comparison of intra articular prolotherapy versus peri articular prolotherapy on decreasing pain and improvement of the function in patient with knee osteoarthritis
Knee osteoarthritis (KOA) is a common disabling disease. Limited studies have demonstrated that prolotherapy intra-articular or peri-articular be helpful in the treatment of patients with KOA. In the current study, we compared the results between these two treatment methods. In the current randomized clinical trial, 25 patients with KOA were randomly assigned equally into two groups (intra-articular group and peri-articular group). In each group, injections were repeated two times with 10-14 day intervals. Before the treatment and 2 and 4 weeks after the injections, the pain intensity was measured by using a visual analogue scale and the Western Ontario and McMaster university arthritis index scores(WOMAK) and oxford knee scale (OKS)Finally, the results were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091229795N1
Registration date:2016-10-30, 1395/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Farzane Fereydooni
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9040
Email address
fereydooni@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2017-06-30, 1396/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of intra articular prolotherapy versus peri articular prolotherapy on decreasing pain and improvement of the function in patient with knee osteoarthritis
Public title
Evaluation of the effectiveness of prolotherapy on patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion croteria: patient had these symptoms atleast for 1 month joint stiffness; criptation; knee pain.
exclusion criteria: any intra or extra knee jonit injection in past 3 months; total knee arthroplasty; lumbo sacral radiculopathy; uncontrolled diabetic mellitus with HbA1C more than7.5; reumatic disorders such as rheumatoid arthritis,goat, SLE, brucella; knee truma during 3 months ago; knee fracture during 3 months ago; BMI more than 42.
Age
From 38 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Central department, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2016-07-26, 1395/05/05
Ethics committee reference number
ir.sums.med.rec.1395.33
Health conditions studied
1
Description of health condition studied
arthrosis of knee
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
2
Description of health condition studied
arthrosis of knee
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
Primary outcomes
1
Description
pain
Timepoint
befor injection, 2 and 4 weeks after injection
Method of measurement
Visual Analog Scale( VAS)
2
Description
patient function
Timepoint
befor injection and 2 and 4 weeks after injection
Method of measurement
The WOMAC consists of 24 items divided into 3 subscales:Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing.Stiffness (2 items): after first waking and later in the day.Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties
Secondary outcomes
empty
Intervention groups
1
Description
in first group patient lies at bed, patient’s knee with placing a pillow under it flexes to 30 degrees then practitioner prep the knee and injects 5 cc dextrose 25% from inferiolateral side of the knee joint by 23 gauge Syringe.
Preparation of dextrose 25%( 2.5 cc lidocaine2% plus 2.5 cc dextrose 50%)
Category
Treatment - Drugs
2
Description
In second group injects 5cc dextrose 25 % by using 25 gauge syringe around knee joint maximum in two points (lateral or medial) that is the most painful, except pesanserine bursitis.
Preparation of dextrose 25%( 2.5 cc lidocaine2% plus 2.5 cc dextrose 50%)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Hospital
Full name of responsible person
Freydooni farzane
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Emam Raza Clinic
Full name of responsible person
Fereydooni Farzane
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Physical Medicine and Rehabilitation
Full name of responsible person
Davatgar mrs
Street address
Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Physical Medicine and Rehabilitation
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
Department of Physical Medicine and Rehabilitation
Full name of responsible person
Fereydooni Farzane
Position
Resident of Rhysical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
fereydooni.farzane@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Physical Medicine and Rehabilitation
Full name of responsible person
Far por Hamid reza
Position
Assistant professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
farporh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Physical Medicine and Rehabilitation
Full name of responsible person
Fereydooni Farzane
Position
Resident of Rhysical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
00
Fax
Email
fereydooni.farzane@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)