Protocol summary
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Study aim
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Effect of neuromuscular electrical stimulation for endometriosis associated pain
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Design
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Double Blinded Randomized Clinical Trial
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Settings and conduct
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Intervention group: patients in the treatment group received electrical stimulation by using the electrical stimulation device. It applied 2 gel pads attached on the S3 and S4 region with frequency of 85Hz and pulse duration 75ms for 30minutes each session, once daily,3sessions weekly for a total of 10 sessions.
Control group: Patients did not receive electrical stimulation using an electrical stimulation device.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: average age of 18-45 years, patients with endometriosis -associated pain documented endometriosis by MRI or sonography that were undergoing medication.
Exclusion Criteria: Patients with pace maker, Patients who had electrical stimulation in last 1month, patient that having surgical plan in next 3 months or had surgery in last 6 months, uremia, uncontrolled thyroid dysfunction, active lumbosacral radiculopathy, peripheral neuropathy, collagen vascular disease, pregnancy, addiction to drug or alcohol.
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Intervention groups
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Intervention group: patients in the treatment group received electrical stimulation by using the electrical stimulation device. It applied 2 gel pads attached on the S3 and S4 region with frequency of 85Hz and pulse duration 75ms for 30minutes each session, once daily,3sessions weekly for a total of 10 sessions.
Control group: Patients did not receive electrical stimulation using an electrical stimulation device.
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Main outcome variables
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Pain, Quality of Life
General information
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Reason for update
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It was big mistake in trial onset.please correct this.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N107
Registration date:
2021-01-27, 1399/11/08
Registration timing:
prospective
Last update:
2021-02-01, 1399/11/13
Update count:
1
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Registration date
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2021-01-27, 1399/11/08
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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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2021-02-17, 1399/11/29
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Expected recruitment end date
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2021-03-19, 1399/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of neuromuscular electrical stimulation for endometriosis associated pain
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Public title
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Effect of neuromuscular electrical stimulation for endometriosis associated pain
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Average age of 18-45 years
Patients with endometriosis -associated pain
Documented endometriosis by MRI or sonography
Exclusion criteria:
Patients with pace maker
Patients who had electrical stimulation in last 1month
Patient that having surgical plan in next 3 months or had surgery in last 6 months
Uremia
Uncontrolled thyroid dysfunction
Active lumbosacral radiculopathy
Peripheral neuropathy
Collagen vascular disease
Pregnant patients
Patient with addiction to drug or alcohol
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is performed for the two intervention and control groups by using 4, 6 and 8 permutation blocks extracted from the site www.sealedenvelope.com.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2019-08-24, 1398/06/02
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.361
Health conditions studied
1
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Description of health condition studied
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Endometriosis
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ICD-10 code
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N80
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ICD-10 code description
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Endometriosis
Primary outcomes
1
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Description
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Pain
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Timepoint
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هر هفته پس از انجام تحریک الکتریکی
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Method of measurement
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Visual Analogue Scale
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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After Intervention
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Method of measurement
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Moorehead-Ardelt Quality of Life Questionnaire II
Intervention groups
1
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Description
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Intervention group: patients in the treatment group received electrical stimulation by using the electrical stimulation device. It applied 2 gel pads attached on the S3 and S4 region with frequency of 85Hz and pulse duration 75ms for 30minutes each session, once daily,3sessions weekly for a total of 10 sessions.
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Category
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Treatment - Other
2
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Description
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Control group: Patients did not receive electrical stimulation using an electrical stimulation device.
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Category
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N/A
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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Shiraz 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is against our polices.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available