Protocol summary

Summary
This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of topical linseed oil on patients with pregnancy-related carpal tunnel syndrome. Sixty hands with pregnancy-related CTS aged between 18-45 with gestational age 20-32 wk, after taking signed informed consent, according to the electrodiagnosis classification criteria with clinical picture correlated with CTS, are included in this trial. The main exclusion criteria included: recurrent carpal tunnel syndrome; Positive history of trauma or fracture of wrist bones, surgical release of median nerve, direct injection into carpal tunnel of wrist; Evidence of cervical radiculopathy in EMG; Systemic disease including neuropathies (rule out by nerve conduction study of ulnar nerves), collagen vascular diseases such as SLE, scleroderma and RA; Endocrine disease such as hypothyroidism, DM, and other disease-inducing neuropathy; Situations such as renal failure, alcoholism or poor medical condition; History of recent and ongoing use of corticosteroids or analgesics that could not be discontinued. 60 hands wih approved cts will allocate to two arms by using blocked randomization.for the patients in the intervention group the linseed oil products with the size of a pea (depending on the size of the patient, so that the area is completely covered) and 3 times a day (morning, afternoon and night), for use in wrist palmar area, without additional massage is prescripted. The control group will receive placebo with the same method for a period of 4 weeks. Boston questionnaire score for CTS and electrodiagnostic criteria, at the beginning time and after 4 weeks of trial, will be evaluated, by a single researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110224832N1
Registration date: 2015-11-27, 1394/09/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Maryam Nasiri asl
Name of organization / entity
Fasa university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 0994
Email address
m.nasiri@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Fasa University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of topical linseed oil on patients with pregnancy-related carpal tunnel syndrome
Public title
Efficacy of topical linseed oil on patients with pregnancy-related carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
nclusion criteria: pregnancy-related carpal tunnel syndrome; patients aged between 18-45 years old; electrodiagnostic criteria for mild to severe CTS; patient's written informed consent for inclusion; having at least two signs or one sign plus one symptom of: paresthesias, numbness, tingling, night pain positive Phalen test, positive Tinnel test, positive compression test. Exclusion criteria: recurrent carpal tunnel syndrome; positive history of trauma and/or fracture of wrist bones and/or surgical release of median nerve and/or direct injection into carpal tunnel of wrist; evidence of cervical radiculopathy in EMG; systemic disease including: neuropathies (rule out by nerve conduction study of ulnar nerves) and/or collagen vascular diseases such as SLE and scleroderma and RA; endocrine diseases such as hypothyroidism and DM; other disease-inducing neuropathy; situations such as renal failure and/or alcoholism and/or poor medical condition; History of recent and ongoing use of corticosteroids or analgesics that could not be discontinued; hypersensitivity to the drug or placebo; inability to completion of data gathering forms (cognitive or language disorder).
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences, Ebne Sina square
City
Fasa
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
IR.FUMS.REC.1394.27

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
Boston Carpal Tunnel Questionnaire score
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Boston Carpal Tunnel Questionnaire

Secondary outcomes

1

Description
Median nerve sensory distal latency
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Electrodiagnosis

2

Description
Median nerve wrist sensory nerve conduction velocity
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Electrodiagnosis

3

Description
Median nerve motor distal latency
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Electrodiagnosis

4

Description
Median nerve compound latency
Timepoint
At the beginning of the study and after 4 weeks
Method of measurement
Electrodiagnosis

Intervention groups

1

Description
Linseed oil products,with the size of a pea (depending on the size of the patient, so that the area is completely covered) and 3 times a day (morning, afternoon and night), for use in wrist palmar area, without additional massage for 4 weeks
Category
Treatment - Drugs

2

Description
Base of moisturizing gel, with the size of a pea (depending on the size of the patient, so that the area is completely covered) and 3 times a day (morning, afternoon and night), for use in wrist palmar area, without additional massage for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr clinic
Full name of responsible person
Dr. Fereshteh Kalhori
Street address
Valiasr hospital, Ebne sina square
City
Fasa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Ehsan Bahramali
Street address
Fasa University of Medical Sciences, Ebne Sina square
City
Fasa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Alireza Askari
Position
Assistant professor of orthopaedics
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebne Sina square
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
Email
aaskari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempur
Position
PhD of traditional Medicine
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebne Sina square
City
Fasa
Postal code
Phone
+98 71 5335 0994
Fax
Email
hashempur@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Maryam Nasiri Aasl
Position
Medical student
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebne Sina square
City
Fasa
Postal code
Phone
Fax
Email
m.nasiri@fums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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