The Efficacy of Erector Spinae Plane Block for the Relief of Chronic Pain in Cases of Degenerative Disc Diseases.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted on 40 adult patients with degenerative disc disease (DDD) of the lumbar spine and admitted to the Neurosurgery Department at Alexandria Main University Hospital aged between 30 and 65 years old with Visual analog scale more than or equal to 4 not responding to conservative treatment, patients having grade 0, 1 or 2 lumbar disc degeneration without disc bulge or prolapse by X-ray and MRI with loss or decreased lumbar lordosis, patients with black disc and contained disc bulge on magnetic resonance imaging (MRI) and patients with grade I degenerative spondylolisthesis provided that the canal dimensions are normal or with mild stenosis. Patients with severe sciatic pain, patients with more than two levels of DDD of the lumbar region or with isthmic spondylolisthesis and high-grade instability, or patients with disc fragments encroaching upon the exit foramina and nerve root or with severe canal stenosis, also those with central obesity, recurrent disc prolapse or with previous abdominal surgery were excluded from the study. Steroid injection will avoided in patients with immunosuppression or uncontrolled diabetes.
Both a full history taking and a clinical examination will be completed. All patients underwent an MRI of the lumbar region for evaluation. Routine laboratory and other lab investigations will conducted.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alexandria Governorate
-
Alexandria, Alexandria Governorate, Egypt, 21523
- Alexandria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- This study was conducted on 40 adult patients with degenerative disc disease (DDD) of the lumbar spine and admitted to the Neurosurgery Department at Alexandria Main University Hospital aged between 30 and 65 years old with Visual analog scale more than or equal to 4 not responding to conservative treatment, patients having grade 0, 1 or 2 lumbar disc degeneration without disc bulge or prolapse by X-ray and MRI with loss or decreased lumbar lordosis, patients with black disc and contained disc bulge on magnetic resonance imaging (MRI) and patients with grade I degenerative spondylolisthesis provided that the canal dimensions are normal or with mild stenosis
Exclusion Criteria:
- Patients with severe sciatic pain, patients with more than two levels of DDD of the lumbar region or with isthmic spondylolisthesis and high-grade instability, or patients with disc fragments encroaching upon the exit foramina and nerve root or with severe canal stenosis, also those with central obesity, recurrent disc prolapse or with previous abdominal surgery were excluded from the study. Steroid injection was avoided in patients with immunosuppression or uncontrolled diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: injected patients
|
erector spinae plane block
|
|
No Intervention: care provider
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analogue scale
Time Frame: 8 weeks
|
otal scores range from 0 to 10 (based on a scale of 0 to 2 for five items), with a higher score indicating more severe pain.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry disability index
Time Frame: 8 weeks
|
a condition-specific functional measure used to assess the symptoms and severity of low back pain disablement and its impact on patient functional activities
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0305626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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