | 19 Participants | 22 Participants |
| Region of Enrollment United States | 30 Participants | 119 Participants | 29 Participants | 30 Participants | 30 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 1 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 28 Participants | 112 Participants | 28 Participants | 27 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 29 |
Outcome results
Primary
Patient-reported Pain Intensity Ratings
Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of 0- no pain at all to maximum of 10- worst pain imaginable. Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.
Time frame: 2-Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS Full Dose | Patient-reported Pain Intensity Ratings | 5.33 score on a scale | Standard Error 0.44 |
| tDCS Half Dose | Patient-reported Pain Intensity Ratings | 5.59 score on a scale | Standard Error 0.43 |
| tDCS Minimal Dose | Patient-reported Pain Intensity Ratings | 5.84 score on a scale | Standard Error 0.48 |
| Sham tDCS | Patient-reported Pain Intensity Ratings | 5.33 score on a scale | Standard Error 0.56 |
Primary
Post-operative Opioid Pain Medication Dose
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Time frame: 2-Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS Full Dose | Post-operative Opioid Pain Medication Dose | 26.99 mg of morphine equivalent dose (MED) | Standard Error 2.99 |
| tDCS Half Dose | Post-operative Opioid Pain Medication Dose | 31.12 mg of morphine equivalent dose (MED) | Standard Error 3.73 |
| tDCS Minimal Dose | Post-operative Opioid Pain Medication Dose | 28.65 mg of morphine equivalent dose (MED) | Standard Error 31.12 |
| Sham tDCS | Post-operative Opioid Pain Medication Dose | 33.15 mg of morphine equivalent dose (MED) | Standard Error 5.6 |
Secondary
Patient-reported Average Pain Ratings
Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: 0- no pain, 10-worst pain imaginable.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS Full Dose | Patient-reported Average Pain Ratings | 3.06 score on a scale | Standard Error 0.46 |
| tDCS Half Dose | Patient-reported Average Pain Ratings | 3.45 score on a scale | Standard Error 0.72 |
| tDCS Minimal Dose | Patient-reported Average Pain Ratings | 3.77 score on a scale | Standard Error 0.74 |
| Sham tDCS | Patient-reported Average Pain Ratings | 4.89 score on a scale | Standard Error 0.59 |