Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transcranial Versus Suboccipital Direct Current Stimulation

NCT04117256

Pain Transcranial Direct Current Stimulation

COMPLETED NA

Comparing Transcranial Direct Current Stimulation Montages in Stroke

NCT04340973

Acute Stroke

UNKNOWN NA

Effects of Different Intensities of Bilateral-transcranial Direct Current Stimulation in Healthy Individuals

NCT05929014

Healthy

COMPLETED NA

Searching for the Optimal tDCS Target Combined With Peripheral Electrical Stimulation in Chronic Low Back Pain

NCT04496661

Chronic Pain Low Back Pain

UNKNOWN NA

Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Interictal Dysfunction in Epilepsy

NCT02950506

Epilepsy

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real tDCS

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.

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Sham tDCS

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

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tDCS

25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Intervention Type DEVICE

Sham tDCS

25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No