Effects of Transcranial Direct Current Stimulation on Pain Control in Chronic Painful Total Knee Arthroplasty (TSEF-PTG)
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| ClinicalTrials.gov Identifier: NCT04579952 |
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Recruitment Status :
Enrolling by invitation
First Posted : October 8, 2020
Last Update Posted : March 31, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Chronic | Device: transcranial Direct Current Stimulation | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 54 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Single center, double blinded randomized controlled trial |
| Masking: | 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 |
| 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) |
| Actual Study Start Date : | January 11, 2021 |
| Estimated Primary Completion Date : | September 30, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Group
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.
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Device: transcranial Direct Current Stimulation
The current stimulation will be applied using 35 squares cm wide sponge electrodes |
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Placebo Comparator: Control Group
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.
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Device: transcranial Direct Current Stimulation
The current stimulation will be applied using 35 squares cm wide sponge electrodes |
- Change of pain intensity [ Time Frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3) ]Visual Analogic Scale (VAS) From 0 (no pain) to 10 (worst pain). Higher the score, worse the outcome.
- Change of pain characteristics [ Time Frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3) ]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.
- Change of neuropathic pain presence [ Time Frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3) ]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 function [ Time Frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3) ]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.
- QoL: Short Form 12 [ Time Frame: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3) ]Short Form 12
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579952
| Italy | |
| IRCCS Istituto Ortopedico Rizzoli | |
| Bologna, BO, Italy, 40136 | |
| Principal Investigator: | Roberta Bardelli, MD | IRCCS Istituto Ortopedico Rizzoli |
Other Publications:
| Responsible Party: | Istituto Ortopedico Rizzoli |
| ClinicalTrials.gov Identifier: | NCT04579952 |
| Other Study ID Numbers: |
687-2019-Disp-IOR |
| First Posted: | October 8, 2020 Key Record Dates |
| Last Update Posted: | March 31, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Total knee arthroplasty Chronic pain Transcranial direct current stimulation |
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Chronic Pain Pain Neurologic Manifestations |