Evaluation of the effectiveness of wrist mobilization compared with local corticosteroide injection in treatment of moderate carpal tunnel syndrome
Design
Two arm parallel group randomized trial with blinded outcome assessment
Settings and conduct
This study was conducted on patients referred to Aja University of Medical sciences in Imam Reza Hospital in 1395-1396.
One of the doctors did not have any knowledge about the treatment provided to patients, and just evaluate the outcome. The other physician and the physiotherapist were only responsible for treating patients without knowing the functional status and severity of the patient's symptoms and pain.
Participants/Inclusion and exclusion criteria
Idiopathic moderate carpal tunnel syndrome approved by electrodiagnostic criteria
Age of 30 to 60 years and with any sex
Intervention groups
This study was single-blind and it was performed on 58 hands with moderate CTS. Patients were randomly divided into two treatment groups with 29 samples. Group one was treated with local corticosteroid injection (40 mg Methylprednisolone acetate + 0.5 cc Lidocaine 2%) in the carpal tunnel. Group two was treated with carpal bone and Median nerve mobilization at wrist for ten sessions, every other day. Both groups received wrist splint with oral medication (Gabapentin tablet 100 mg and Vitamin B6 tablet 40 mg per day) for two month.
Main outcome variables
Electrodiagnostic parameters of Median nerve (sensory and motor latency and amplitude), pain intensity (based on visual analogue scale), symptom severity and functional status (based on Boston carpal tunnel questionnaire) and patient satisfaction.
General information
Reason for update
Acronym
CTS
IRCT registration information
IRCT registration number:IRCT20180511039611N1
Registration date:2018-08-04, 1397/05/13
Registration timing:retrospective
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Hamideh Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
drdehghani.ha@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of wrist mobilization compared with local corticosteroide injection in treatment of moderate carpal tunnel syndrome
Public title
Study of the effect of wrist mobilization on carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Carpal tunnel syndrome approved by electrodiagnostic criteria
Age 30 to 60 years old and with any sex
Exclusion criteria:
Atrophy of tenar muscle, mild or severe CTS based on electrodiagnostic study
patient who was treated with anti-inflammatory drugs or physiotherapy modalities
previous local steroids injection in a recent year or previous surgery for CTS
Inflammatory joint disease, diabetes mellitus, thyroid disease
Polyneuropathy, cervical radiculopathy, myelopathy
Pregnancy
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done through randomized number table for mobilization & local injection groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was conducted by two physicians and one physiotherapist. One of the doctors did not have any knowledge about the treatment provided to patients, and just did the median nerve conduction studies, assessed the pain, severity of symptoms, and functional status. The other physician was only responsible for treating patients without knowing the functional status and severity of the patient's symptoms and pain. Of course, in group two, the physiotherapist who performed manual therapy; had no knowledge about the status of the condition and the severity of the patient's symptoms and pain.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh, West Fatemi St., Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2016-10-03, 1395/07/12
Ethics committee reference number
IR.AJAUMS.REC.1395.16
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
Description
Electrodiagnostic parameters of Median nerve (sensory and motor latency and amplitude)
Timepoint
Before and two months after treatment
Method of measurement
By electrodiagnostic device (Medtronic Dk-2740 denmark)
Secondary outcomes
1
Description
Pain intensity
Timepoint
Before, one and two months after treatment
Method of measurement
By visual analogue scale
2
Description
symptom severity and functional status
Timepoint
Before, one and two months after treatment
Method of measurement
By Boston carpal tunnel questionnaire
3
Description
Patient satisfaction
Timepoint
6 months after treatment
Method of measurement
By telephone
Intervention groups
1
Description
Intervention group two was treated with carpal bone and Median nerve mobilization at wrist for ten sessions, every other day; also received wrist splint with oral medication (Gabapentin tablet 100 mg and Vitamin B6 tablet 40 mg per day) for two month.Intervention group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Sirous Azizi
Street address
Imam Reza Hospital, Aja University of Medical Sciences, Shahid Etemadzadeh, West Fatemi St., Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 4382 3476
Email
drdehghani.ha@Ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Kamran Azma
Street address
Imam Reza Hospital, Aja University of Medical Sciences, Shahid Etemadzadeh, West Fatemi St., Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 4382 3476
Email
drdehghani.ha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Hamideh Dehghani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, Aja University of Medical Sciences, Shahid Etemadzadeh, West Fatemi St., Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 4382 3476
Email
drdehghani.ha@Ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hamideh Dehghani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, Aja University of Medical Sciences, Shahid Etemadzadeh, West Fatemi St., Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 4382 3476
Email
drdehghani.ha@Ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hamideh Dehghani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, Aja University of Medical Sciences, Shahid Etemadzadeh, West Fatemi St., Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 4382 3476
Email
drdehghani.ha@Ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD