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Protocol summary
Cheking the effect of acupancture on muscle cramp in dislysis pt
Cheking the effect of acupancture on muscle cramp in dislysis patients
Cheking the effect of acupancture on muscle cramp in dislysis ptpatients
General information
2019-04-21, 1398/02/01
2020-01-15, 1398/10/25
20192020-0401-2115 00:00:00
2019-09-27, 1398/07/05
2020-07-31, 1399/05/10
20192020-0907-2731 00:00:00
2019-04-21, 1398/02/01
2020-01-15, 1398/10/25
20192020-0401-2115 00:00:00
2019-09-27, 1398/07/05
2020-07-31, 1399/05/10
20192020-0907-2731 00:00:00
2019-10-02, 1398/07/10
2020-07-31, 1399/05/10
20192020-1007-0231 00:00:00
empty
Modification of recruitment date
Modification of recruitment date
empty
اصلاح تاریخ جمع اوری نمونه
اصلاح تاریخ جمع اوری نمونه
Cheking the effect of acupancture on muscle cramp in dialysis paitient
Cheking the effect of acupancture on muscle cramp in dialysis patient
Cheking the effect of acupancture on muscle cramp in dialysis paitientpatient
Recruitment centers
#1
Name of recruitment center - English: Namazi hospital-faghihi hospital
Name of recruitment center - Persian: بيمارستان نمازي بيمارستان فقيهي
Full name of responsible person - English: Dr Alireza dabaghmanesh
Full name of responsible person - Persian: دكتر عليرضا دباغ منش
Street address - English: Namazi squer
Street address - Persian: ميدان نمازي
City - English: Shiraz
City - Persian: شيراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ٧١٨٤٨٣٩١١١
Phone: +98 71 3647 4332
Fax:
Email: Vejdanpak.maryam@gmail.com
Web page address:
Name of recruitment center - English: Namazi hospital-Faghihi hospital
Name of recruitment center - Persian: بيمارستان نمازي بيمارستان فقيهي
Full name of responsible person - English: Dr Alireza Dabaghmanesh
Full name of responsible person - Persian: دكتر عليرضا دباغ منش
Street address - English: Namazi Squer
Street address - Persian: ميدان نمازي
City - English: Shiraz
City - Persian: شيراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ٧١٨٤٨٣٩١١١
Phone: +98 71 3647 4332
Fax:
Email: Vejdanpak.maryam@gmail.com
Web page address:
Name of recruitment center - English: Namazi hospital-faghihiFaghihi hospital Name of recruitment center - Persian: بيمارستان نمازي بيمارستان فقيهي Full name of responsible person - English: Dr Alireza dabaghmaneshDabaghmanesh Full name of responsible person - Persian: دكتر عليرضا دباغ منش Street address - English: Namazi squerSquer Street address - Persian: ميدان نمازي City - English: Shiraz City - Persian: شيراز Province: Fars Country: Iran (Islamic Republic of) Postal code: ٧١٨٤٨٣٩١١١ Phone: +98 71 3647 4332 Fax: Email: Vejdanpak.maryam@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr ahmad bazoojoo
Full name of responsible person - Persian: دكتر احمد بازوجو
Street address - English: Setad blv
Street address - Persian: بلوار ستاد
City - English: Shiraz
City - Persian: شيراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134845794
Phone: +98 71 3230 5884
Fax:
Email: medravabet@sums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Ahmad Bazoojoo
Full name of responsible person - Persian: دكتر احمد بازوجو
Street address - English: Setad Blv
Street address - Persian: بلوار ستاد
City - English: Shiraz
City - Persian: شيراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134845794
Phone: +98 71 3230 5884
Fax:
Email: Medravabet@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr ahmad bazoojooAhmad Bazoojoo Full name of responsible person - Persian: دكتر احمد بازوجو Street address - English: Setad blvBlv Street address - Persian: بلوار ستاد City - English: Shiraz City - Persian: شيراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134845794 Phone: +98 71 3230 5884 Fax: Email: medravabetMedravabet@sums.ac.ir Web page address:
Protocol summary
Study aim
Cheking the effect of acupancture on muscle cramp in dislysis patients
Design
This study is a single-blind clinical trial. Based on this, 60 patients are selected and severity and frequency of muscle cramps are randomly divided into two groups. Drugs used. 15 minutes before hemodialysis, the control group is operated. Interventions in the case group are in acupuncture.
