Protocol summary
-
Study aim
-
The purpose of this study is to compare the effect of Dextrose prolotherapy on the severity of knee pain in acupuncture points and non-acupuncture points in patients with knee osteoarthritis.
-
Design
-
Twenty-six patients with bilateral knee osteoarthritis were selected based on inclusion criteria. Different intervention will be performed on each knee. This study is double blinded, patients and those who study the outcomes of the study are unaware of the grouping and type of intervention.
-
Settings and conduct
-
The site of this study is a special clinic of Kurdistan University of Medical Sciences.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria include: patients with knee osteoarthritis, Over 50 years of age, Less than 30 minutes of morning stiffness, Crepitus on active motion, Bony tenderness, Bony enlargement and no palpable warmth of synovium. Exclusion criteria include:Injection of steroid drugs in the last 2 months, Diabetes, Candidate for knee surgery, Previous treatment with dextrose injection, Knee Infections in the last three months, Knee inflammation, Daily opioid Use, History of arthritis, Arthritis after infection, Joint dysplasia, Congenital anomaly, Crystalopathy, Arthritis after injury, Malignancy, Vascular necrosis and bmi more than 30.
-
Intervention groups
-
In the first intervention group, 8 ml of dextrose 20% and 2 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points and in the second intervention group, 8 ml of dextrose 20% and 2 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
-
Main outcome variables
-
Knee pain severity;morning Stiffness; physical activity
General information
-
Reason for update
-
Update trial steps
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20181114041657N1
Registration date:
2018-12-08, 1397/09/17
Registration timing:
prospective
Last update:
2020-03-13, 1398/12/23
Update count:
5
-
Registration date
-
2018-12-08, 1397/09/17
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-04-04, 1398/01/15
-
Expected recruitment end date
-
2019-07-06, 1398/04/15
-
Actual recruitment start date
-
2019-04-04, 1398/01/15
-
Actual recruitment end date
-
2019-07-09, 1398/04/18
-
Trial completion date
-
2019-10-02, 1398/07/10
-
Scientific title
-
Dextrose prolotherapy effects on the Pain of Knee Osteoarthritis: Comparison of Injection in Acupuncture Points versus Non-Acupuncture points
-
Public title
-
The effect of injection of dextrose solution on the severity of knee pain
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with knee osteoarthritis
Over 50 years of age
Less than 30 minutes of morning stiffness
Crepitus on active motion
Bony tenderness
Bony enlargement
No palpable warmth of synovium
Exclusion criteria:
Injection of steroid drugs in the last 2 months
Diabetes
Candidate for knee surgery
Previous treatment with dextrose injection
Knee Infections in the last three months
Knee inflammation
Daily opioid Use
History of arthritis
Arthritis after infection
Joint dysplasia
Congenital anomaly
Crystalopathy
Arthritis after injury
Malignancy
Vascular necrosis
bmi>30
-
Age
-
From 50 years old to 80 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
26
More than 1 sample in each individual
Number of samples in each individual:
26
Patients are enrolled in the study, with both knees suffering from osteoarthritis. Different interventions are performed on each knee.
Actual sample size reached:
26
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients were selected using randomized blocking method and entered the study.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Patients and collaborators who evaluate the outcomes of the study are blind to the study
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-09-05, 1397/06/14
-
Ethics committee reference number
-
IR.MUK.REC.1397.141
Health conditions studied
1
-
Description of health condition studied
-
Knee osteoarthritis
-
ICD-10 code
-
M17
-
ICD-10 code description
-
Osteoarthritis of knee
Primary outcomes
1
-
Description
-
Knee pain severity
-
Timepoint
-
Before the intervention, one month and two month after the last injection
-
Method of measurement
-
Using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
2
-
Description
-
Morning Stiffness
-
Timepoint
-
Before the intervention, one month and two month after the last injection
-
Method of measurement
-
Using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
3
-
Description
-
Physical activity
-
Timepoint
-
Before the intervention, one month and two month after the last injection
-
Method of measurement
-
Using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Intervention groups
1
-
Description
-
Intervention group: In the first intervention group, 8 ml of dextrose 20% and 2 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points.
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group: In the second intervention group 8 ml of dextrose 20% and 2 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Sanandaj 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
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
-
Not applicable
-
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
-
Not applicable
-
Data Dictionary
-
Not applicable