NCT02704182

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

January 31, 2016

Last Update Submit

September 12, 2020

Conditions

Knee Replacement

Keywords

Arthroplasties, Knee Replacement

Outcome Measures

Primary Outcomes (4)

  • Opioids consumption per 24 hours at the 4th day postoperative

    Measuring the consumption dose of opioids per 24 hours at the fourth day

    day 4 postoperative

  • Opioids consumption / 24 hours at the third day postoperative

    Measuring the consumption dose of opioids per 24 hours at the third day postoperative

    day 3 postoperative

  • Opioids Consumption / 24 hours at the second day postoperative

    Measuring the consumption dose of opioids per 24 hours at the second day post-operative

    day 2 postoperative

  • Opioids consumption / 24 hours at the 1st day postoperative

    Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative

    1st day postoperative

Secondary Outcomes (4)

  • Opioid side effects

    4th post operative day

  • Pain assessment by VAS

    3rd postoperative day

  • Pain assessment by VAS

    2nd postoperative day

  • Pain assessment by VAS

    1st postoperative days

Study Arms (2)

Real tDCS

ACTIVE COMPARATOR

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.

Device: tDCS

Sham tDCS

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

tDCSDEVICE

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

Real tDCS
Sham tDCSDEVICE

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

Sham tDCS

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Khedr EM, Sharkawy ESA, Attia AMA, Ibrahim Osman NM, Sayed ZM. Role of transcranial direct current stimulation on reduction of postsurgical opioid consumption and pain in total knee arthroplasty: Double randomized clinical trial. Eur J Pain. 2017 Sep;21(8):1355-1365. doi: 10.1002/ejp.1034. Epub 2017 Apr 25.

    PMID: 28440034DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 31, 2016

First Posted

March 9, 2016

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share