Evaluation of the effects of hyalase injection into hypertrophic ligamentum flovum on clinical symptoms and MRI findings in lumbar spinal canal stenosis
Evaluation of the effect of Hyalase injection into Hypertrophic Ligamentum Flovum on Clinical Symptoms and MRI findings in Lumbar Spinal Canal Stenosis
Design
Randomized, single-blinded, superiority, parallel-group trial on 40 randomly allocated patients into two equal groups (phase 3 study).
Randomization will be performed via the Research Randomizer website.
Settings and conduct
A single blinded study on 40 patients at department of physical medicine and rehabilitation of Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients with chronic low back pain and claudication due to lumbar canal stenosis secondary to hypertrophy of ligamentum flovum with no response to conservative therapies with no history of laminectomy, coagulopathies and SOL in spinal cord
Intervention groups
Injection of 1 ml of 1500 Unites Hyalase and 40 mg of Methyl Prednisolone into the Ligamentum Flovum on group 1 and Transforminal injection of the same solution on group 2.
Main outcome variables
Chronic Low Back Pain, Neurologic complains, MRI findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110420006239N3
Registration date:2020-11-05, 1399/08/15
Registration timing:registered_while_recruiting
Last update:2020-11-05, 1399/08/15
Update count:0
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
javad yazdani
Name of organization / entity
faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41133559659
Email address
yazdanij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-13, 1399/07/22
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of hyalase injection into hypertrophic ligamentum flovum on clinical symptoms and MRI findings in lumbar spinal canal stenosis
Public title
Therapeutic effects of hyalase injection on lumbar spinal canal stenosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Persistent Low Back Pain
Lumbar Canal Stenosis
Hypertrophy of Ligamentum Flovum
Inefficacy of Conservative therapies
Age over 18
Exclusion criteria:
Laminectomy Surgery
Coagulopathy
Dermal Infection near the site of injection
Presence of SOL in Spinal Cord
Ossification and Calcification
Pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, block randomization will be used to achieve two groups with equal sample size. In order to randomize, first using the site https://www.sealedenvelope.com/simple-randomiser/v1/lists 40 codes (one code for each patient) in the form of two intervention groups with a sample size equal to the use of block sequences will be generated randomly.Each code will then be enclosed in a sealed envelope (40 envelopes in total) containing the study group information and will be kept confidential.At the time of patient admission, an envelope will be randomly assigned to each patient, and only at the time of the procedure will the physician in charge of the procedure have the right to open the envelope and view the procedure prescribed for that particular patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients will be kept unaware of which treatment group they have been assigned to. Furthermore, the data analyst will also be unaware of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciences
Street address
No. 6, West Kahnamuyi Ave, North Shariati St, Valiasr Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5157683165
Approval date
2020-08-11, 1399/05/21
Ethics committee reference number
IR.TBZMED.REC.1399.500
Health conditions studied
1
Description of health condition studied
Lumbar Canal Stenosis secondary to Hypertrophic Ligamentum Flovum
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region
Primary outcomes
1
Description
Pain intensity
Timepoint
Before injection and then one week after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Imaging findings
Timepoint
Before injection and then one week after injection
Method of measurement
MRI findings due to Severity of Lumbar Canal Stenosis
Intervention groups
1
Description
Intervention group: a mixture of Hyalase 1500u and 40mg methylprednisolone injected into the ligamentum flavum
Category
Treatment - Drugs
2
Description
Intervention group: a mixture of Hyalase 1500u and 40mg methylprednisolone injected via transforaminal rout at the level of the stenosis