Comparison of the Effectiveness of Intra-articular Prolotherapy versus Peri-articular Prolotherapy on Pain Reduction and Function Improvement in Patients with Knee Osteoarthritis with Effusion
Comparison of the effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and function improvement in patients with knee osteoarthritis with effusion
Design
Two ways randomized blinded parallel clinical trial with 60 participants
Settings and conduct
60 eligible patients with knee osteoarthritis with 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, Intra-articular prolotherapy and Peri-articular prolotherapy. Patients after receiving informations and signing informed consent form, will complete demographic, VAS, WOMAC questionnaires. They will get specified treatment twice, within 2 weeks. Patients will complete the questionnaires in the 4th and 8th week after the first injection. Patients and data analyzer will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with knee osteoarthritis with effusion, aged between 38 to 70 years; both sex; complaining of knee pain; knee crepitation and knee joint stiffness at least for three months before study. Exclusion criteria: having foot deformity; sever Genu Valgum; any infection affecting the knee skin; intra or peri articular injection or knee trauma or fracture for the last three months before the study; knee joints rheumatic or inflammatory disease; total knee arthtoplasty; uncontrolled diabetes with HbA1c more than 7.5%; BMI more than 42; acute lumbosacral radiculopathy or peripheral neuropathy; cancer; bleeding disorders; pregnancy; severe Genu Varum.
Intervention groups
Patients with knee osteoarthritis with effusion will allocate into two groups. The first group drug will be injected in the joint, the second group drug will be injected in specified points around the joint.
Main outcome variables
Pain; Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040209N1
Registration date:2018-08-04, 1397/05/13
Registration timing:prospective
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Pouria Aminsafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
aminsafaei@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 Function Improvement in Patients with Knee Osteoarthritis with Effusion
Public title
Prolotherapy in Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Negative Ballottement Test
Negative Fluid Wave Test
Age from 38 to 70 years in both sexes
Suffering from Knee Osteoarthritis with effusion based on clinical criteria of American College of Rheumatology
Suffering from grades 2 and 3 of Knee Osteoarthritis based on Kellgern and Lawrence Grading Scale
Complain of knee pain at least for three months before study
Knee crepitation at least for three months before study
Knee joint stiffness at least for three months before study
Exclusion criteria:
Foot deformity
Sever Genu Valgum
Any infection affecting the knee skin
Any intra or peri articular injection for the last three months before the study
History of knee joints rheumatic or inflammatory disease
History of total knee arthtoplasty
Uncontrolled diabetes with HbA1c more than 7.5%
BMI more than 42
History of knee trauma or fracture for the last three months before the study
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
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocate in two groups using random number table and will adjust by age and sex.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will randomly allocate into two groups using random number table, while the researcher is blind about the groups. Also, patients are blinded about the group which they were allocated. After the applying the treatment, while assessing the outcomes and analyzing data, the interviewer of outcomes and the analyzing team will be blinded about the groups, respectively.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Shiraz University of Medical Sciences
Street address
School of Medicine, Shiraz University of Medical Sciences, Zand blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.SUMS.MED.REC.1397.089
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 first injections, 4 and 8 weeks after first injection
Method of measurement
Visual Analog Scale (VAS)
2
Description
Function
Timepoint
Before first injections, 4 and 8 weeks after first injection
Method of measurement
The WOMAC questionnaire 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 first group patients lies on bed, patient’s knee with placing a pillow under it flexes to 30 degrees then practitioner prepare the knee and injects 8 ml of 10% hyper tonic dextrose with 2 ml of 2% Lidocaine will be injected in the joint and the injection will repeat two weaks later.
Category
Treatment - Drugs
2
Description
In the second group patients lies on bed, patient’s knee with placing a pillow under it flexes to 30 degrees then practitioner prepare the knee and 5 ml of 20% hyper tonic dextrose with 5 ml of 1% Lidocaine will be injected in specified points around the joint and the injection will repeat two weaks later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Pooria Amin Safaei
Street address
Rajaee Hospital, Chamran Blvd.
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
Pooria Amin Safaei
Street address
Emam Reza Clinic, Namazi Sq., 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.
City
Shiraz
Province
Fars
Postal code
713451978
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
Pooria Amin Safaei
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5645
Email
aminsafaei@sums.ac.ir
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
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
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
Pooria Amin Safaei
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5645
Email
aminsafaei@sums.ac.ir
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