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The comparison of effectiveness of two manual therapy methods on clinical and electrophysiological findings in patients with carpal tunnel syndromes

Protocol summary

Summary
The aim of this study is to examine the effects of two manual therapy methods on patients with carpal tunnel syndrome. In this study, 30 patients with CTS ranging from 18 – 55 years and with positive clinical and electrophysiological findings (mild to moderate severity) included. The participants assigned randomly into two groups. In group 1, patients received TENS, ultrasound, and manual therapy for mechanical interface structures (relaxation techniques for anterior forearm muscles, and stretching of transverse carpal ligaments, tendon glide exercise, and wrist joint mobilization). In group 2, patients received TENS, ultrasound, and manual therapy techniques for nerve mobilization. Treatment was done for 4 weeks, 3 days weekly. The electrophysiological studies and clinical examination consisting of Boston questionnaire, visual analogue scale (VAS), and median nerve tension test (MNTT) were carried out for all patients both before and after the 4 weeks intervention program

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508182851N4
Registration date: 2015-09-25, 1394/07/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-25, 1394/07/03
Registrant information
Name
Mohammad Taghipour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4641
Email address
taghipour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research of Babol University of Medical Sciences
Expected recruitment start date
2015-09-26, 1394/07/04
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of two manual therapy methods on clinical and electrophysiological findings in patients with carpal tunnel syndromes
Public title
Conservative management of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with CTS in the age range of 18 – 55 years from mild to moderate severity, with positive clinical findings and electrophysiological findings (median nerve distal motor latency > 4.2ms and median nerve distal sensory latency > 3.7ms) exclusion criterai: Positive compression test in proximal area, systemic peripheral neuropathy, history of carpal tunnel release, metabolic disorders such as diabetics or thyroid diseases, pregnancy, steroid injection in carpal tunnel, and atrophy of thenar muscles
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
babol University of Medical Sciences
Street address
University sqare,keshavars street
City
Babol
Postal code
Approval date
2015-08-09, 1394/05/18
Ethics committee reference number
Mubabol.REC.1394.103

Health conditions studied

1

Description of health condition studied
carpal tunnel syndrome
ICD-10 code
G56
ICD-10 code description
Carpal tunnel syndrome

Primary outcomes

1

Description
pain intensity
Timepoint
before intervention and at the end of 4 weeks
Method of measurement
using of visual analoge scale (VAS)

2

Description
sensory distal latencies
Timepoint
before intervention and at the end of 4 weeks
Method of measurement
using of EMG device

3

Description
motor distal latencies
Timepoint
before intervention and at the end of 4 weeks
Method of measurement
using EMG device

Secondary outcomes

1

Description
Functional status scale
Timepoint
at the baseline and at the end of 4 weeks
Method of measurement
using of Boston questionnaire

2

Description
Symptome Severity Scale
Timepoint
at the baseline and at the end of 4 weeks
Method of measurement
using of Boston questionnaire

3

Description
median nerve tension
Timepoint
at the baseline and at the end of 4 weeks
Method of measurement
using of median neurodynamic test

Intervention groups

1

Description
Intervention in group 1 (manual therapy directed to mechanical interface structures): we use physical modalities (TENS, US) and various manual therapy techniques for mechanical interface structures including of wrist and finger flexors muscles relaxation, tendon glide exercise, stretching of transverse carpal ligament, and wrist joint mobilization.
Category
Rehabilitation

2

Description
Intervention in group 2 (manual therapy directed to nerve): we use physical modalities (TENS, US) and various manual therapy techniques for median nerve including sliding and tension technique.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol shahid beheshti hospital
Full name of responsible person
Dr. mohammad taghipour
Street address
Shahid beheshti hospital, Keshvari square
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol Uiversity of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Keshavarz street, university square, babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol Uiversity 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
Babol University of Medical Sciences
Full name of responsible person
Dr ghadam ali talebi
Position
Assistant professor of physiotherapy
Other areas of specialty/work
Street address
Keshavars street, university square, babol
City
Babol
Postal code
Phone
+98 11 3219 2033
Fax
Email
gh.talebi@mubabol.ac.irtalebiali2@yahoo.co.in
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr ghadam ali talebi
Position
Assistant professor of physiotherapy
Other areas of specialty/work
Street address
Keshavarz street, university square
City
Babol
Postal code
Phone
+98 11 3219 2033
Fax
Email
gh.talebi@mubabol.ac.irtalebiali2@yahoo.co.in
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr mohammad taghipour
Position
Associated professor of physiotherapy
Other areas of specialty/work
Street address
Faculty of medicine, Babol university of Medical Sciences, Babol
City
Babol
Postal code
Phone
+98 11 3219 2033
Fax
Email
taghipourm@yahoo.comtaghipour@mubabol.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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