Protocol summary

Summary
The aim of this study is to evaluate the efficacy of tendon/nerve gliding exercises in conservative management of carpal tunnel syndrome (CTS). 40 hands with clinical and electrodiagnostic diagnosis of mild to moderate CTS will be enrolled in the study. Patients will be randomly divided into 2 groups: control and experimental groups. Patients in control group will receive only standard treatment of CTS (static wrist splint in neutral wrist joint position). Patients in experimental group will receive tendon/nerve gliding exercises as well as standard treatment of CTS. At baseline and 6 weeks later patients are going to be evaluated in regard of pain intensity, physical examination findings, electodiagnostic findings, and functional status.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092612450N1
Registration date: 2014-03-17, 1392/12/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Aref Nasiri Sheikhdarabadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 9040
Email address
nasirisha@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-12-31, 1391/10/11
Expected recruitment end date
2013-04-30, 1392/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Tendon/Nerve gliding exercises in management of carpal tunnel syndrome and electrodiagnostic evaluation
Public title
Tendon/Nerve gliding exercises in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with clinical signs and symptoms of CTS who confirmed to have mild to moderate CTS by electrodiagnostic criteria were included in the study. Exclusion criteria: 1-patients with secondary CTS (those having diabetes, rheumatoid arthritis or other joint diseases, trauma, metabolic disorders); 2- patients with joints disorder; 3-patients with severe CTS and muscular atrophy; 4-patients with history of carpal tunnel release surgery; 5-extremes of ages (children and elderly); 6-patients with signs of upper motor neuron diseases or peripheral neuropathy
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street Shiraz Fars Iran, Islamic Republic Of
City
Shiraz
Postal code
Approval date
2013-02-12, 1391/11/24
Ethics committee reference number
CT-P-91-4618

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
functional status of hand
Timepoint
Six weeks after begining of treatment
Method of measurement
Boston Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control: Static wrist splint set in neutral wrist joint position
Category
Treatment - Devices

2

Description
Experimental group: tendon-gliding exercises, the fingers are placed in 5 different positions including straight, hook, fist, table top, and straight fist. Median nerve-gliding exercise, the median nerve is mobilized by putting the hand and wrist in 6 discrete positions. Each position was maintained for 5 seconds. The exercises were applied as 3 sessions daily. Each exercise was repeated 10 times at each session.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical medicine and rehabilitation clinic of shahid chamran hospital.
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Hatam Gholamreza, Vice chancellor for Research of Shiraz University of medical sciences
Street address
Zand street, Central Building of Shiraz University of Medical Sciences Shiraz Fars Iran, Islamic Republic Of
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz 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
Shiraz University of Medical Scienses
Full name of responsible person
Aref Nasiri
Position
MD, resident of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shiraz
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
nasirisha@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Mohamadreza Emad
Position
Associate professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shiraz,Zand street,shahid faghihi hospital, Department of physical medicine and rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
emadm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Aref Nasiri
Position
MD, resident of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shiraz, zandi street, shahid faghihi hospital, Department of physical medicine and rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
nasirisha@sums.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
Loading...