Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
Design
Two arm parallel group clinical trial with single blinded block randomization.
Settings and conduct
This study is single blind randomized clinical trial about chronic low back pain that is done in Firuzgar hospital.
Participants/Inclusion and exclusion criteria
Entrance criteria:
Age above the 18 years old; Axial Non Radicular Low Back Pain that conservative treatment more than 3 Month is failed; Para Spinal Pain with Local Tenderness of Facet Joint that exacerbated with Extension and Lateral Rotation; MRI is Normal.
Exit criteria:
Obese Patient; Neurological Disorder; Tumor, General Infection or Skin Infection of Injection Site; Coagulopathy; Sensitivity to Lidocaine and Steroid; Previous Surgery of Back; Pregnancy;'v Non-Cooperative Patient
Intervention groups
First randomized group goes under Medial Branch Block in 2 Levels (same and above level ) under Ultra sound-Guided with 2miligram(mg) Lidocaine and 1mg Triamcinolone and second randomized group goes under Facet joint injection in 2 Levels (same and above level ) under Ultra sound-Guided with 2miligram(mg) Lidocaine and 1mg Triamcinolone.
Main outcome variables
The effect of low back pain in ability of daily living, severity of sign
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038889N1
Registration date:2018-07-31, 1397/05/09
Registration timing:registered_while_recruiting
Last update:2018-07-31, 1397/05/09
Update count:1
Registration date
2018-07-31, 1397/05/09
Registrant information
Name
Amirhossein Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8846 8248
Email address
sa.amirhossein@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
Public title
Comparison of the Effectiveness of Medial Branch Block with Facet Joint Injection under Ultrasonography-Guide in patient with chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above the 18 years old.
Axial Non Radicular Low Back Pain that Conservative Treatment more than 3 Month is failed .
Para Spinal Pain with Local Tenderness of Facet Joint that exacerbated with Extension and Lateral Rotation.
MRI is Normal.
Exclusion criteria:
Obese Patient
Neurological Disorder
Tumor
General Infection or Skin Infection of Injection Site
Coagulopathy
Sensitivity to Lidocaine and Steroid
Previous Surgery of Back
Pregnancy
Non-Cooperative Patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated in Tow Groups with Block Randomization. If first Patient have more than One Year Pain, he or she will enter in Medial Branch Block and if have less than One Year Pain, he or she will enter in Facet Joint Block. Second Patient if have more than One Year Pain, he or she will now enter in Facet Joint Group and if have less than One Year Pain, he or she will enter in Medial Branch Block. The others are allocated as the same way.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient do not know in witch Randomized Group(Facet Joint Group or Medial Branch Block) are entered.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran university of medical science
Street address
Shahid Hemat Highway,Ethics committee of iran university of medical science,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.IUMS.FMD.REC
Health conditions studied
1
Description of health condition studied
Lumbar facetogenic pain syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of low back pain on Ability of Daily Living
Timepoint
Zero, Four weeks
Method of measurement
Oswestry Disability Index questioner
2
Description
Severity of sign
Timepoint
Zero, One week , Four weeks
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lumbar facet joint injection with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert
Category
Treatment - Other
2
Description
Intervention group: Lumbar Medial branch block with mixture of Lidocaine and Corticosteroid under Ultra sound Guide by Physical Medicine and Rehabilitation Expert