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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Chronic

Intervention / Treatment
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* Device: transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, double blinded randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* The current stimulation will be applied using 35 squares cm wide sponge electrodes<br>|
| Placebo Comparator: Control Group<br>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<br>* The current stimulation will be applied using 35 squares cm wide sponge electrodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| QoL: Short Form 12 | Short Form 12 | Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Chronic pain, Transcranial direct current stimulation