Effects of Cerebral & Peripheral Electrical Stimulation on Pain and Function in CTS (NCT04092088) | Clinical Trial Compass
UnknownNot Applicable
Effects of Cerebral & Peripheral Electrical Stimulation on Pain and Function in CTS
180 participantsStarted 2019-12
Plain-language summary
This is a randomized, double-blind, multi-center, factorial clinical trial to study the effectiveness of cerebral and peripheral electrical stimulation on pain and functional limitations associated with carpal tunnel syndrome (CTS). The study subjects will be randomly into four groups; (1) active trans-cranial direct current stimulation (tDCS) + active trans-cutaneous electrical nerve stimulation (TENS), (2) active tDCS + sham TENS, (3) sham tDCS + active TENS and (4) sham tDCS + sham TENS. The patient will be assessed by Brief Pain Inventory (BPI), Beck Depression Inventory (BDI), The Douleur Neuropathique en 4 questions (DN4), Quantitative sensory testing (QST), Pain Pressure Test (PPT) with algometer, Conditioned pain modulation (CPM), Patient ratings of improvement, or worsening, of the pain condition, Quality of Life short-form (SF)-36, Visual Analog Mood Scale (VAMS), Mini Mental Status Exam (MMSE) and Adverse Events Questionnaire (AEs). This study aims to investigate whether cerebral and peripheral electrical stimulation combined are more effective in relieving pain and functional limitations than the separate application of electrical stimulation in patients with CTS.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females aged \>18 years and \<65 years.
* Paresthesia, pain or vasomotor symptoms through the distribution of median nerve (persistence \> 2 months).
* Positive result for Phalen's, Tinel's and/or carpal compression tests during physical examination.
* Mild-to-moderate severity of CTS according to American Association of Neuromuscular \& Electrodiagnostic Medicine (AANEM) 2002 (mild: abnormal sensory peak latency \[≥3.5ms\] with normal motor distal latency \[\<4.4\]; moderate: abnormal sensory \[≥3.5ms\] and motor \[≥4.4ms\] latencies).
Exclusion Criteria:
* Previous history of wrist surgery
* Presence of predisposing etiological factors for CTS (e.g., diabetes mellitus).
* Trauma, neurological, psychiatric, rheumatic diseases, renal failure, pregnancy, hypothyroidism, and hyperthyroidism.
* Presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy.
* Pharmacological treatment with oral steroids or non-steroidal anti-inflammatory drugs within the previous month.
* Participation in a physical therapy program.
* Administration of steroid injection(s) within the previous 6 months.
* Previous treatment with TENS \<6 months.
* Previous treatment with tDCS.
* Use of pacemakers or other implanted devices.
* Pregnancy or breastfeeding.
* Refuse to participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.