Effects of Transcranial Direct Current Stimulation on Pain Control in Chronic Painful Total Knee Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pain, Chronic
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Single center, double blinded randomized controlled trialMasking: Double (Participant, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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) patie...
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.
Tracking Information
- NCT #
- NCT04579952
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Roberta Bardelli, MD IRCCS Istituto Ortopedico Rizzoli
Get Well Soon