Protocol summary

Summary
This study designed for comparison therapeutic effect of ultrasound guided corticosteroid injection with Hydrodissection, injection without Hydrodissection and wrist splinting on carpal tunnel syndrome. Mild to moderate carpal tunnel syndrome patients referred to Baqiyatallah University of Medical Sciences polyclinic and University of Social Welfare and Rehabilitation Sciences affiliated clinics will enroll. Patients with severe carpal tunnel syndrome and severe dysfunction needing surgical releasing and Patients with history of other therapeutic methods will exclude. One hundred fifty carpal tunnel syndrome patients will randomize to five groups by a computed-generalized randomization list: Injection of 80 mg triamcinolone with 1 ml lidocaine 2% by Hydrodissection method in group one; injection of 40 mg triamcinolone with 1 ml distilled water and 1 ml lidocaine 2% by Hydrodissection method in group two; injection of 2 ml distilled water and 1 ml lidocaine 2% by Hydrodissection method in group three; injection of 40 mg triamcinolone without Hydrodissection method in group four; and wrist splinting in group five. In groups one to four, injections will perform 3 times with 2 week intervals. Efficacy of injections on hand performance, nerve conduction and ultrasound study of median nerve and symptoms severity will evaluate before each injection. Group five patients also followed 6 weeks as control. Collected data will compare in these groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020416485N1
Registration date: 2014-05-04, 1393/02/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-04, 1393/02/14
Registrant information
Name
Reza Salman Roghani
Name of organization / entity
Department of Clinical Sciences, University of Social Welfare and Rehabilitation, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
salman@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ultrasound-Guided Local Steroid Injection with Hydro-dissection on Symptom Severity, Ultrasound and Nerve Conduction Study of Median Nerve in Carpal Tunnel Syndrome Patients: A Randomized Clinical Trial
Public title
Therapeutic Effect of Ultrasound-Guided Local Steroid Injection with Hydro-dissection in Carpal Tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mild to moderate carpal tunnel syndrome patients with no history of surgical and local steroid injection, without age and gender limitation. Exclusion criteria: Patients with severe carpal tunnel syndrome and severe dysfunction that needs surgical median nerve releasing; patients with history of other therapeutic approaches; history of allergy against steroids or triamcinolone; steroid contraindications; history of cardiac arrhythmia; diabetes mellitus; hand surgeries in past 3 months; Arthritis rheumatoid; cervical radiculopathy; thyroid dysfunctions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei St, Mollasadra St, Vanak Sq, Tehran, I.R.Iran.
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
34-13

Health conditions studied

1

Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
upper limb mononeuropathy

Primary outcomes

1

Description
Boston's Questionnaire score
Timepoint
Every two weeks
Method of measurement
Questionnaire score

2

Description
Median nerve ultrasound study
Timepoint
Every two weeks
Method of measurement
Diameter and cross section of median nerve

3

Description
Median nerve conduction study
Timepoint
Every two weeks
Method of measurement
Motor and sensory latency of median nerve

4

Description
Pain Score
Timepoint
Every two weeks
Method of measurement
visual analogue score

Secondary outcomes

empty

Intervention groups

1

Description
Injection of 80 mg triamcinolone with 1 ml lidocaine 2% by Hydrodissection method
Category
Treatment - Other

2

Description
Injection of 40 mg triamcinolone with 1 ml distilled water and 1 ml lidocaine 2% by Hydrodissection method
Category
Treatment - Other

3

Description
Injection of 2 ml distilled water and 1 ml lidocaine 2% by Hydrodissection method
Category
Treatment - Other

4

Description
Injection of 40 mg triamcinolone without Hydrodissection method
Category
Treatment - Other

5

Description
Wrist splinting for 6 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences (USWR) affiliated Clinics
Full name of responsible person
Reza Salman Roghani
Street address
University of Social Welfare and Rehabilitation Sciences (USWR), Daneshjoo BLVD, Evin, Tehran, Iran.
City
Tehran

2

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences Policlinic
Full name of responsible person
Hamidreza Karimi Sari
Street address
Baqiyatallah University of Medical Sciences, Nosrati alley, Sheikh Bahaei St, Mollasadra St, Vanak Sq, Tehran, I.R.Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences (USWR), Deputy of Research
Full name of responsible person
Reza Salman Roghani
Street address
University of Social Welfare and Rehabilitation Sciences (USWR), Daneshjoo BLVD, Evin, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences (USWR), Deputy of Research
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
University of Social Welfare and Rehabilitation Sciences (USWR), Aging Research Center
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences (USWR), Daneshjoo BLVD, Evin, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Reza Salman Roghani
Position
Assistant Professor
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences (USWR), Daneshjoo BLVD, Evin, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
salmanroghani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences Aging Research Center
Full name of responsible person
Hamidreza Karimi Sari
Position
General Practitioner
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences (USWR), Daneshjoo BLVD, Evin, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8126 4354
Fax
+98 21 8126 4354
Email
dr.karimih@yahoo.com
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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