Knee ReplacementTDCSTKANCT02704182
Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty
A study testing tDCS in people with Knee Replacement, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Knee Replacement
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)
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.
Read the detailed 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.
- Conditions
- Knee Replacement
- Being tested
- tDCS, Sham tDCS
- Keywords
- Arthroplasties, Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
Sham tDCSDevice
25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids consumption per 24 hours at the 4th day postoperative
Measuring the consumption dose of opioids per 24 hours at the fourth day
Measured: 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
Measured: 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
Measured: 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
Measured: 1st day postoperative
Secondary outcomes (4)
Opioid side effects
Record Opioid-related adverse effects (nausea and/or vomiting and the need for alizapride 50mg IV).
Measured: 4th post operative day
Pain assessment by VAS
Pain Assessment using Visual Analogue Scale
Measured: 3rd postoperative day
Pain assessment by VAS
Pain Assessment using Visual Analogue Scale
Measured: 2nd postoperative day
Pain assessment by VAS
Pain Assessment using Visual Analogue Scale
Measured: 1st postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M. Khedr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704182
- Sponsor's protocol ID
- tDCS in TKA
- Acronym
- TDCSTKA
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28440034
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT02704182
- Acronym / sponsor ID
- TDCSTKA / tDCS in TKA
- Conditions
- Knee Replacement
- Keywords
- Arthroplasties, Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Active comparator | Device: tDCSDirect current stimulation using anodal electrode, 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days. |
| Sham tDCS | Sham comparator | Device: Sham tDCSSham direct current stimulation, 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days. | Device | Real tDCS |
| Sham tDCS25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days. | Device | Sham tDCS |
Primary outcome
Opioids consumption per 24 hours at the 4th day postoperative
Time frame: day 4 postoperative
Measuring the consumption dose of opioids per 24 hours at the fourth day
Opioids consumption / 24 hours at the third day postoperative
Time frame: day 3 postoperative
Measuring the consumption dose of opioids per 24 hours at the third day postoperative
Opioids Consumption / 24 hours at the second day postoperative
Time frame: day 2 postoperative
Measuring the consumption dose of opioids per 24 hours at the second day post-operative
Opioids consumption / 24 hours at the 1st day postoperative
Time frame: 1st day postoperative
Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative
4 secondary outcomes
Opioid side effects
Time frame: 4th post operative day
Pain assessment by VAS
Time frame: 3rd postoperative day
Pain assessment by VAS
Time frame: 2nd postoperative day
Pain assessment by VAS
Time frame: 1st postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 28440034Khedr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Knee Replacement, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioids consumption per 24 hours at the 4th day postoperative (time frame: day 4 postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.