Protocol summary

Study aim
Evaluation of the effect of 12-point foot (lower extremity) ghams in the treatment of knee pain (knee pain)
Design
This study is double-blind, placebo-controlled, randomized clinical trial
Settings and conduct
This study is conducted in several clinical centers.
Participants/Inclusion and exclusion criteria
Included criteria: complete vigilance and satisfaction; age over 35 years old; diagnosis of osteoarthritis according to the American Society of Rheumatology ( Having knee pain and having at least 5 of the 8 cases listed below: Age greater than 50 years; Stiffness < 30 minutes; Crepitus; Bony tenderness; Bony enlargement; No palpable warmth; ESR < 40 mm/hr; Rheumatoid Factor (RF) < 1:40); not using a variety of complementary therapies during the previous three months; lack of personalized sedative medications and drug by the patient; absence of severe neuropathy in the patient; healthy areas under massage; lack of mental retardation, blindness and deafness. The absence of rheumatoid arthritis, fibromyalgia, acute or recurrent pseudoravirus, malignancy, internal disease, Such as kidney or liver disorder, gastrointestinal bleeding, asthma requiring corticosteroid administration; no use of corticosteroid in less than 5 weeks, injection of knee depoocorticosteroid in less than 3 months old or intra-articular hyaluronate in less than 6 months; lack of arthroscopy over the past year; no significant damage to the knee in less than 6 months; insensitivity and ulcer in the knee; ability to learn 12 ghams points.
Intervention groups
12-point foot (lower extremity) ghams
Main outcome variables
1- Knee injury and Osteoarthritis Outcome Score 2- VAS Questionnaire 3- Taking the Diclofenac drug

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181130041802N1
Registration date: 2019-02-03, 1397/11/14
Registration timing: registered_while_recruiting

Last update: 2019-02-03, 1397/11/14
Update count: 0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Maryam Alinaghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 4390
Email address
forqanimhd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 12 point inferior extremity ghams on knee pain relief
Public title
Ghams inferior extremity on knee pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete vigilance and satisfaction. Age over 35 years old. Diagnosis of osteoarthritis according to the American Society of Rheumatology: Having knee pain and having at least 5 of the 8 cases Not using a variety of complementary therapies during the previous three months Lack of personalized sedative medications and drug by the patient The absence of severe neuropathy in the patient. Healthy areas under massage Lack of mental retardation, blindness and deafness. The absence of rheumatoid arthritis, fibromyalgia, acute or recurrent pseudoravirus, malignancy, internal disease, Such as kidney or liver disorder, gastrointestinal bleeding, asthma requiring corticosteroid administration Non-use of corticosteroid in less than 5 weeks, injection of knee depoocorticosteroid in less than 3 months old or intra-articular hyaluronate in less than 6 months A lack of arthroscopy over the past year No significant damage to the knee in less than 6 months Insensitivity and ulcer in the knee. Ability to learn 12 ghams points
Exclusion criteria:
Using a variety of complementary therapies during the previous three months Personalized sedative medications and drug by the patient Severe neuropathy in the patient Having mental retardation, blindness and deafness. having the rheumatoid arthritis, fibromyalgia, acute or recurrent pseudoravirus, malignancy, internal disease, Such as kidney or liver disorder, gastrointestinal bleeding, asthma requiring corticosteroid administration Use of corticosteroid in less than 5 weeks, injection of knee depoocorticosteroid in less than 3 months old or intra-articular hyaluronate in less than 6 months Arthroscopy over the past year Significant damage to the knee in less than 6 months Sensitivity and ulcer in the knee
Age
From 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization, 80 numbers were written on 80 paper and placed inside a bag. The numbers were randomly and blindly removed from the bag. 40 first issues as intervention group and 40 second ones as control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants, as well as researchers or evaluators, are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Designed for the first time

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Office of Tehran University of Medical Sciences, Ghodss St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-08-31, 1397/06/09
Ethics committee reference number
IR.TUMS.VCR.REC.1397.388

Health conditions studied

1

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

Primary outcomes

1

Description
Knee Pain
Timepoint
Before the study 0, Sixth day, Fourteenth day
Method of measurement
Knee injury and Osteoarthritis Outcome Score, Visual Analogue Scale

Secondary outcomes

1

Description
Diclofenac drug intake
Timepoint
Fourteenth day
Method of measurement
Number

Intervention groups

1

Description
Intervention group:
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahmadieh traditional medicine treatment center
Full name of responsible person
Maliheh Tabraee
Street address
Sarparast st., Palestine Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۶۶۶۳۶۱
Phone
+98 21 8897 6527
Fax
+98 21 8899 0829
Email
forqanimhd@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraian
Street address
Keshavarz Blvd., Ghods St., Central Organization of the University, 6th floor of Research and Technology Department
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Alinaghizadeh
Position
Ph.D. Candidate of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unite 1, Floor 8, Baharan Complex, No. 15, Javanshir St.
City
Tehran
Province
Tehran
Postal code
1668848755
Phone
+98 21 2296 4390
Email
forqanimhd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Alinaghizadeh
Position
Ph.D. Candidate of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unite 1, Floor 8, Baharan Complex, No. 15, Javanshir St.
City
Tehran
Province
Tehran
Postal code
1668848755
Phone
+98 21 2296 4390
Email
forqanimhd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Alinaghizadeh
Position
Ph.D. Candidate of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unite 1, Floor 8, Baharan Complex, No. 15, Javanshir St.
City
Tehran
Province
Tehran
Postal code
1668848755
Phone
+98 21 2296 4390
Fax
Email
Forqanimhd@gmail.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 Data
When the data will become available and for how long
6 months after printing results
To whom data/document is available
All People
Under which criteria data/document could be used
Maintaining intellectual rights
From where data/document is obtainable
Maryam Alinaghizadeh
What processes are involved for a request to access data/document
A written request by sending an email and receiving an answer within 10 days
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