The comparison Trial of Dextrose Prolotherapy compared to Corticosteroid injection for the treatment of symptomatic first carpometacarpal joint osteoarthritis
Purpose: The comparison of the effectiveness of Dextrose and Corticosteroid injections on pain score reduction and functional improvement of hand, among people suffering from symptomatic first carpometacarpal joint osteoarthritis. Design: In the Physical medicine and Rehabilitation clinic of Imam reza Hospital, 30 hands are Randomized to each treatment arm,. The injections are intraarticular. We evaluate patients prior to the injection, then 1 , 2 and 6 months after the last injection. We measure the amount of pain on VAS scale, the hand functional assessment on HAQ-I scale and the gripping power on Pinch gauge. Inclusion criteria: First CMC joint osteoarthritis with pain and gripping disorder. Exclusion criteria: History of joint injury or injection in the prior 6 months. Intervention: in experimental group:10%Dextrose solution (3 injections monthly) and in control group: Methylprednisolone acetate solution ( 1 injection). Primary outcome: Decrease pain score >20% (6 months follow up). Secondary outcome :Grip strength and Functional assessment of hand.(6 months follow up). Side effects are recorded if any .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011025088N1
Registration date:2011-01-15, 1389/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-15, 1389/10/25
Registrant information
Name
Azadeh Jahangiri
Name of organization / entity
Army 501 (Imam reza hospital)
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 2098
Email address
journals@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2010-03-01, 1388/12/10
Expected recruitment end date
2011-03-01, 1389/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison Trial of Dextrose Prolotherapy compared to Corticosteroid injection for the treatment of symptomatic first carpometacarpal joint osteoarthritis
Public title
The comparison of the effectiveness of two injectable medications for the treatment of hand osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:1-Age>40 2-First carpometacarpal joint pain over 3/10 on VAS scale with symptoms present greater than 3 months 3-Confirmation of CMC osteoarthritis with radiography 4-The Gripping disorder in functional assessment scores 5-Ability to make follow up visits over the 6-month protocol. Exclusion:1-Recent trauma to the hand or fractures seen on radiographs 2-History of joint inflammatory or infectious disorder 3-Allergies to injected solutions 4-CMC joint injections in the prior 6 months.
Age
From 40 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
501 Army university (research group)
Street address
Etemadzade street, west fatemi
City
Tehran
Postal code
1411718541
Approval date
2010-06-30, 1389/04/09
Ethics committee reference number
1019
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15, M16,
ICD-10 code description
Arthrosis
Primary outcomes
1
Description
Pain
Timepoint
Before injection and 1, 2 and 6 months after the last injection
Method of measurement
VAS scale
Secondary outcomes
1
Description
Hand function and pinch grip strength
Timepoint
Before injection and 1, 2 and 6 months after the last injection