Protocol summary

Study aim
The survey of effect LI 4،SP10 ،SP9، GB34، ST36، ST34 acupressure on severity of knee pain caused by osteoarthritis in the elderly living in the city of Rafsanjan city in 2017
Design
The samples were categorized into three intervention, control and touch group by using stratified randomization method (minimization). The target classes were gender-based.Then the samples were randomly assigned (lottery) to the groups.
Settings and conduct
This study is a randomized clinical trial. And place of the research is all health centers in Rafsanjan
Participants/Inclusion and exclusion criteria
Patients with osteoarthritis in one or both knees Age over 60 years old Having informed consent to participate in the study
Intervention groups
Acupressure intervention is performed by a researcher for three one hour training sessions training sessions for the elderly of the intervention group.Acupressure in this study is pressure applied at the points LI 4, SP10, SP9, GB34, ST36, ST34.
Main outcome variables
Reduce pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180114038366N1
Registration date: 2018-04-13, 1397/01/24
Registration timing: retrospective

Last update: 2018-04-13, 1397/01/24
Update count: 0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Tahere Norozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 8625
Email address
taherenorozi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of acupressure on pain, stiffness and physical function of elderly with knee osteoarthritis
Public title
The effect of acupressure on pain, stiffness and physical function of elderly with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not receiving any supplemental or alternative treatment for osteoarthritis during the last three months Dont have any history of using acupressure for any purpose The absence of any scars, scratches and deformities at points LI 4, SP10, SP9, GB34, ST36, ST34 Ability to speak and understand Persian language Having enough power of visual and auditory Do not use anticoagulants or any coagulation disorder Dont have history of surgery associated with the disease (such as replacement and joint repair) on the joint Having osteoarthritis in one or both diapers for at least three months based on the clinical criteria of the American College of Rheumatology BMI below 40. Having a phone line to track Aged over 60 years Having informed consent to participate in the study Not having advanced neuropathy Non-addiction and lack of chronic use of opiates Failure to inject injections into the knee joint or arthroscopy within 30 days prior to intervention Having enough cognitive and functional strength to learn and implement the intervention Lack of history of topical skin lesions and open wounds in acupressure areas, other autoimmune diseases, including lupus erythematosus, have chronic neuropathic conditions such as diabetes.
Exclusion criteria:
Having previous history of acupressure Reduced level of consciousness Patients who do not cooperate for any reason until the end of the intervention Patients who have acute pressure at the points LI4, SP10, SP9, GB34, ST36, ST34 have no feeling of warmth, heaviness, swelling or anesthesia at this point Unwillingness to cooperate with each research unit during the study Injection of housing into the knee joint during the intervention period Those who need to receive housing during the intervention until the second and third assessment of the severity of pain. Lower limb and upper limb Having mental illness during the intervention period
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Ali ibn Abitaleb Hospital - Imam Ali Blvd - Head Office of Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.RUMS.REC.1396.121

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified

Primary outcomes

1

Description
pain
Timepoint
21 day
Method of measurement
WOMAC questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Acupressure at LIV3 LI11, LI4 and ST 36 points.
Category
Rehabilitation

2

Description
Intervention group 2: Only touch without pressure at, LIV3 LI11, LI4 and ST 36.
Category
Rehabilitation

3

Description
Control group: This group did not receive any acupressure treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Rafsanjan
Full name of responsible person
Ali Mozafari
Street address
Ali Ibn Abitaleb Hospital, Mofatat Blvd, Rafsanjan-
City
Rafsanjan
Province
Kerman
Postal code
7717937833
Phone
+98 34 3428 0000
Email
AMOZAFARI2001@Yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
University Headquarters, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
717937833
Phone
+98 34 3438 0040
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ansari Jaberi
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Midwifery Faculty, Modarres Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34255900
Email
A_ansari@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ansari Jaberi
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Midwifery Faculty, Modarres Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34255900
Email
A_ansari@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tahere Norozi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alley 3, Shahid Dehghan Rajabi Ave, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937833
Phone
+98 34 3428 8625
Email
taherenorozi@yahoo.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
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