Protocol summary
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Study aim
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Cheking the effect of acupancture on muscle cramp in dislysis patients
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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muscle cramps during or after dialysis- consumer medication side effects
General information
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Reason for update
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Modification of recruitment date
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Acronym
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IRCT registration information
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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
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Registration date
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2019-12-16, 1398/09/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-15, 1398/10/25
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Expected recruitment end date
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2020-07-31, 1399/05/10
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Actual recruitment start date
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2020-01-15, 1398/10/25
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Actual recruitment end date
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2020-07-31, 1399/05/10
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Trial completion date
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2020-07-31, 1399/05/10
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Scientific title
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Cheking the effect of acupancture on muscle cramp in dialysis patient
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Public title
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Acupancture in dyalisis paitient
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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block randomization
Statistical software randomization
Individual random unit
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants
put needle on the foot of the patients who have not received the medication that we're pretending to do acupuncture
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-23, 1397/11/03
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Ethics committee reference number
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IR.SUMS.MED.REC.1397.480
Health conditions studied
1
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Description of health condition studied
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Mucsle cramp in dialysis peitient
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ICD-10 code
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M62.00
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ICD-10 code description
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Separation of muscle (nontraumatic), unspecified site
Primary outcomes
1
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Description
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1) cramp frequency
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Timepoint
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before and after acupancture and one mounth after finishing procidure
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Method of measurement
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questioner of amounth of number of muscle cramp
2
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Description
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cramp severity
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Timepoint
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before and after acupancture and one mounth after finishing procidure
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Method of measurement
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questioner of amounth of number of muscle cramp
Intervention groups
1
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Description
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Intervention group: Acupuncture plus routine medical treatment of pre-existing muscle cramps
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Category
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Treatment - Other
2
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Description
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Control group: Routine medical treatment of muscle cramps according to physician's prescription
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Fasa University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Based on editor opinion
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When the data will become available and for how long
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Based on editor opinion
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To whom data/document is available
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Based on editor opinion
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Under which criteria data/document could be used
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Based on editor opinion
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From where data/document is obtainable
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Based on editor opinion
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What processes are involved for a request to access data/document
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Based on editor opinion
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Comments
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