Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty (TDCSTKA)

Assiut University

Status: Completed

Conditions: Knee Replacement

Treatments: Device: Sham tDCS; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02704182

tDCS in TKA

Details and patient eligibility

About

The objective of this study is to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line) after 1st, 2nd, 3rd and 4th sessions.

Full description

The study aims to to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients.

Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS.

Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (baseline) after 1st, 2nd, 3rd and 4th sessions.

Enrollment: 46 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Providing informed consent to participate in the study.
2. age >30 years and <60 years both genders.
3. ASA I to II patients.
4. postoperative unilateral total knee arthroplasty.

Exclusion criteria

1. Contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants).
2. Neurological or psychiatric pathology.
3. Patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid.
4. History of substance abuse.
5. Severe cardio-pulmonary, renal, hepatic diseases.
6. Pregnancy and lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Real tDCS

Active Comparator group

Description:

Direct current stimulation using anodal electrode, 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Treatment:

Device: tDCS

Sham tDCS

Sham Comparator group

Description:

Sham direct current stimulation, 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Treatment:

Device: Sham tDCS