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Evaluation the effects of clacitonin transforaminal epidural injection with caudal epidural injection in patients with degenerative spinal canalstenosis; a double-blinded randomized clinical trial

Protocol summary

Study aim
Evaluation the effects of clacitonin transforaminal epidural injection with caudal epidural injection in patients with degenerative spinal canalstenosis
Design
Clinical trial with control group, with parallel groups, double blinded, randomized, phase 3
Settings and conduct
This double-blinded phase 3 clinical trial will be conducted on 40 patients in two groups (20 patients in the calcitonin epidural caudal group and 20 patients in the transforaminal epidural calcitonin group) by randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic low back pain with a history of more than six months with or without dissemination to the lower extremity, Moderate to high pain (pain score over 3), Age between 40 to 70 years, Lack of proper response to drug treatments and conservative for three months, Absence of protruding disc, Severe channel tightness, Lack of reduction in vertebral height be more than 60%. Exclusion criteria: Severe spinal deformity, Spinal tumors, Spinal fracture, Local or systemic infection, Anticoagulant drug use, History of severe mental illness, Pregnancy and lactation, Patient dissatisfaction
Intervention groups
First intervention group: In the calcitonin epidural caudal group, calcitonin will be injected with a dose of 50 IU (Caspiantamin Company). Second intervention group: In the clacitonin transforaminal epidural group, calcitonin will be injected with a dose of 50 IU (Caspiantamin Company).
Main outcome variables
Pain, Inability to stand due to pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120814010599N29
Registration date: 2021-04-21, 1400/02/01
Registration timing: prospective

Last update: 2021-04-21, 1400/02/01
Update count: 0
Registration date
2021-04-21, 1400/02/01
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of clacitonin transforaminal epidural injection with caudal epidural injection in patients with degenerative spinal canalstenosis; a double-blinded randomized clinical trial
Public title
Comparing the clacitonin transforaminal epidural injection with caudal epidural injection in degenerative spinal canalstenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic low back pain with a history of more than six months with or without dissemination to the lower extremity Moderate to high pain (pain score over 3) Age between 40 to 70 years Lack of proper response to drug treatments and conservative for three months Absence of protruding disc Severe channel tightness Lack of reduction in vertebral height be more than 60%
Exclusion criteria:
Severe spinal deformity Spinal tumors Spinal fracture Local or systemic infection Anticoagulant drug use History of severe mental illness Pregnancy and lactation Patient dissatisfaction
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients, using random allocation software, were randomly divided into clacitonin transforaminal epidural injection with caudal epidural injection. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and the statistical analyzer were unaware that the patient was exposed to the clacitonin transforaminal epidural injection with caudal epidural injection. The groups are provided to the statistical analyzer in the form of codes A and B for analysis.
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 Sciences.
Street address
Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat exp way
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2021-04-18, 1400/01/29
Ethics committee reference number
IR.IUMS.REC.1400.092

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified

Primary outcomes

1

Description
Pain
Timepoint
Four times including two weeks later, 1 month, 3 months and 6 months after surgery
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Inability to stand due to pain
Timepoint
Four times including two weeks later, 1 month, 3 months and 6 months after surgery
Method of measurement
Oswestry Low Back Pain Disability questionnaire

Intervention groups

1

Description
Intervention group 1: In the calcitonin epidural caudal group, calcitonin will be injected with a dose of 50 IU (Caspiantamin company).
Category
Treatment - Drugs

2

Description
Intervention group 2: In the clacitonin transforaminal epidural group, calcitonin will be injected with a dose of 50 IU (Caspiantamin company).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Poupak Rahim Zadeh
Street address
Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh “St.”,Sattarkahn “Ave.”, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Email
poupak_rah@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abas Motavalian
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Email
poupak_rah@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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