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Evaluation of changes in electromyography findings before and after treatment in patients with upper extremity radicular pain due to cervical discopathy which has been treated with cervical epidural steroid injection

Protocol summary

Study aim
Evaluation of Electromyographic and clinical findings before and after treatment in patients with radicular upper extremities pain due to cervical discopathy who underwent cervical epidural steroids injections as treatment
Design
The present study is a before and after clinical trial, not blinded, without randomization and phase 2. A total of 40 patients with chronic neck pain will be enrolled.
Settings and conduct
This study will be done in the operating room and clinic.Before and after steroid injection, The clinical characteristics of pain, neuropathic elements and mobility and functional status are evaluated for up to 6 months using different questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic neck pain(more than 3 months), caused by disc herniation or central spinal stenosis, according to the clinical criteria and MRI findings. Exclusion criteria: Age less than 18 years, Prior cervical epidural injections during last year, Prior cervical spinal surgery, All contraindications to steroids or Non-steroidal anti-inflammatory drugs, All contraindications to epidural injections, All red flags for spinal pain (inflammation, malignancy, spinal fracture, myelopathy, cauda equina syndrome), Serious co-morbidities (renal or hepatic failure, severe heart failure, severe respiratory disease, vascular insufficiency ),Critical level of spinal stenosis, Ankylosing spondylitis or other rheumatological diseases, Pregnancy and Patient’s refusal.
Intervention groups
Interlaminar epidural injection of methylprednisolone 40-80 mg combined with bupivacaine 0.2% at a total volume of 6ml, under fluoroscopic guidance at the C4-C5 or C5-C6 level, via an 18G Tuohy epidural needle.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101113005172N5
Registration date: 2023-02-14, 1401/11/25
Registration timing: prospective

Last update: 2023-02-14, 1401/11/25
Update count: 0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Saman Asadi
Name of organization / entity
Anesthesiology ward of Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
asadisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of changes in electromyography findings before and after treatment in patients with upper extremity radicular pain due to cervical discopathy which has been treated with cervical epidural steroid injection
Public title
Evaluation of cervical epidural steroid injection in the Improvement of patients with upper extremity radicular pain due to cervical discopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with chronic neck pain(more than 3 months), caused by disc herniation or central spinal stenosis, according to the clinical criteria and MRI findings
Exclusion criteria:
All red flags for spinal pain (inflammation, malignancy, spinal fracture, myelopathy, Cauda equina syndrome) Serious coexisting neurological or musculoskeletal disorders Serious comorbidities (renal or hepatic failure, severe heart failure, severe respiratory disease, vascular insufficiency ) Rheumatoid arthritis Ankylosing spondylitis or other rheumatological diseases Prior cervical spinal surgery Prior cervical epidural injections during last year All contraindications to epidural injections ( Systemic infection or local infection at the site of injection, bleeding diathesis or full anticoagulation, significant allergic reaction/hypersensitivity to contrast, anesthetic, … ) Critical level of spinal stenosis. All contraindications to steroids or Non-steroidal anti-inflammatory drugs Age less than 18 years Pregnancy Patient’s refusal
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.SUMS.MED.REC.1401.292

Health conditions studied

1

Description of health condition studied
Cervical discopathy
ICD-10 code
M50.10
ICD-10 code description
Cervical disc disorder with radiculopathy, unspecified cervical region

Primary outcomes

1

Description
Pain
Timepoint
10 to 15 days before epidural steroid injection and 1, 3 and 6 months after epidural steroid injection.
Method of measurement
In respect to standardized questionnaire.

2

Description
electromyogram
Timepoint
10 to 15 days before epidural steroid injection and 1, 3 and 6 months after epidural steroid injection.
Method of measurement
In respect to standardized questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Changes in electromyography findings before and after Interlaminar epidural injection (including: methylprednisolone 40-80 mg combined with bupivacaine 0.2% at a total volume of 6ml, under fluoroscopic guidance at the C4-C5 or C5-C6 level, via an 18G Tuohy epidural needle) will be reviewed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Abu-Ali Sina Hospital
Full name of responsible person
Mahsa Tahvili
Street address
No958, Pasdaran Blvd, Boostan Blvd, Sadra City
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 0000
Fax
+98 71 3643 0038
Email
abualisinacharity@gmail.com
Web page address
http://abualisina.net

2

Recruitment center
Name of recruitment center
Emam Reza (AS) clinic
Full name of responsible person
Mahsa Tahvili
Street address
Namazee Square, Emam Reza (AS) clinic.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpoor
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
memarpour@sums.ac.ir
Web page address
https://rde.sums.ac.ir
Grant name
Grant code / Reference number
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
Mahsa Tahvili
Position
physician /anesthesiology fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
tahvili_m@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saman Asadi
Position
Assistant Professor of Pain Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
asadisa@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Saeedizade
Position
Research Assisstant
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
0098-36281460
Email
saeedi.hamide@gmail.com

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
It is against our policy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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