Cervical Epidural Steroid Injection: Parasagittal approach as an alternative to the midline approach in patients with unilateral cervical radicular pain; a comparative randomized clinical trial
Comparing the efficacy of parasagittal and midline techniques of cervical epidural injection in patients with unilateral cervical radicular pain with regard to alleviation of pain and cervical functional disability.
Design
Single-blind randomized comparative clinical trial with two parallel groups with a total of 26 patients
Settings and conduct
Patients with unilateral cervical radicular pain unresponsive to noninvasive treatments who referred to Akhtar hospital, Imam hossein hospital and Shahid Labbafinejad Clinic, underwent cervical epidural injections either with a parasagittal or midline approach. Both patients and physicians who were in charge of data recording were blind to the groups to which the patients were allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age between 18 and 65 years
2. Unilateral cervical radicular pain in an upper extremity
3. Pain duration of at least 3 months
4. Pain unresponsive to conservative treatments such as pharmaceutical treatments and physical therapy for 6 weeks
Exclusion criteria:
1. Pregnancy
2. Breast feeding
3. Allergy to a study medication
4. Signs/symptoms of cervical myelopathy
5. Signs/symptoms of progressive unstable nerve damage
6. Cervical spinal stenosis
7. Proven psychiatric disorder
8. Coagulopathy
9. Infection at injection site
10. Uncontrolled medical illness eg, hypertension and diabetes
Intervention groups
Patients who received cervical epidural injections with steroid and local anesthetic through either a parasagittal or midline approach.
Main outcome variables
Pain intensity measurement with Numeric Rating Scale (NRS); Evaluation of neck disability with Neck Disability Index (NDI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180524039816N1
Registration date:2018-09-24, 1397/07/02
Registration timing:retrospective
Last update:2018-09-24, 1397/07/02
Update count:0
Registration date
2018-09-24, 1397/07/02
Registrant information
Name
Kasra Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
zakerihabib@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-17, 1397/02/27
Expected recruitment end date
2018-06-01, 1397/03/11
Actual recruitment start date
2018-05-17, 1397/02/27
Actual recruitment end date
2018-06-01, 1397/03/11
Trial completion date
empty
Scientific title
Cervical Epidural Steroid Injection: Parasagittal approach as an alternative to the midline approach in patients with unilateral cervical radicular pain; a comparative randomized clinical trial
Public title
Comparison of parasagittal and midline interlaminar epidural steroid injections in unilateral cervical radicular pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral upper extremity radicular pain due to a cervical disc pathology
Pain duration of at least 3 months
Pain unresponsive to conservative treatment such as medical and physical therapy for 6 weeks
Patients' age between 18 and 65 years
Exclusion criteria:
Pregnancy
Breast feeding
Allergy to one of medications used in the study
Signs and symptoms of cervical myelopathy
Sings and symptoms indicating a progressive, unstable nerve damage
Cervical spinal canal stenosis
Proven psychiatric disorder
Coagulopathy
Infection at the site of injection
Presence of an uncontrolled medical problem eg, high blood pressure, diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Patients received cervical epidural injections either with a parasagittal or a midline approach. Computerized random allocation of patients into one the two groups was done using a random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since patients could not see the needle entry point and needle entry points in the two methods used in this study were very close (no more than a few millimeters apart), patients were blind about the group to which they were allocated. Physicians conducting the procedures knew the type of procedure (parasagittal vs midline) they were about to perform on patients and were not blinded to the procedure. Physicians who recorded the pre- and post-intervention data were not aware of the groups to which the patients were allocated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Pain severity measured by NRS (Numeric Rating Scale)
Timepoint
Before and one month after the intervention
Method of measurement
Pain severity according to NRS (Numeric Rating Scale)(Zero to 10; 0 indicating no pain and 10 indicating the worst conceivable pain)
2
Description
Degree of neck disability measured by NDI (Neck Disability Index)
Timepoint
Before and one month after the intervention
Method of measurement
Degree of neck disability measured with NDI (Neck Disability Index) (expressed as percent)
Secondary outcomes
1
Description
Evaluation of radiocontrast spread pattern in parasagittal and midline cervical epidural injections
Timepoint
At the time of the procedure
Method of measurement
Pattern of radiocontrast spread describe as (1) predominantly midline, (2) predominantly ipsilateral to the painful side, (3) predominantly contralateral to the painful side
Intervention groups
1
Description
Control group: Cervical epidural steroid and local anesthetic injection with the midline approach
Category
Treatment - Other
2
Description
Intervention group: Cervical epidural steroid and local anesthetic injection with the parasagittal approach