Settings and conduct
The study starts by collecting patients in dialysis ward of nemazee and faghihi Shiraz and acupuncture in physiotherapy and rehabilitation clinics by medical students and relevant rehabilitation specialist professors after getting the testimonial will continue
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with chronic renal failure who were treated with hemodialysis;History of cramp have frequent muscle; at the time of sampling on the list are not linked;Infectious diseases, acute articular rheumatism, skin diseases, wounds, open fractures, deep vein thrombosis, Burns, and arm or leg amputation is not; particular anticoagulant drugs such as vitamin E and the pain is not used
Intervention groups
Intervention group: Acupuncture plus routine medical treatment of pre-existing muscle cramps Control group: Routine medical treatment of muscle cramps according to physician's prescription
Main outcome variables
muscle cramps during or after dialysis- consumer medication side effects
General information
Reason for update
Modification of recruitment date
Acronym
IRCT registration information
IRCT registration number:IRCT20181121041716N1
Registration date:2019-12-16, 1398/09/25
Registration timing:prospective
Last update:2023-06-06, 1402/03/16
Update count:1
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Maryam Vejdanpak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 2718
Email address
vejdanpak_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
2020-01-15, 1398/10/25
Actual recruitment end date
2020-07-31, 1399/05/10
Trial completion date
2020-07-31, 1399/05/10
Scientific title
Cheking the effect of acupancture on muscle cramp in dialysis patient
Public title
Acupancture in dyalisis paitient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic renal failure who were treated with hemodialysis;
History of frequent muscle cramp;
At least 6 months last from the time start dialysis;
Not have been in the transplant list at the time of sampeling
Three times a week became dialysis with bicarbonates and each time lasts for 4 hours
Exclusion criteria:
Infectious dx
Anticoagulant agent
Pt with active Radicolopathy
Skin dx
Rhomatoid Arteritis
Vit E
Analgesic drugs
Lumbosacral Discopathy
Spinal canal stenosis
Symptomatic Lumbosacral
Peripheral Neuropathy
Restless leg syndrome
Iron deficiency anemia (ferritin less than 50)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Statistical software randomization
Individual random unit
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants
put needle on the foot of the patients who have not received the medication that we're pretending to do acupuncture
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Univercity of Medical Sciences
Street address
Setad Ave
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.SUMS.MED.REC.1397.480
Health conditions studied
1
Description of health condition studied
Mucsle cramp in dialysis peitient
ICD-10 code
M62.00
ICD-10 code description
Separation of muscle (nontraumatic), unspecified site
Primary outcomes
1
Description
1) cramp frequency
Timepoint
before and after acupancture and one mounth after finishing procidure
Method of measurement
questioner of amounth of number of muscle cramp
2
Description
cramp severity
Timepoint
before and after acupancture and one mounth after finishing procidure
Method of measurement
questioner of amounth of number of muscle cramp
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acupuncture plus routine medical treatment of pre-existing muscle cramps
Category
Treatment - Other
2
Description
Control group: Routine medical treatment of muscle cramps according to physician's prescription
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital-Faghihi hospital
Full name of responsible person
Dr Alireza Dabaghmanesh
Street address
Namazi Squer
City
Shiraz
Province
Fars
Postal code
٧١٨٤٨٣٩١١١
Phone
+98 71 3647 4332
Email
Vejdanpak.maryam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr Ahmad Bazoojoo
Street address
Setad Blv
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
Medravabet@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Maryam Vejdanpak
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Rehabilitation
Street address
Farhangshahr Street -Fatemi fard Ave
City
Shiraz
Province
Fars
Postal code
٧١٨٤٨٣٩١١١
Phone
+98 71 3230 5410
Email
Vejdanpak.maryam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Professor of Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Farhangshahr Street
City
Shiraz
Province
Fars
Postal code
٧١٨٤٨٣٩١١١
Phone
+98 71 3230 5410
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
Maryam Vejdanpak
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Rehabilitation
Street address
Farhangshahr Blvd- Zabihollah Shokouh Ave
City
Shiraz
Province
Fars
Postal code
7184839111
Phone
+98 71 3230 5410
Email
Vejdanpak.maryam@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
Based on editor opinion
When the data will become available and for how long
Based on editor opinion
To whom data/document is available
Based on editor opinion
Under which criteria data/document could be used
Based on editor opinion
From where data/document is obtainable
Based on editor opinion
What processes are involved for a request to access data/document