Assessment of the effect of Leech therapy on knee osteoarthritis pain and daily functioning of the elderly
Design
Clinical trial with control group, single group, no blinding, randomized stratified block, phase 2 on 80 patients, A random number table is used for randomization
Settings and conduct
After referring the elderly to the orthopedic clinic and confirming the diagnosis of osteoarthritis by an orthopedic specialist, explaining the research objectives for the elderly, obtaining informed consent, dividing into two groups of 40 people with random stratified obstruction and evaluating pain, joint stiffness and physical function with Osteoarthritis Index of Western Ontario and McMaster Universities
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being 60-74 years old
Having grade 3 osteoarthritis
Having moderate pain based on visual analog criteria with a score of (4-7)
Having a BMI (body mass index) above 18.5 and below 30
Have a daily performance score above 34
Exclusion criteria:
Creating acute medical conditions
Elderly deaths during study time
Intervention groups
In the intervention group, a 30-minute leech treatment session using 6 to 8 leeches will be performed in a clean and secluded room while maintaining the patient's privacy in the traditional medicine clinic environment. Before using leeches, the skin in the tibio-femoral area is rinsed with a sharp, sterile needle after rinsing with serum to release a few small drops of blood to stimulate the leeches to suck blood and then 6 to 8 leeches will be placed in the area for 30 minutes.
The control group receives routine treatment as usual and does not receive any intervention from the researcher.
Main outcome variables
change in pain; change in joint dryness; reducing the poly pharmacy phenomenon; improve the daily functioning of the elderly and improve the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170514033961N8
Registration date:2021-11-08, 1400/08/17
Registration timing:registered_while_recruiting
Last update:2021-11-08, 1400/08/17
Update count:0
Registration date
2021-11-08, 1400/08/17
Registrant information
Name
Mandana Saki
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3331 6465
Email address
m.saki@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Leech Therapy on knee osteoarthritis pain and daily functioning of the elderly
Public title
"Evaluation of the effect of Leech Therapy on knee osteoarthritis"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60-74 (young elderly)
Independence of others in daily activities
Lack of neurological diseases associated with movement and balance disorders
Having grade 3 (middle class) osteoarthritis according to the American College of Rheumatology classification criteria
Having moderate pain based on visual analog scale with a score of (4-7)
Failure to perform physiotherapy and knee surgery in the last 12 months
Having satisfaction consciously to participate in the study
No coagulation disorders and cardiovascular disease according to clinical history
No use drugs
No history of joint replacement in the lower limb
No intra-articular injection of steroids in the last 6 months
Having a BMI (body mass index) above 18.5 and below 30
Have a daily performance score above 34
Do not use complementary medicine methods and herbs in the field of osteoarthritis
Exclusion criteria:
Occurrence of acute medical conditions such as anaphylactic shock and stroke during the study
Elderly deaths during the study
Withdrawal from the study despite initial agreement
Sensitivity to leeches
Existence of cognitive disorders based on the physician's opinion and the patient's previous medical history
Secondary osteoarthritis in rheumatic diseases
Use of leech therapy individually in the control group or other complementary medicine methods in both groups
Age
From 60 years old to 74 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are placed in two groups of intervention and control group using random blocks (4). The method of assigning 80 samples to the two groups of intervention and control will be such that considering gender (male_woman) and body mass index (normal category and overweight category) as a class, the method of 4 random blocks for Assigning patients to two groups A (intervention) and group B (control) will be used. The normal category is the body mass index (18.5_25) and the overweight category (25_30). To do this, in older men and women, first a list of blocks will be written and numbers will be assigned to them. - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then using a table of random numbers and randomly select numbers between 1 to 6 and finally the list of treatment assignments based on A sequence of letters A and B will be formed. Depending on the type of intervention and the awareness of the samples of the intervention they receive, blinding is not possible in the participants. But to reduce bias, we will try not to let the data collector and statistical analyst know which information belongs to which group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study has an intervention group and a control group for comparison
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Lorestan, Khorramabad, Road, Pardis University Complex University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.LUMS.REC.1400.127
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain score
Timepoint
At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention
Method of measurement
Osteoarthritis Index of the University of Western Ontario and McMaster
2
Description
Joint dryness score
Timepoint
At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention
Method of measurement
Osteoarthritis Index of the University of Western Ontario and McMaster
3
Description
Daily performance score
Timepoint
At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention
Method of measurement
Osteoarthritis Index of the University of Western Ontario and McMaster
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatment, a 30-minute leech therapy session using 6 to 8 medical leeches (sankumukhi type) in a clean, secluded room while maintaining patient privacy and following all coronavirus protection protocols in a traditional medicine clinic environment will be done.Also continue your treatment routine during the intervention
Category
Rehabilitation
2
Description
Control group: They will receive routine treatment and will not receive any intervention from the researcher and will be considered for comparison with the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic office
Full name of responsible person
Mandana Saki
Street address
No. 18, Rose Alley, Enghelab St., Khorramabad, Lorestan
City
Hamadan
Province
Hamadan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Falahi Ebrahim
Street address
Vice Chancellor for Research and Technology, Lorestan, Khorramabad, Road, Pardis University Complex University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6861915857
Phone
+98 66 3312 0172
Fax
+98 66 3312 0140
Email
edu-res@lums.ac.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Saki Mandana
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 18, Rose Alley, Enghelab St., Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Saki Mandana
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 18, Rose Alley, Enghelab St., Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Saki Mandana
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 18, Rose Alley, Enghelab St., Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is released after unidentifiable individuals in the form of original message information
When the data will become available and for how long
The access period will start from 2021
To whom data/document is available
Based on evidence-based medicine, if it is effective in improving the symptoms in patients with osteoarthritis of the knee, this method can be used in the clinical environment and in order to strengthen the results of previous research, we will do this research..All researchers, teachers, and medical students can download the published article from the relevant journal.
Under which criteria data/document could be used
Unidentifiable data will be made available to health researchers for the study of meta-analysis.
From where data/document is obtainable
Send email to Mandana Saki m.saki@modares.ac.ir
What processes are involved for a request to access data/document
After sending the documents by the applicant researcher via email,the data will be sent two weeks later