Comparison of the therapeutic effect of Ultrasound-Guided Injection of Botulinum Toxin Type A with Methylprednisolone in Piriformis Muscle Syndrome
Design
The study is a single-blinded (analyzers & assessor) clinical trial and the sampling will be done through a simple randomization method
Settings and conduct
Patients will be randomly divided into two groups. The research was carried out in physical medicine and rehabilitation clinic at Firoozgar hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients age : 20 years or older; Screening of patients for clinically significant Lumbar disk herniation or Lumbosacral radiculopathy by Magnetic Resonance Imaging; Trigger point and tenderness in their Gluteal area; Pain in their buttocks radiating toward their thigh or lower limb and increasing with prolonged sitting and walking and during bending; Increased pain through passive forced hip flexion, adduction, and internal rotation (FAIR position), and pain when the leg was flexed at the knee and the hip was passively and medially rotated (Freiberg test).
Non- Inclusion criteria: Known allergy or sensitivity to botulinum toxin type A; Previous use of botulinum toxin type A or B; Current or planned pregnancy; Disorders affecting the Neuromuscular junction or Motor neuron disease,Neurologic deficits found during Electromyelography.
Intervention groups
Intervention group : US-Guided Injection of 150 U of botulinum toxin type A (Dysport 50-U/ml solution) in 3 ml of normal saline. Control group: US-Guided injection of 1 cc methylprednisolone &1 cc lidocaine 1%
Main outcome variables
Pain; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191213045717N1
Registration date:2020-02-19, 1398/11/30
Registration timing:prospective
Last update:2020-02-19, 1398/11/30
Update count:0
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
Zeynab Shahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7749 6616
Email address
zeynab.shahabi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Trial of Botulinum Toxin Type A and Methylprednisolone for The Treatment of Piriformis Syndrome
Public title
Effect of Botulinum Toxin Type A and Methylprednisolone in treatment of Piriformis Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients age : 20 years or older
Screening of patients for clinically significant Lumbar disk herniation or Lumbosacral radiculopathy by Magnetic Resonance Imaging
Trigger point and tenderness in their Gluteal area
Pain in their buttocks radiating toward their thigh or lower limb and increasing with prolonged sitting and walking and during bending
Increased pain through passive forced hip flexion, adduction, and internal rotation (FAIR position), and pain when the leg was flexed at the knee and the hip was passively and medially rotated (Freiberg test)
Having pain for more than 3 months despite the conservative treatment and those whose individual minimum pain severity scores will be greater than 5 on a 10-point numeric rating scale (VAS criteria)
Exclusion criteria:
Known allergy or sensitivity to botulinum toxin type A
Previous use of botulinum toxin type A or B
Current or planned pregnancy
Disorders affecting the Neuromuscular junction or Motor neuron disease,Neurologic deficits found during Electromyelography
Administration of Amino- Glycosides or other drugs that interfere with Neuromuscular transmission
Previous Micro- surgery or Macro-surgery for disc disease, and any Epidural block within 7 weeks of enrollment
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
At the begining of the study, all patients in the two groups will be injected in the same place of the body. Post-injection care is the same in all groups. It is worth noting that patients in any of the two groups are not aware of the content of the injections.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Universiy of Medical Science
Street address
Medical School, Iran University of Medical Sciences, Hemmat High way
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-12-03, 1398/09/12
Ethics committee reference number
IR.IUMS.FMD.REC.1398.387
Health conditions studied
1
Description of health condition studied
piriformis muscle syndrome
ICD-10 code
S74.0
ICD-10 code description
Injury of sciatic nerve at hip and thigh level
Primary outcomes
1
Description
The severity of Pain
Timepoint
Before treatment, 1th ,4th,8th &12th weeks after the end of treatment
Method of measurement
Visual Analog Scale (VAS)
2
Description
Quality of life
Timepoint
Before treatment,4th week after the end of treatment
Method of measurement
36-Item Short Form Health Survey (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 150 U of botulinum toxin type A (Dysport 50-U/ml solution from Daryan Salamat Pharma Group) in 3 ml of normal saline using 22 gauge LP(Lumbar Puncture) needle under ultrasound guidance (lateral approach) will be injected in piriformis muscle.
Category
Treatment - Other
2
Description
Control group: 1 cc methylprednisolone (Exir Pharmaceutical Company, made in Iran) &1 cc lidocaine 1% (Aburaihan Pharmaceutical Company, made in Iran) using 22 gauge LP needle under ultrasound guidance (lateral approach) will be injected in piriformis muscle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Educational Hospital
Full name of responsible person
Dr Tannaz Ahadi
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin street, Karim Khane Zand street, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
H_Firoozgar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abas Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@yahoo.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
Zeynab Shahabi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin street, Karim Khane Zand street, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
zeynab.shahabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Tannaz Ahadi
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin street, Karim Khane Zand street, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
tannaz.ahadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeynab Shahabi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin street, Karim Khane Zand street, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1229
Email
zeynab.shahabi@gmail.com
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