| CTRI Number |
CTRI/2021/04/033084 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
20/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of pregabalin in carpal tunnel syndrome |
|
Scientific Title of Study
|
Effectiveness of pregabalin in treatment of carpal tunnel syndrome: A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RAMESHWAR NATH CHAURASIYA |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE IF MEDICAL SCIENCE,BHU |
| Address |
DEPARTMENT OF NEUROLOGY
INSTITUTE OF MEDICAL SCIENCE
BANARAS HINDU UNIVERSITY
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415353255 |
| Fax |
|
| Email |
goforrameshwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMESHWAR NATH CHAURASIYA |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE IF MEDICAL SCIENCE,BHU |
| Address |
DEPARTMENT OF NEUROLOGY
INSTITUTE OF MEDICAL SCIENCE
BANARAS HINDU UNIVERSITY
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415353255 |
| Fax |
|
| Email |
goforrameshwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KUMAR BISMAYA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF NEUROLOGY
INSTITUT OF MEDICAL SCIENCES, BHU, VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7205142590 |
| Fax |
|
| Email |
kumar.bismaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF MEDICAL SCIENCES,BHU,VARANASI |
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF MEDICAL SCIENCES BHU VARANASI |
| Address |
DEPARTMENT OF NEUROLOGY
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
VARANASI |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| La Renon Healthcare Pvt Ltd |
La Renon Corporate House, Behind Rajpath Club, Kensville Road, Opp. Infostretch Building, Off S.G. Highway, Ahmedabad, Gujarat 380059 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RAMESHWAR NATH CHAURASIYA |
INSTITUTE OF MEDICAL SCIENCES, BHU |
DEPARTMENT OF NEUROLOGY
INSTITUTE OF MEDICAL SCIENCES, BHU, VARANASI
Varanasi
UTTAR PRADESH |
9415353255
goforrameshwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PLACEBO |
Similar appearing placebo capsule are given once daily for 1 week followed by twice daily for 1 week followed by thrice daily for 6 weeks (total 8 weeks) |
| Intervention |
PREGABALIN |
Capsule PREGABALIN 50 mg once daily for 1 week followed by twice daily for 1 week followed by thrice daily for another 6 weeks (total 8 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with symptoms & signs of CTS(idiopathic) with at least one of the following electrophysiological features-
A.Difference in Median and Ulnar sensory peak Latency>0.5ms
B.Difference in Median and Ulnar motor distal latency >0.5ms
C.Median sensory latency ≥3.6ms
D.Median motor distal Latency ≥4.5ms
|
|
| ExclusionCriteria |
| Details |
A.Severe CTS with thenar atrophy
B.Previously operated for release of Carpal Tunnel or local steroid injection
C.Secondary causes of CTS like Diabetes mellitus, rheumatoid arthritis, hypothyroidism, amyloidosis and post-traumatic
D.Patients with other neurological causes like polyneuropathies, thoracic outlet syndrome, cervical radiculopathy
E.Patients in whom ultrasound reveal secondary causes of carpal tunnel syndrome like Ganglion cysts, accessory muscles etc
F.Not willing to participate/give consent
G.Pregnant or breast feeding women
H. Clinically significant cardiovascular, renal or hepatic disease
I. Patients on pregabalin for other casuse like seizure disorder, trigeminal neuralgia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in BCTQ(Boston Carpal Tunnel Questionnaire) subscale score
A. SSS(Symptom Severity Score)
B. FSS(Functional Status Score) |
baseline,2 weeks,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in clinical grading of CTS |
Baseline, 8 week |
| Change in Electro-physiological grading of CTS |
Baseline, 8 week |
| Change in grip strength by hydraulic hand dynamometer |
Baseline, 2 week, 8 week |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "146"
Final Enrollment numbers achieved (India)="146" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/04/2021 |
| Date of Study Completion (India) |
25/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Carpal tunnel syndrome(CTS) is a chronic compressive neuropathy that is caused by median nerve entrapment in the carpal tunnel and is the most common entrapment neuropathy. The incidence of CTS in general population is approximately 1 in 1000. The prevalence of the disease is 5.3% in women and 2.1% in men. Risk factors for the development of CTS is obesity, pregnancy, diabetes, hypothyroidism, rheumatoid arthritis, trauma etc. Carpal tunnel is a osteo-fibrous canal that contains 9 flexor tendons and median nerve. CTS is manifested by paresthesia, numbness, tingling, pain( nocturnal), weakness or thenar atrophy. It is critical to begin treatment in early phase of CTS before the damage process. Treatment modalities include conservative management which includes oral analgesics, splinting in mild to moderate CTS. Tropical steroid injection and decompressive surgery is also advised in severe CTS. Surgery is also indicated when sign and symptoms of CTS are persistent and interferes with quality of life. Gabapentin and pregabalin are proposed for the treatment of neuropathic pain like diabetic neuropathy, herpetic neuralgia or trigeminal neuralgia. Gabapentin use is shown to be safe and effective in CTS but at a very high dose 900-1800 mg /day which can have some side effects or intolerable for some patients. Though pregabalin is also commonly used for various causes of neuropathic pain can be used in CTS. But there is no pregabalin vs placebo or pregabalin vs gabapentin comparision to suggest superiority of one over other. |