An Investigation into the Efficacy of Intra-articular Injection of Botulinium Toxin versus Steroid on Pain and Function of Patients with Knee Osteoarthritis
Objectives:The aim of this study is to compare efficacy and safety of intra articular injection of Botulinium toxin versus steroid (triamcinolon acetonide) in patients with knee OA. Study Design: Double blind Randomized controlled clinical trial. Setting and Conduct: In this study a total of 40 patients with more than three months of chronic pain in the knee joints along with consistent imaging findings (Kellgren-Lawrence score of Ⅱ&Ⅲ) would be enrolled and randomly allocated into two groups of Botulinium toxin and steroid. Participants: Patients suffering from mild to moderate knee OA refered to Shahid Modarres Hospital of Saadat Abad in Tehran in 2016. Interventions: a single injection of Botulinium toxin, Dysport® (half of a 500-IU vial) in one group and a single vial of 40 mg/ml triamcinolone acetonide in other group. Outcome measuers: Patients would be evaluated at baseline and 8 & 24 weeks after injection for pain, stiffness and function using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103013442N20
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Investigation into the Efficacy of Intra-articular Injection of Botulinium Toxin versus Steroid on Pain and Function of Patients with Knee Osteoarthritis
Public title
An Investigation into the Efficacy of Intra-articular Injection of Botulinium Toxin versus Steroid on Pain and Function of Patients with Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critetia: Confirmed knee-osteoarthritis patients based on American College of Rheumatology (ACR) criteria with ages ranging from 40 to 75 years; more than 3 months symptoms resistant despite the conservative treatment; grade 2 or 3 according to KLS system in plain x-ray film.
Exclusion criteria: Infection and active wound in knee; Gout or psudogout; neuromuscular illnesses; Pregnancy or breast-feeding; any history of intra articular injection over the past 3 months; Acute trauma of knee; Recent physiotherapy during last 3 months; Genuvarum or valgum more than 20 degrees; Radioculophathy; BMI≥35; Hx of allergy to Botulinium Toxin; Systemic illnesses like diabetes melitus, immunodeficiency, and vascular collagen diseaes; prior history of cancer or active malignant lesions; ages below 40 years or above 75 years.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Sahahid Arabi street, Yaman street, Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.SBMU.MSP.REC.1396.113
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Knee Pain
Timepoint
Before intervention and 8 & 24 weeks after injection
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Pain
Timepoint
Before intervention and 8 & 24 weeks after injection
Method of measurement
VAS questionnaire
2
Description
Joint Stiffness
Timepoint
Before intervention and 8 & 24 weeks after injection
Method of measurement
WOMAC questionnaire
3
Description
Patient Function
Timepoint
Before intervention and 8 & 24 weeks after injection
Method of measurement
WOMAC questionnaire
Intervention groups
1
Description
Intervention group 1: Botulinium toxin, knee intraarticuar injection, half of 500-IU vial, a single injection
Category
Treatment - Drugs
2
Description
Intervention group 2: Triamcinolone acetonide, knee intraarticuar injection, 1cc of 40mg/ml vial, a single injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Ehsan Enayati
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Seyed Ahmad Raeissadat
Street address
Physical Medicine and Rehabilitation Department, Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Physical Medicine and Rehabilitation Department, Shahid Beheshti University of Medical Sciences, Sch
Full name of responsible person
Ehsan Enayati
Position
Resident in PM&R
Other areas of specialty/work
Street address
Shahid Modarres hospital, Kaj square, Saadat abad street
City
Tehran
Postal code
Phone
+98 21 2273 1112
Fax
Email
dr.enayati1984@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street
City
Tehran
Postal code
q
Phone
+98 21 2273 1112
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor
Other areas of specialty/work
Street address
Modares Hospital, Kaj Square, Saadat Abad Street
City
Tehran
Postal code
Phone
+98 21 2273 1112
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)