Effects of Transcranial Direct Current Stimulation on Pain Control in Chronic Painful Total Knee Arthroplasty (TSEF-PTG)

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

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

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.

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.

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.

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.

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

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.

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.

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.

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

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