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The comparison of the effect of Cervical spine 5- Cervical spine 7 mobilization with median nerve neurodynamic technique on pain, neck disability index and elbow ROM in patients with cervical radiculopathy.

Protocol summary

Study aim
Objectives : The present study aimed to compare the effectiveness of cervical spine(C5,C6,C7) mobilization with median nuerodynamic technique in the pain relief and Neck Disability Index and elbow range of motion for patients with cervical radiculopathy.
Design
Design: This study is an double blinded interventional clinical trial .36 patients with cervical radiculopathy randomly allocated to 3 different groups. This study was carried out in physical therapy clinics affiliated to Shiraz University of Medical Sciences.
Settings and conduct
In the clinic of Shiraz Faculty of Rehabilitation Sciences
Participants/Inclusion and exclusion criteria
36 patients with cervical radiculopathy Inclusion criteria: 35-50 years old, median nerves involved for at most 4 months, symptoms of pain radiating into the arm and C5, C6 and C7 roots involved. Exclusion criteria: patients with radial and ulna nerve involvement, patients with neck pain alone or arm pain alone, carpal tunnel syndrome.
Intervention groups
The patients in group A received mobilization technique and electrical stimulation and heat therapy, in group B received median nerve neurodynamic technique, and electrical stimulation and heat therapy ,in group C received electrical stimulation and heat therapy for 20 minutes, respectively.
Main outcome variables
main outcome measures: The mean neck pain intensity , neck disability ,The mean range of motion (ROM) of elbow extension , the F-wave from flexor carpi radialis to evaluate function of median nerve.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120411009440N21
Registration date: 2019-04-30, 1398/02/10
Registration timing: retrospective

Last update: 2019-04-30, 1398/02/10
Update count: 0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Soraya Pirouzi
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
piroozis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
shiraz university of medical science
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of Cervical spine 5- Cervical spine 7 mobilization with median nerve neurodynamic technique on pain, neck disability index and elbow ROM in patients with cervical radiculopathy.
Public title
The comparison of the effect of C5-C7 mobilization with median nerve neurodynamic technique on pain, neck disability index and elbow ROM in patients with cervical radiculopathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 35-50 history of median nerve involvement at most 4 months with no manual therapy C5 - C6 - C7 root involvement with radicular pain to arm at least three positive tests out of four: spurling test, distruction test, upper limb tention test (ULTT), neck rotation under 60 degree
Exclusion criteria:
any history of trauma neck and upper limb inflammation rheumatic disease severe osteoporosis tumor and cancer of head and neck and upper limbs neck and upper limb hypermobility patient with taking analgesic drugs radial and ulna nerve involvement neck pain alone or arm pain alone cognitive disorders carpal tunnel syndrome ( CTS)
Age
From 35 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random number table are used to allocate individuals to groups.
Blinding (investigator's opinion)
Not 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 Blvd., Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2014-08-26, 1393/06/04
Ethics committee reference number
IR.SUMS.REC.1393.S6984

Health conditions studied

1

Description of health condition studied
cervical radiculopathy
ICD-10 code
G54.2
ICD-10 code description
Cervical root disorders, not elsewhere classified

Primary outcomes

1

Description
Neck pain
Timepoint
before and after of treatment
Method of measurement
numerical pain rating scale

2

Description
Neck disability
Timepoint
before and after of treatment
Method of measurement
Neck disability index

Secondary outcomes

1

Description
passive range of motion (degrees) elbow extention
Timepoint
before and after of treatment
Method of measurement
Goniometer

2

Description
F wave parameter
Timepoint
before and after of treatment
Method of measurement
electromyography Sapphire 2 model made in england

Intervention groups

1

Description
Group A cervical mobilization( C5-C7) 60 seconds with three repetitions, electrical stimulation and heat therapy for 20 minutes for 5 times a week
Category
Treatment - Other

2

Description
Group B median nerve neurodynamic technique in 10 seconds, electrical stimulation and heat therapy for 20 minutes for 5 times a week
Category
Treatment - Other

3

Description
Electrotherapy (electrical stimulation and heat therapy) for 20 minutes, 5 times a week
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Medicine clinic of Shiraz university
Full name of responsible person
Saeede Sarvari
Street address
Abiverdi1 street
City
Shiraz
Province
Fars
Postal code
6361918116
Phone
+98 61 5272 6853
Email
sarvari_sa50@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyyed Bashir Hashemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
6361989413
Email
sarvari_sa50@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz
Full name of responsible person
Soraya Piroozi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Abiverdi 1 Ave
City
Shiraz
Province
Fars
Postal code
7186734166
Phone
+98 71 3627 1552
Fax
Email
piroozis@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soraya Piroozi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abivardi1 street
City
Shiraz
Province
Fars
Postal code
7186734166
Phone
+98 71 3627 1552
Fax
Email
piroozis@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeede Sarvari
Position
Ms student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Abiverdi1
City
Shiraz
Province
Fars
Postal code
6361918116
Phone
+98 61 5272 6853
Fax
Email
sarvari_sa50@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The comparison of the effect of C5-C7 mobilization with median nerve neurodynamic technique on pain, neck disability index and elbow ROM in patients with cervical radiculopathy.
When the data will become available and for how long
23 july until 21september
To whom data/document is available
researcher
Under which criteria data/document could be used
study and research
From where data/document is obtainable
shiraz school of rehabilitation sciences
What processes are involved for a request to access data/document
therapeutic
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