Effects of Transcranial Direct Current Stimulation on Pain Control in Chronic Painful Total Knee Arthroplasty

Pain, Chronic Clinical Trial

— TSEF-PTG  

Official title:

Effects of Transcranial Direct Current Stimulation (tDCS) and Exercise Versus Sham tDCS and Exercise on Pain Control in Chronic Painful Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579952
• Other study ID #: 687-2019-Disp-IOR
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Roberta Bardelli, MD
• Phone: +390516366359
• Email: roberta.bardelli[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The TSEF-PTG study is a single center, double blinded randomized controlled trial.

The aim is to evaluate the effects of a tDCS stimulation and exercise vs sham tDCS and exercise on pain control in chronic (lasting more than 3 months from the intervention) painful total knee arthroplasty (TKA) patients.

The participants will be randomized in two groups: intervention group (IG) and control group (CG).

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.

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.

The participants will be evaluated at T0 (enrolling), T1 (at the end of the program), T2 (at 1 month from the end of the program) and T3 (at 3 months from the end of the program).

The primary outcome is the variation of pain intensity, the secondary outcomes are the variation of knee function and of the quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Device:
• transcranial Direct Current Stimulation
The current stimulation will be applied using 35 squares cm wide sponge electrodes

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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. — View Citation

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 — View Citation

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 J — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. do — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Knee function	Knee Society Score (KSS) Knee score 0-100, higher the score, better the characteristics of the knee. Function score 0-100, if score <60 poor function, if score 60-69 fair function, if score 70-79 good function, if score 80-100 excellent function. Higher the score better the knee function.	Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
Secondary	QoL: Short Form 12	Short Form 12	Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)