The Evaluation of Effects of Intra-articular Botulinum Neurotoxin in Knee Osteoarthritis
Design
An intervention without a control group
Settings and conduct
For each knee, injection of 250 units of botulinum toxin (Dysport) in 501 hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age > 50
2. Crepitation or morning stiffness < 30 min
3. Radiographic presentation
4. Clinical symptom >3 months
Exclusion criteria:
1. Patient dissatisfaction
2.Other articular disease in knee joint( RA, Gout, MG, LEMS, ALS)
3.surgical or fracture history in the joint
4. Corticosteroid knee injection in the last 2 weeks, hyalorunic acid injection or prolotherapy over the past year
5.Any intraarticular injection contraindication
Intervention groups
For each knee, we injected 250 units of botulinum toxin (Dysposort) diluted with 5 cc normal saline.Patients will be evaluated based on KOOS, VAS questionnaires. Variables are evaluated before treatment and one month after the end of treatment.
Main outcome variables
Pain; symptoms( stiffness, range of motion); activity of daily living( sitting and standing, upstairs, walking); quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039323N1
Registration date:2018-07-29, 1397/05/07
Registration timing:retrospective
Last update:2018-07-29, 1397/05/07
Update count:0
Registration date
2018-07-29, 1397/05/07
Registrant information
Name
Zahra Rezasoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
z.rezasoltani@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-30, 1397/02/10
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of Effects of Intra-articular Botulinum Neurotoxin on Pain and Function in Patients with Knee Osteoarthritis
Public title
Intra-articular Botulinum Neurotoxin in Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age ⩾50
crepitation or morning stiffness < 30 min
radiographic presentation
clinical symptom > 3 months
Exclusion criteria:
Patient dissatisfaction
Other articular disease in knee joint
Surgical history in the joint
Fracture history in bones of knee
Corticosteroid knee injection in the last 2 weeks, hyalorunic acid injection or prolotherapy over the past year
Any intraarticular injection contraindication
Allergy to toxin
Severe knee joint effusion
Age
From 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Artesh University of Medical sciences