The practical purpose of this study is that in the future, clemastine can be used as a suitable drug treatment to improve the symptoms of carpal tunnel syndrome patients.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3 on 20 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Physical medicine clinic of Firouzgar Hospital
meeting the inclusion criteria , obtaining informed consent, the patients are assigned to two groups of cases and controls based on computer randomization. All patients take apparently similar treatment and will not know whether they are in the control group or the sample group.
Participants/Inclusion and exclusion criteria
Complaint of pain or paresthesia distal to the wrist, or loss of sensation or weakness of thenar muscles - which is accompanied by one of the two positive specific examinations for Carpal tunnel syndrome(CTS) (Tinel, Phalen)
No clinical evidence of radicular pain or cervical radiculopathy
No history of CTR surgery
The patient's willingness to participate in the research project
Not receiving injections near the carpal tunnel in the last 3 months
Absence of contraindications to the use of clemastine, such as sensitivity to antihistamines
Intervention groups
Therapeutic intervention in the Case group: use of 1 mg clemastine tablets every night along with CTS split for three months,
Control group: use of a placebo tablet without active pharmaceutical ingredient, consisting of starch and with an appearance completely similar to the drug, taken every night for three months along with the same splint as the Case group. The prescribed splint for all study patients is the same type of Prefabricated volar cockup wrist splint
Main outcome variables
VAS pain score
Median SNAP Amp.
Median SNAP Latency
Median CMAP Amp.
Median CMAP Onset Latency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190428043404N2
Registration date:2023-04-23, 1402/02/03
Registration timing:prospective
Last update:2023-04-23, 1402/02/03
Update count:0
Registration date
2023-04-23, 1402/02/03
Registrant information
Name
Golam Reza Raissi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
raissi.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Clemastine effects on clinical and electrodiagnostic parameters in Carpal tunnel syndrome (CTS) patients: A double blind RCT
Public title
Evaluation of Clemastine effects in CTS pateints
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain or paresthesia or hypoesthesia in distal hand region or thenar weakness, with positive tinel or phalen tests
No clinical evidence of cervical radiculopathy or radicular pain
Negative history for Carpal Tunnel Release (CTR) surgery
No injection inside or in proximity of carpal tunnel in last 3 months
No present contraindication for Clemastine, such as drug allergy to antihistamine group
Patient is willing to knowingly participate in a clinical trial
Exclusion criteria:
Patient isn't cooperative for questionnaire completion
Drug or alcohol addiction
Major depressive disorder or uncontrolled psychiatric disorders
Positive history for malignancy or infection in wrist or hand region
History of ischemic or neurovascular injury in wrist or hand region
Usage of other treatment measures during trial period
Patient doesn't follow correct treatment plan regarding drug or splint usage
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to case and control groups based on computer randomization. The group matching method will be used to control confounding variables (age and gender, body mass index) in two groups.
Also, for the purpose of allocation concealment, the assignment of patients to two control and sample groups will be done randomly by someone other than the researcher, and until after the end of the treatment and the analysis, the patient and the therapist will not know the type of treatment (drugs or placebo)
Blinding (investigator's opinion)
Double blinded
Blinding description
Regarding the double-blindness of this study, it should be noted that all patients receive apparently similar treatment (completely identical appearance and prescription for placebo and drug) and despite the patient's knowledge of the study and the possibility of receiving a placebo, being in the control group or the sample group will not be known to patients.
In order to blind the Assessor, the therapist and the main analyst will not know about the group assigned to each patient, and the delivery of the drug or placebo to the patient will be the responsibility of another person.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran university of medical sciences, School of Medicin
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.IUMS.FMD.REC.1401.477
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Patient's pain intensity(Visual Analogue Scale)
Timepoint
Before, after one month and after three months of intervention
Method of measurement
Using the Visual Analogue Scale
2
Description
Median nerve sensory action potential amplitude
Timepoint
Before, after one month and after three months of intervention
Method of measurement
Nerve conduction study
3
Description
Median nerve sensory action potential latency
Timepoint
Before, after one month and after three months of intervention
Method of measurement
Nerve conduction study
4
Description
Median nerve motor action potential latency
Timepoint
Before, after one month and after three months of intervention
Method of measurement
Nerve conduction study
5
Description
Median nerve motor action potential amplitude
Timepoint
Before, after one month and after three months of intervention
Method of measurement
Nerve conduction study
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 mg clemastine tablet every night along with CTS night splint (Volar cockup wrist splint, Prefabricated) for three months.
Category
Treatment - Drugs
2
Description
Control group: Taking a placebo tablet without active pharmaceutical ingredient (placebo) consisting of starch and with an appearance completely similar to the original drug, every night for three months along with a splint similar to the Case group.