Ignite Creation Date:
2024-05-06 @ 1:40 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04092088
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2019-07-13
Brief Title:
Effects of Cerebral Peripheral Electrical Stimulation on Pain and Function in CTS
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Effectiveness of Cerebral and Peripheral Electrical Stimulation on Pain and Functional Limitations Associated With Carpal Tunnel Syndrome A Randomized Double-blind Multi-center Factorial Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCS-ENS-CTS
Brief 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
Detailed Description:
The study will be carried out on patients attending 1 Physical Medicine Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital Ismailia EGYPT 2 Hiroshima University 3 Department of Physical Medicine Rehabilitation Juan Ramón Jiménez University Hospital Huelva Spain and 4 University of Sherbrooke Canada and diagnosed with CTS according to clinical examination and to the American Association of Neuromuscular and Electrodiagnostic Medicine AANEM practice recommendations for CTS
Study subjects will be divided into four groups
Group 1 active comparator tDCS-real r TENS-r will include 45 patients with CTS and will receive active anodal tDCS of M1 for 20 minutes at 2 mA plus active TENS the cathode will be placed on the carpal ligament and the anode electrodes on the palmar area of the hand for 20 minutes and a total of 15 sessions for 3 weeks 5 per week will be completed
Group 2 experimental group tDCS-r TENS-sham s will include 45 patients with CTS and will receive active tDCS M1 for 20 minutes plus sham TENS for 20 minutes and a total of 15 sessions for 3 weeks 5 per week
Group 3 experimental group tDCS-s TENS-r will include 45 patients with CTS and will receive sham tDCS M1 for 20 minutes the set will be turned off after 30 seconds plus active TENS for 20 minutes and a total of 15 sessions for 3 weeks 5 per week
Group 4 sham comparator tDCS-s TENS-s will include 45 patients with CTS and will receive sham tDCS M1 for 20 minutes the set will be turned off after 30 seconds plus sham TENS for 20 minutes and a total of 15 sessions for 3 weeks 5 per week
The study sample will be collected from all patients with CTS fulfilling the eligibility criteria will be eligible to join the study either referred for electrophysiological study or presented to the clinic for primary assessment To make sure that no bias should enter the assessment of the results neither the patient nor the clinicians will be aware whether active tDCSTENS will be applied to a particular case To ensure this result one symbol of these four symbols square circle star and triangle will be applied to one group of the four groups in the physiotherapy sheet and only the physiotherapist knew the key for each symbol At the end of the study the four groups will be revealed in order to analyze the results according to proper statistical measures
Study subjects will be divided into four groups
Group 1 active comparator tDCS-real r TENS-r will include 45 patients with CTS and will receive active anodal tDCS of M1 for 20 minutes at 2 mA plus active TENS the cathode will be placed on the carpal ligament and the anode electrodes on the palmar area of the hand for 20 minutes and a total of 15 sessions for 3 weeks 5 per week will be completed
Group 2 experimental group tDCS-r TENS-sham s will include 45 patients with CTS and will receive active tDCS M1 for 20 minutes plus sham TENS for 20 minutes and a total of 15 sessions for 3 weeks 5 per week
Group 3 experimental group tDCS-s TENS-r will include 45 patients with CTS and will receive sham tDCS M1 for 20 minutes the set will be turned off after 30 seconds plus active TENS for 20 minutes and a total of 15 sessions for 3 weeks 5 per week
Group 4 sham comparator tDCS-s TENS-s will include 45 patients with CTS and will receive sham tDCS M1 for 20 minutes the set will be turned off after 30 seconds plus sham TENS for 20 minutes and a total of 15 sessions for 3 weeks 5 per week
The study sample will be collected from all patients with CTS fulfilling the eligibility criteria will be eligible to join the study either referred for electrophysiological study or presented to the clinic for primary assessment To make sure that no bias should enter the assessment of the results neither the patient nor the clinicians will be aware whether active tDCSTENS will be applied to a particular case To ensure this result one symbol of these four symbols square circle star and triangle will be applied to one group of the four groups in the physiotherapy sheet and only the physiotherapist knew the key for each symbol At the end of the study the four groups will be revealed in order to analyze the results according to proper statistical measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None