Objectives: This study is aimed to evaluate ultrasound-Guided Medial-Branch Block for Lumbar facet joints in patients with chronic low back pain in the facet joint region who were referred to pain clinics of Akhtar Hospitals between 2012-2013 years.
Design: Prospective clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: patients with chronic low back pain in the facet joint region who were referred to pain clinics of Akhtar Hospitals between 2012-2013 years, were included.
Intervention: Local anesthesia was provided by injection of 1% lidocaine 1 mL. A 21-gauge, 9-cm spinal needle was directed in the ultrasound plane at an angle of approximately 45 to 60 degrees to the skin and was advanced laterally and medially until the needle tip reached the target and bony contact was felt. A longitudinal paravertebral ultrasound view was then obtained to verify the position of the needle at the cephalad margin of the transverse process. C-arm fluoroscopy was performed to assess the precision of the needle location. Needle position was evaluated according to the International Spinal Society guidelines and considered to be in target, if it was slightly medial to the lateral margin of silhouette of the superior articular process (SAP) in the posteroanterior view and high on the eye of the Scotty dog in the oblique view. If the needle was out of the radiologic target or invisible in the sonography, it was repositioned under fluoroscopy guidance before the drug was injected.
Then, For all patients were injected mix of triamcinolone acetonide 40 mg and 1% lidocaine 1 mL at L1-L2, L2-L3, L3-L4, L4-L5, L5-S1 levels on the right/left side for treatment of lumbar facet joint pain.
Main outcome measures (variables): Visual analog scale; Oswestry disability index score; Success rate; Time of needle placement; Patient request for analgesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306168435N6
Registration date:2013-07-09, 1392/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-09, 1392/04/18
Registrant information
Name
Seyed Masoud Hashemi
Name of organization / entity
Department of Anesthesiology and Pain
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
mohammadinasab@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasound-Guided Medial-Branch Block for pain management of Lumbar facet joints pain in patients referral to Akhtar hospital between 2012-2013 years.
Public title
Management of chronic lumbar pain with ultrasound-guided for block of lumbar facet joints
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: Age > 18 years old; Symptoms of chronic low back pain for more than three months; Persistent low back pain with or without pain radiating to the upper leg; Focal tenderness over the lumbar spine joint; Hyperextension pain; Absence of neurological defects; Contraindication of lumbar surgery; Absence of radicular syndrome; No respond to traditional treatments; Signing consent to participate in the study.
Main exclusion criteria: Lumbar radicular pain; Disc with radicular symptoms of pain associated with radiological or neurological tests; Coagulation disorders; Allergy to local anesthetic solution; Malignancy; Psychiatric problems and poor patient cooperation; Speech problems; Pregnancy; Surgery indication; Local skin infection at the operative site; Spinal deformities; Body mass index > 29 kh/m2
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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 and Health Services
Street address
Tabnak S.
City
Tehran
Postal code
Approval date
2012-01-13, 1390/10/23
Ethics committee reference number
P/1390-10-23
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Diagnosis Low back pain
Primary outcomes
1
Description
Time of needle placement
Timepoint
During procedure
Method of measurement
The time from insertion into skin until fluoroscopic confirmation
2
Description
Patient request for analgesia
Timepoint
Before, immediately after, and one week, 4 and 6 weeks after the procedure
Method of measurement
Based on the patient's request
3
Description
Disability measurement
Timepoint
Before, immediately after, and one week, 4 and 6 weeks after the procedure
Method of measurement
Oswestry disability index score
4
Description
Success rate
Timepoint
Immediately after the procedure
Method of measurement
Pain relief more than 50%
5
Description
Pain score
Timepoint
Before, immediately after, and one week, 4 and 6 weeks after the procedure
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ultrasound guided nerve block
Category
Treatment - Other
2
Description
Control group: Conventional fluoroscopy guided nerve block
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Seyed Masoud Hashemi MD
Street address
Elahiye St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences and Health Services