Comparison of the effects of neurodynamic mobilization and use of orthosis on median nerve stiffness in patients with carpal tunnel syndrome by sonoelastography
Comparison of the effects of neurodynamic mobilization and use of orthosis on median nerve stiffness in patients with carpal tunnel syndrome by sonoelastography
Design
Randomized Clinical trial with stratified randomization, Including two parallel interventional groups, Single blind
Settings and conduct
After screening CTS patients referred to medical centers affiliated to Shiraz University of Medical Sciences and obtaining informed consent, patients would be evaluated and then randomly assigned to two treatment groups and it will be done in the Faculty of Rehabilitation Sciences of Shiraz University of Medical Sciences. The evaluations will be repeated after the end of the treatment. Assessors will not know how patients are assigned to groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having CTS (Carpal Tunnel Syndrome) according to diagnosis criteria of increased sensory or distal motor latency, Having symptoms of CTS for at least one month;
Exclusion Criteria: History of surgical interventions in wrist area, History of steroid injection for CTS in the studied hand 6 months before the examination, Joint inflammatory disease, If CTS is associated with pregnancy or diabetes
Intervention groups
One group of patients receive neurodynamic mobilization of median nerve for one week, and the other group receives night wrist hand orthosis for one week.
Main outcome variables
Median nerve stiffness, Symptom severity and function, Nerve conduction velocity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160614028447N8
Registration date:2020-09-06, 1399/06/16
Registration timing:prospective
Last update:2020-09-06, 1399/06/16
Update count:0
Registration date
2020-09-06, 1399/06/16
Registrant information
Name
Amin Kordi Yoosefinejad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 1081
Email address
yoosefinejad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of neurodynamic mobilization and use of orthosis on median nerve stiffness in patients with carpal tunnel syndrome by sonoelastography
Public title
Comparison of the effects of nerve mobilization and use of orthosis on median nerve stiffness in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having CTS according to diagnosis criteria of increased sensory or distal motor latency
Having symptoms of CTS for at least one month
Exclusion criteria:
History of surgical interventions in wrist area
Having received intervention related to CTS for three months before the examination
History of steroid injection for CTS in the studied hand 6 months before the examination
Joint inflammatory disease
If CTS is associated with pregnancy or diabetes
Inability to complete questionnaires due to cognitive problems
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization would be performed according to severity of the disease. In each stratum of weak, medium and severe, a separate randomization list is designed, which is based on the permutation block method, and we considered 3 blocks of 4 in each of them. Using random number generator software, random sequences of numbers 0 and 1 are generated and based on that, patients are divided into two treatment groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a one-way blind trial study in which the person performing the sonoelastography evaluation is unaware of the patient's treatment and in order to perform the blinding process, tests and treatments would be done in independent centers and by different people and each of them is unaware of other processes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Sheikh Abivardi 1, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.029
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
Median nerve stiffness
Timepoint
At the beginning of study (before intervention) and at the end of study (after 1 week of intervention)
Method of measurement
Sonoelastography
Secondary outcomes
1
Description
Symptom severity and function
Timepoint
At the beginning of study (before intervention) and at the end of study (after 1 week of intervention)
Method of measurement
Boston Carpal Tunnel Syndrome Questionnaire
2
Description
Nerve conduction velocity
Timepoint
At the beginning of study (before intervention) and at the end of study (after 1 week of intervention)
Method of measurement
Electrodiagnosis
Intervention groups
1
Description
First intervention group: In neurodynamic technique intervention group, treatment will be done using neurodynamic techniques in median nerve in a supine lying position. Neurodynamic sequence will be as follows: 90 degrees arm abduction, arm external rotation, wrist and hand extension, elbow supination and elbow extension. In this sequence, glide and tension techniques will be done in proximal and distal directions: 1- Glide proximal mobilization (high-amplitude extension movement of the elbow joint), 2- Glide distal mobilization (high-amplitude extension movement of the wrist joint), 3- Tension proximal mobilization (low-amplitude extension movement of the elbow joint at end range), 4- Tension distal mobilization (low-amplitude extension movement of the wrist joint). Neurodynamic protocol includes 3 sets of 60 repetitions of neurodynamic techniques of sliding and tension with 15 seconds rest between each set. Each session lasts for 20 minutes. The intervention would be done once daily for a week.
Category
Rehabilitation
2
Description
Second intervention group: In orthosis intervention group, immobilization would be done by a night wrist-hand orthosis in neutral position and the person is asked to wear it every night for 8 hours and continue it for a week. The orthosis is made specifically for each patient and is made of thermoplastic to be able to keep the wrist in exact neutral position.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Amin KordiYoosefinejad
Street address
School of Rehabilitation Sciences, Sheikh Abivardi 1, Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3626 1081
Fax
+98 71 3627 2495
Email
yoosefinejad@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzadeh
Street address
Deputy of Research and Technology, 7th Floor, Central Building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
rezaiana@sums.ac.ir
Grant name
Vice chancellor of research of Shiraz University of Medical Sciences
Grant code / Reference number
99-01-06-22602
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shiraz University of Medical Sciences
Full name of responsible person
Sahar Khademi
Position
Ph.D. candidate in Physical Therapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 62, Kavoosi Ave., Sardaran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
71559-66991
Phone
+98 71 3740 8440
Email
khademi.sahar21@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sahar Khademi
Position
Ph.D. candidate in Physical Therapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 62, Kavoosi Ave., Sardaran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
71559-66991
Phone
+98 71 3740 8440
Email
khademi.sahar21@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sahar Khademi
Position
Ph.D. candidate in Physical Therapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 62, Kavoosi Ave., Sardaran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
71559-66991
Phone
+98 71 3740 8440
Email
khademi.sahar21@gmail.com
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
Not applicable
Title and more details about the data/document
All data except personal information would be available.
When the data will become available and for how long
The start of the access period is 6 months after the acceptance of the article.
To whom data/document is available
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.
Under which criteria data/document could be used
Researchers can use data for advanced analyses or for meta analysis studies.
From where data/document is obtainable
Dr. Amin KordiYoosefinejad, Shiraz, Chamran Blvd., Sheikh Abivardi 1 ave., School of Rehabilitation Sciences, Mobile: 09171950589, E-mail: yoosefinejad@sums.ac.ir
What processes are involved for a request to access data/document
After 6 months from article acceptance, while announcing a written request to the executor of the project to receive information and a precise explanation about how to use the information, an official letter is also requested to obtain permission from the ethics committee to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.