Protocol summary
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Study aim
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A comparison between effectiveness of gluteal trigger points injection with epidural steroid injection in lumbosacral canal stenosis patients
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Design
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the research is a randomize double blind clinical trial
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Settings and conduct
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The patients who had lumbosacral canal stenosis were selected from Emam Reza clinic and Rajaee hospital, then patients were divided into two groups and after obtaining written consent the study was begun. In the control group, steroid was injected into epidural, and in the intervention group, steroid was injected in the gluteal trigger points. Then its effects on reducing patients' pain and improving function were measured.
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Participants/Inclusion and exclusion criteria
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Exclusion criterria:
Infection involving lumbar spinal (brucella),
Diabetes mellitus,
Rhumatological disorder(lupuse, gout),
BMI more than 42 ,
Pregnancy,
Malignancy,
Liver disease,
History of allergies,
Malnutrition,
Peripheral neuropathy,
Bleeding disorder,
Galactosemia,
Radiculopathy.
Inclusion criteria:
Age: 40-75 years old,
Being diagnosis with lumbar canal stenosis accordining to MRI or EDX,
Complaining low back pain , psudoclaudication ,parestesia that no responsed to conservative treatment ,
Sex:male or female
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Intervention groups
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Group1: received an injection of steroid into gluteal trigger points.
Group 2: received steroid epidural injection under fluoroscopic guide.
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Main outcome variables
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pain, activity of daily living
General information
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Reason for update
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1-Date transfer: Due to the delay in the acceptance and approval process and we expected a shorter time, we started the sick time earlier.
2. Being blind on both sides due to a typographical error
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190802044411N1
Registration date:
2020-11-26, 1399/09/06
Registration timing:
prospective
Last update:
2021-05-20, 1400/02/30
Update count:
1
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Registration date
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2020-11-26, 1399/09/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-22, 1399/06/01
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Expected recruitment end date
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2022-03-10, 1400/12/19
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Actual recruitment start date
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2020-11-27, 1399/09/07
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Actual recruitment end date
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2021-03-18, 1399/12/28
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Trial completion date
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2021-05-14, 1400/02/24
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Scientific title
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A comparison between effectiveness of gluteal trigger injection with epidural steroid injection in lumbosacral canal stenosis patients
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Public title
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Gluteal trigger point injection in lumbosacral canal stenosis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age : 40 to75 years old
Being diagnosis with lumbar canal stenosis according to mri or edx
Complaining low back pain , psudoclaudication , parestesia that no responsed to conservative treatment
Gender: male or female
Exclusion criteria:
Infection involving lumbar spinal (brucella)
Diabetes mellitus
Rhumatological disorder(lupuse, gout)
BMI more than 42
Pregnancy
Malignancy
Liver disease
sensitivity reaction to test drug
Malnutrition
Peripheral neuropathy
Bleeding disorder
Galactosemia
Radiculopathy
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Age
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From 40 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Complete randomized block design with random allocation software was used for randomization and the list of patients was prepared by a computer with the same block length and the secretary divided the patients based on the list of patients.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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clinical caregiver: we taught the caregiver how to complete the questionnaire. this person was not aware of the allocation to groups.
The outcome assessor who completed the questionnaires was not aware of the group allocation.
Data analyzer: Questionnaires were finally given to a person to review the information. This person does not know any of the steps of the work, how groups were classified and the intervention performed.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-22, 1398/04/01
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.221
Health conditions studied
1
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Description of health condition studied
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lumbosacral canal stenosis
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ICD-10 code
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M99.53
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ICD-10 code description
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Intervertebral disc stenosis of neural canal of lumbar region
Primary outcomes
1
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Description
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radicular low back pain
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Timepoint
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two weeks, four weeks, eight weeks
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Method of measurement
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Visual Analogue Scale
Secondary outcomes
1
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Description
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function of patient
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Timepoint
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two weeks, four weeks , eight weeks
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Method of measurement
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The Quebec Back Pain Disability Scale
Intervention groups
1
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Description
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Intervention group: The group that received 80 mg Amp Methylprednisolon and 4 cc Amp Marcaine epidural injection with fluoroscopic guidance and then two weeks , four weeks, eight weeks after first dose injection , VAS, Oswestry, Quebec , RMQ was filled.
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Category
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Rehabilitation
2
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Description
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Control group: The group that received injection of 80 mg Methylprednisolon amp and 5 cc of lidocaine amp in gluteal trigger points, then two weeks, four weeks and eight weeks after first dose, VAS, Oswestry, Quebec, RMQ questionnaires were filled.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shiraz University of medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All available data can be shared after making people unidentifiable
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When the data will become available and for how long
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start access period one year after publishing the results
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To whom data/document is available
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everyone can access to this information
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Under which criteria data/document could be used
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if the information in this study helps to improve the science process
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From where data/document is obtainable
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khoshnazar31@yahoo.com
00989131434549
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What processes are involved for a request to access data/document
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after sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.
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Comments
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