Comparsion between Therapeutic Effects of Intra-articular Botulinum Neurotoxin , Hyaluronic Acid, Prolotherapy with Dextrose and Physical Therapy in Knee Osteoarthritis
Comparison between Therapeutic Effects of Intra-articular Botulinum Neurotoxin , Hyaluronic Acid, Prolotherapy with Dextrose and physical therapy in Knee Osteoarthritis
Design
Clinical trial with control group,parallel group trial with single blinded outcome assessment, Randomised
Settings and conduct
The clinical trial is done at Tehran-Imam Reza Hospital,120 patients with Knee Osteoarthritis are randomly divided into groups of intervention (intra-articular injection of Botulinum Neurotoxin, Hyaluronic Acid, Prolotherapy with Dextrose at Knee) and control (physical therapy).Outcome assessments based on the Visual Analogue Scale are performed before the intervention, one month and three months later.The study is single blind and result's evaluator is kept blind.
Participants/Inclusion and exclusion criteria
Including criteria: Patients with knee osteoarthritis based on American College of Rheumatology criteria; Exclusion criteria: People with any rheumatologic, internal or neuromuscular disease that affects the knee joint,Patients with history of intra-articular injection or knee surgery or Patients who have contraindications for intra-articular injection.
Intervention groups
Intervention groups: Intra-articular injection of Botulinum Neurotoxin, Hyaluronic Acid, Prolotherapy with Dextrose at Knee
Control group: Physical therapy for Knee Osteoarthritis
Main outcome variables
Pain Severity based on Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181217042028N2
Registration date:2019-04-18, 1398/01/29
Registration timing:retrospective
Last update:2019-04-18, 1398/01/29
Update count:0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Fatemeh Abdorrazaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 1827
Email address
rezasoltani@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion between Therapeutic Effects of Intra-articular Botulinum Neurotoxin , Hyaluronic Acid, Prolotherapy with Dextrose and Physical Therapy in Knee Osteoarthritis
Public title
The Comparsion between Therapeutic Effects of Intra-articular Botulinum Neurotoxin , Hyaluronic Acid, Prolotherapy with Dextrose and Physical Therapy in Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 50
Crepitus or morning stiffness for less than 30 minutes
Radiographic finding
Symptoms longer than 3 monthes
Exclusion criteria:
Patient dissatisfaction
The presence of other knee joint diseases
History of surgery in the desired joint
History of fracture in knee bones
Intra-articular corticosteroid injection in the last 2 weeks
Contraindication of intera-articular injection
Immunodeficeincy
Sensitivity to botulinum toxin
Dysfunction of the lower extremity due to neurological or internal medicine
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with Knee Osteoarthritis will be recruited from the waiting list of an outpatient Department of Physical Medicine and Rehabilitation at Imam Reza Hospital. The Hospital is a large referral subspecialty center in Tehran affiliated with Artesh University of Medical Sciences. We are going to use block randomization with variable block size to provide four samples of equal size. Random numbers will be generated with a computer in an independent statistical office.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant will be informed of his treatment, benefits and disadvantages,then consciously and satisfied be entered the study. The researcher also knows the type of treatment.The person who evaluates the outcome and the analyzer do not have any information on the type of treatment and are kept Blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Artesh University of Medical sciences
Street address
Artesh medical university, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.AJAUMS.REC.1397.012
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Unilateral primary osteoarthritis of knee
Primary outcomes
1
Description
Pain Severity based on Visual Analogue Scale
Timepoint
Before intervention, one and three months later
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Intra-articular injection of Botulinum Toxin at the knee
Category
Treatment - Drugs
2
Description
Second Intervention group: Intra-articular injection of Hyaluronic Acid at the knee
Category
Treatment - Drugs
3
Description
Third Intervention group: Intra-articular Prolotherapy with Dextrose at the knee
Category
Treatment - Drugs
4
Description
Control group: Physical Therapy for Knee Osteoarthritis
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Zahra Rezasoltani
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezai
Street address
Artesh medical university, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Fatemeh Abdorrazaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam reza hospital, Etemadzade St, West Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 6652 1827
Fax
Email
z.rezasoltani@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fatemeh Abdorrazaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fatemeh Abdorrazaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Etemad zade Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.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