NCT04579952

Brief Summary

The TSEF-PTG study aims to evaluate the effects of transcranial Direct Current Stimulation (tDCS) and exercise versus sham tDCS (placebo) and exercise on pain control in chronic painful total knee arthroplasty (TKA) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

September 23, 2020

Last Update Submit

February 14, 2025

Conditions

Pain, Chronic

Keywords

Total knee arthroplastyChronic painTranscranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

  • Change of pain intensity

    Visual Analogic Scale (VAS) From 0 (no pain) to 10 (worst pain). Higher the score, worse the outcome.

    Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)

  • Change of pain characteristics

    Pain detect questionnaire (PD-Q) From 0 to 38. 0-12 more than 75% chance of presence of nociceptive pain. 13-18 uncertain neuropathic pain presence. 19-38 more than 90% chance of neuropathic pain presence. Higher the score, higher the chance of neuropathic pain presence versus nociceptive pain presence.

    Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)

  • Change of neuropathic pain presence

    Douleur Neuropathique 4 (DN4) scale From 0 to 10. If score \> 4: neuropathic pain presence. Higher the score, higher the chance of neuropathic pain presence.

    Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)

Secondary Outcomes (2)

  • Knee function

    Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)

  • QoL: Short Form 12

    Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)

Study Arms (2)

Intervention Group

EXPERIMENTAL

The IG will receive a 20 minute program of active tDCS (2mA intensity, anode placed on primary motor cortex controlateral to the TKA, cathode placed on controlateral supraorbital region) followed by a 30 minute exercise program, 5 days a week, for 2 consecutive weeks.

Device: transcranial Direct Current Stimulation

Control Group

PLACEBO COMPARATOR

The CG will receive a 20 minute program of sham tDCS (15 seconds of activation and then no stimulation, same position of IG) followed by the same 30 minute exercise program, 5 days a week, for 2 consecutive weeks.

Device: transcranial Direct Current Stimulation

Interventions

transcranial Direct Current StimulationDEVICE

The current stimulation will be applied using 35 squares cm wide sponge electrodes

Control GroupIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent
  • able to independently walk (with or without walk aids)
  • chronic painful TKA (more than 3 months)
  • Visual Analogic Scale for pain more than 3/10
  • No cognitive impairments (MMSE\>24 or =24/30)

You may not qualify if:

  • intracranial metal devices, pacemakers or any implantable devices
  • cutaneous abnormalities on the stimulation sites
  • epilepsy (past or present)
  • neurological or psychiatric pathologies
  • cognitive impairment (MMSE\<24/30)
  • no opioids abuse (past or present)
  • severe cardiopulmonary, renal or hepatic pathologies
  • pregnancy
  • known present TKA complications (e.g. infections, mobilization, etc...)
  • pain therapy modifications in the last 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (13)

  • Kim DH, Pearson-Chauhan KM, McCarthy RJ, Buvanendran A. Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty. J Arthroplasty. 2018 Nov;33(11):3372-3378. doi: 10.1016/j.arth.2018.07.028. Epub 2018 Aug 4.

    PMID: 30143334BACKGROUND

  • Liu SS, Buvanendran A, Rathmell JP, Sawhney M, Bae JJ, Moric M, Perros S, Pope AJ, Poultsides L, Della Valle CJ, Shin NS, McCartney CJ, Ma Y, Shah M, Wood MJ, Manion SC, Sculco TP. A cross-sectional survey on prevalence and risk factors for persistent postsurgical pain 1 year after total hip and knee replacement. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):415-22. doi: 10.1097/AAP.0b013e318251b688.

    PMID: 22660483BACKGROUND

  • Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.

    PMID: 20798443BACKGROUND

  • Baert IA, Lluch E, Mulder T, Nijs J, Noten S, Meeus M. Does pre-surgical central modulation of pain influence outcome after total knee replacement? A systematic review. Osteoarthritis Cartilage. 2016 Feb;24(2):213-23. doi: 10.1016/j.joca.2015.09.002. Epub 2015 Sep 14.

    PMID: 26382109BACKGROUND

  • Phillips JR, Hopwood B, Stroud R, Dieppe PA, Toms AD. The characterisation of unexplained pain after knee replacement. Br J Pain. 2017 Nov;11(4):203-209. doi: 10.1177/2049463717719774. Epub 2017 Jul 31.

    PMID: 29123665BACKGROUND

  • O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Mar 16;3(3):CD008208. doi: 10.1002/14651858.CD008208.pub4.

    PMID: 29547226BACKGROUND

  • Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

    PMID: 27866120BACKGROUND

  • Nikolin S, Huggins C, Martin D, Alonzo A, Loo CK. Safety of repeated sessions of transcranial direct current stimulation: A systematic review. Brain Stimul. 2018 Mar-Apr;11(2):278-288. doi: 10.1016/j.brs.2017.10.020. Epub 2017 Oct 31.

    PMID: 29169814BACKGROUND

  • 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: 28440034RESULT

  • Borckardt JJ, Reeves ST, Robinson SM, May JT, Epperson TI, Gunselman RJ, Schutte HD, Demos HA, Madan A, Fredrich S, George MS. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8. doi: 10.1097/AJP.0b013e31827e32be.

    PMID: 23370085RESULT

  • Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.

    PMID: 28665989RESULT

  • Wylde V, Dennis J, Gooberman-Hill R, Beswick AD. Effectiveness of postdischarge interventions for reducing the severity of chronic pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2018 Feb 28;8(2):e020368. doi: 10.1136/bmjopen-2017-020368.

    PMID: 29490967RESULT

  • Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

    PMID: 16427357RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Roberta Bardelli, MD

    IRCCS Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant blinding: sham tDCS is provided by a 15 second activation (to perform initial sensation) and then no stimulation in the same areas and with the same cadence of the real tDCS. Outcomes assessor blinding: the assessor who evaluates the participants doesn't know if the tDCS or sham tDCS will be or were performed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center, double blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 8, 2020

Study Start

January 25, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)