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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
The current stimulation will be applied using 35 squares cm wide sponge electrodes
IRCCS Istituto Ortopedico Rizzoli
Bologna, BO, Italy
Change of pain intensity
Visual Analogic Scale (VAS) From 0 (no pain) to 10 (worst pain). Higher the score, worse the outcome.
Time frame: 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.
Time frame: 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.
Time frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
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.
Time frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
QoL: Short Form 12
Short Form 12
Time frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.