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The effect of discontinuous warm cupping on pain, stiffness and disability of patients with knee osteoarthritis

Protocol summary

Study aim
Determine the effect of discontinuous warm cupping on symptoms of patients with knee osteoarthritis.
Design
This will be a randomized clinical trial. Patients will be randomly matched according to sex. Then, based on the permutation block, they will be divided into two groups of intervention and control. The sample size will be 18 patients in each group.
Settings and conduct
This will be a randomized clinical trial. Patients will be randomly matched according to sex. Then, based on the permutation block, they will be divided into two groups of intervention and control. The sample size will be 18 patients in each group. The site of the research will be the traditional medicine clinic of Gonabad University of Medical Sciences. For patients in the control group, routine care will be provided. For patients in the intervention group, cupping therapy will be performed at the knee joint and on the four sides of the knee.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction and willingness of the patient to participate in the study. Age range 40-60 years. Knee osteoarthritis based on diagnosis of rheumatologist. At least three months have passed from the disease. No-entrance criteria: History of mental, vascular, coagulation, severe deformity and bone structure disorders. No history of knee replacement, Intra-articular injection, Knee joint surgery, History of previous intra-articular fracture. Knee physical therapy based on patient reports. Severe pain during the past month.
Intervention groups
Intervention group: In this group, in addition to the prescribed medications by physician, four season of cupping therapy will be performed. Control group: In this group, patients will receive only prescription medications and no intervention will be performed.
Main outcome variables
Pain؛ Stiffness؛ Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180719040529N1
Registration date: 2018-10-05, 1397/07/13
Registration timing: retrospective

Last update: 2018-10-05, 1397/07/13
Update count: 0
Registration date
2018-10-05, 1397/07/13
Registrant information
Name
Amir Poorgheysar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 5699
Email address
amirpoorgheysar@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
The effect of discontinuous warm cupping on pain, stiffness and disability of patients with knee osteoarthritis
Public title
The effect of discontinuous warm cupping on the symptoms of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction and willingness of the patient to participate in the study Age range 40 to 60 years Knee osteoarthritis based on a diagnosis of rheumatologist (based on the description, clinical symptoms, physical examination, radiological criteria and the kellgren-lawrence grading system) At least three months have passed from the disease
Exclusion criteria:
History of mental illness, vascular disease, coagulation problems, severe deformity and bone building disorder. History of knee replacement, intra articular injection, knee joint surgery, previous fracture inside the articular according to the patient's own report. Knee physiotherapy treatment over last six months. Severe pain experience in the last months
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Actual sample size reached: 36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the evaluator of the outcome of the intervention was blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Education and Research Department, Gonabad University of Medical Sciences, Asiaee Road, Gonabad, Khorasan Razavi Iran
City
Gnabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.GMU.REC.1396.150

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knee pain
Timepoint
Before and after intervention
Method of measurement
Pain Visual Analogue Scale

2

Description
Knee stiffness
Timepoint
Before and after intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index

3

Description
Disability
Timepoint
Before and after intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cupping therapy will be performed four times. Each cupping therapy session time will be about 10-15 minutes.The intervention time will be sixteen days, and every four days a cupping therapy will take place.
Category
Treatment - Other

2

Description
Control group: Patients in this group will receive only medications prescribed by a specialist and no intervention will be performed.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Traditional Medicine clinic
Full name of responsible person
Amir Poorgheysar
Street address
Allame Bohlool Gonabadi Hospital- Sadi Street- Vahdat Blvd - Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
amirpoorgheysar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Seyed Ali Sajjadi
Street address
Education and Research Department, Gonabad University of Medical Sciences, Asiaee Road, Gonabad, Khorasan Razavi Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0805
Email
sa_1344@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amir Poorgheysar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alameh Bohlool Hospital, Gonabadi, Vahdat Blvd, Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
amirpoorgheysar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amir poorgheysar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alameh Bohlool Hospital, Gonabadi, Vahdat Blvd, Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
amirpoorgheysar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amir poorgheysar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alameh Bohlool Hospital, Gonabadi, Vahdat Blvd, Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
amirpoorgheysar@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After receiving the results of the decision for the publication, I will produce results.
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
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