Comparison of the effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis without effusion
Comparison of the Intra-articular Prolotherapy versus Peri-articular
Prolotherapy on pain reduction and improving of function in
patients with knee osteoarthritis without effusion
Design
Blocked randomized, two ways, blinded parallel clinical trial
Settings and conduct
60 eligible patients with knee osteoarthritis without effusion who were referred to Physical Medicine and Rehabilitation Clinics of Shiraz University of Medical Sciences, will be randomly assigned to two parallel treatment groups, A: Intra-articular prolotherapy and B: Peri-articular prolotherapy. Patients after receiving informations and signing informed consent form, will complete demographic, VAS, WOMAC and OKS questionnaires. Then , based on the allocated group, they will get specified treatment twice, within 2 weeks. Patients will complete the questionnaires in the 4th and 8th week based on the first injection. Patients and data analyzer will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient suffering from joint stiffness; criptation; knee pain for at least for 3 month. Exclusion criteria: any intra or extra knee joint injection in the past 3 months; total knee arthroplasty; lumbosacral radiculopathy; uncontrolled diabetic mellitus with HbA1C more than7.5%; rheumatic disorders; knee trauma during 3 months ago; knee fracture during 3 months ago; BMI over 42.
Intervention groups
The first group involve the patients with knee osteoarthritis without effusion that will undergo intra-articular injection.
The second group involve the patients with knee osteoarthritis without effusion that will undergo peri-articular injection
Main outcome variables
Pain، Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171111037396N1
Registration date:2018-07-18, 1397/04/27
Registration timing:prospective
Last update:2018-07-18, 1397/04/27
Update count:0
Registration date
2018-07-18, 1397/04/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 737 9584
Email address
dashtimakan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis without effusion
Public title
Prolotherapy in Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Negative Ballottement test
Negative Fluid wave test
Age from 38 years old to 70 years old of both sex
Diagnosed as knee osteoarthritis according to clinical criteria of American College of Rheumatology
Having grade 2 and 3 based on Kellgern and Lawrence Grading Scale
Complain of pain, crepitation and knee joint stiffness that lasted at least three months before study
Exclusion criteria:
Foot deformity
Sever genu valgum
Any infection involving the knee skin
Any intra or peri articular injection during the three last months
History of rheumatic or inflammatory disease involving the knee joints
Prior total knee arthtoplasty
Poorly controlled DM with HbA1c more than 7.5%
BMI more than 42
History of knee trauma or fracture during the three last months
History of acute lumbosacral radiculopathy or peripheral neuropathy
History of cancer
Bleeding disorders
Pregnancy
Severe genu varum
Age
From 38 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly allocate 60 eligible subjects to two parallel groups: Intra-articular injection as group A and Peri-articular injection as group B by the administrator of the clinician who educated to use a block randomization list. The list is made by computer as non-stratified list, with the equal block length. The patients will be not aware of being allocated in the group A or B. Also, statisticians will be kept blind about the allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be allocated by blocked randomization list to 2 groups by investigator A :Intraarticular prolotherapy and B:Periarticular prolotherapy. the patients will be not aware of being allocated in the group A or B. In both groups the investigator will inject the prolotherapy agent.The patients will be visited by a second colleague who will be not aware of the groups during the study.outcome assessor will be not blind but statisticians will be kept blind about the allocation.
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 Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.SUMS.MED.REC.1397.88
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Before injection, 4 and 8 weeks after injection
Method of measurement
Visual Analog Scale (VAS)
2
Description
Function
Timepoint
Befor injection and 2 and 4 weeks after injection
Method of measurement
The WOMAC consists of 24 items divided into 3 sub scales : 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 the group A patient lies on bed, patient’s knee with placing a pillow under it flexes to 30 degrees then practitioner prepare 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 the group B, 5 cc of dextrose 25% will be injected by using 25 gauge syringe around knee joint maximum in two points (lateral or medial). These points are the most painful points, 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
Rajaee Hospital
Full name of responsible person
Dashtimakan Hadi
Street address
Rajaee Hospital, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
rajaeehospital@sums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Raza Clinic
Full name of responsible person
Dashtimakan Hadi
Street address
Emam Reza Clinic, Namazi Square, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd. Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dashtimakan Hadi
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shiraz School of Medicine, Shiraz University of Medical Science, Zand Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3233 7855
Email
hadidashtimakan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rooshanzamir Sharareh
Position
Assistant Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 9040
Email
sharareh.roshanzamir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dashtimakan Hadi
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shiraz School of Medicine, Zand Blvd. Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3233 7855
Email
hadidashtimakan@gmail.com
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