Trial no.:	PACTR201701001907309	Date of Approval:	05/12/2016
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Lumbar Facet jont block with hyaluronic acid steroid for LBP

Official scientific title

Lumbar facet joint injection with hyaluronic acid versus hyaluronic acid steroid in non radicular low back pain

Brief summary describing the background and objectives of the trial

¿ Chronic spine pain has diagnostic and therapeutic challenges due to multiple pain sources. It may be from vertebral body, inter-vertebral discs, the spinal cord, nerve roots, facet joints, ligaments, muscles, and sacroiliac joint [1]. Facet joint is a common cause for low back pain .Facet pain increases with extension ,prolonged standing, and lateral flexion towards affected side. On the contrary pain decreases with walking, bending forward , sitting and lateral bending towards healthy side. Facet joint injection allow non invasive long term relief of pain may reach to 1 year. It varies from patient to another . Steroids are strong anti-inflammatory that inhibit phospholipase A2 which convert phospholipids to arachidonic acid and thus inhibiting both cyclo_oxygenase and lipo_oxygenase pathways and formation of infilamatory mediators as prostaglandins and thromboxane and leukotrienes Hyaluronic acid is another medication used for treatment of facet joint pain . it has anti-infilammatory action by suppression of IL-1¿ expression [7]. Further suppression of pro-inflammatory mediators IL-8, IL-6, PGE2, and tumor necrosis factor (TNF¿) [8]. It also has analgesic effect by reduction the action of joint nociceptors, which provides pain reduction within the joint [9] . It acts mechanically by its viscous nature which lubricate the joint capsule, preventing degeneration through decreased friction and further protects the joint capsule through beneficial shock absorption effects [10] We hypothesize that a combination of hyaluronic acid steroid injection in patients with low back pain due to facet arthropathy can be more effective than hyaluronic acid solely.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Low back pain,Musculoskeletal Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

15/11/2016

Actual trial start date

15/11/2016

Anticipated date of last follow up

15/12/2016

Actual Last follow-up date

15/12/2016

Anticipated target sample size (number of participants)

50

Actual target sample size (number of participants)

50

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register
MS/15.9.47	IRP /Mansoura faculty of medicicne
	IRP /Mansoura faculty of medicicne
MS/15.9.47	IRP /Mansoura faculty of medicicne

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Group I: Who will receive lumbar facet joint block	lumbar facet joint block with local anesthetic and Hyalgan 1ml(10mg). .	once	patient is placed in a prone position, and the back is cleansed and draped in the usual sterile fashion.The x-ray tube is obliqued to a position parallel to the joint (more obliquity is required in the lumbosacral junction and little obliquity at the thoracolumbar junction). The orientation is selected under fluoroscopy to directly view the joint along the imaging plane, parallel to the articular	25	Active-Treatment of Control Group
Experimental Group	Group II: Who will receive lumbar facet joint block	local anesthetic and Hyalgan 1ml (10mg) plus depomedrol 20 mg in each facet joint .	once	patient is placed in a prone position, and the back is cleansed and draped in the usual sterile fashion.The x-ray tube is obliqued to a position parallel to the joint (more obliquity is required in the lumbosacral junction and little obliquity at the thoracolumbar junction). The orientation is selected under fluoroscopy to directly view the joint along the imaging plane, parallel to the articular	25

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
patients with non low back pain mainly on extension and lateral bending unrelieved by conventional medical treatment as well as physiotherapy.	¿ Patients with radicular pain beyond L3 dermatome . ¿ Previous spine surgery. ¿ LESI in the past 2 months . ¿ Allergy to the drugs used. ¿ Concurrent use of systemic steroid medications. ¿ Opioid addiction. ¿ Pregnancy.		30 Year(s)	70 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

18/09/2016

IRB Mansoura faculty of medicine

Ethics Committee Address
Street address	City	Postal code	Country
Elgmhoria street	Elmansourah	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	effective pain relief (¿60% from baseline)	(VAS) Post procedure pain score 1 hour , 1 day then every month for a duration of 6 months after the procedure .
Primary Outcome	Functional improvement	. Functional improvement by Modified Oswestry Disability Questionnaire (MODQ) at 2 weeks, 1, 2, 4 and 6 months after the procedure.
Secondary Outcome	Incidence of possible complications.	Incidence of possible complications.

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Mansourah university hospital , Mansourah university .	Elgmhoria street	ElMansourah	35516	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Mansoura University hospitals	Elgmhoria street	ElMansourah	35516	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mansoura University hospitals	Elgmhoria street	ElMansourah	35516	Egypt	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country
Mohamed Ehab Abdel Samie El hendawy	Elgmhoria street	ElMansourah	35516	Egypt
Prof. Mohamed Mansour Ali Tawfik	Elgmhoria street	ElMansourah	35516	Egypt
Alaa-Eldin Adel El Maadawy	Elgmhoria street	ElMansourah	35516	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	alaa eldin Elmaadawy	a_maadawy@hotmail.com	00201140065052	Elgomhoria street, Anesthesia department,mansoura university hospitals.
City	Postal code	Country	Position/Affiliation
Elmansoura	35516	Egypt	Lecturer in anesthesia , pain management
Role	Name	Email	Phone	Street address
Public Enquiries	alaa eldin Elmaadawy	a_maadawy@hotmail.com	00201153304999	Elgomhoria street, Anesthesia department,mansoura university hospitals.
City	Postal code	Country	Position/Affiliation
Elmansoura	35516	Egypt	Lecturer in anesthesia , pain management
Role	Name	Email	Phone	Street address
Scientific Enquiries	alaa eldin Elmaadawy	a_maadawy@hotmail.com	00201153304999	Elgomhoria street, Anesthesia department,mansoura university hospitals.
City	Postal code	Country	Position/Affiliation
Elmansoura	35516	Egypt	Lecturer in anesthesia , pain management

REPORTING
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Changes to trial information

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