Protocol summary
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Study aim
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-Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women referring to Yas Hospital in 2019
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Design
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Controlled parallel randomized clinical trial on 60 patients
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Settings and conduct
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A total of 60 women with chronic pelvic pain, 30 patients in radiofrequency intervention group and 30 patients in physiotherapy intervention group, are included in this study in Yas Hospital, Tehran, iran. The intervention is heat controlled radiofrequency or physiotherapy for treatment of chronic pelvic pain. Finally, the intensity of pain, pelvic floor muscle strength, pelvic floor muscle tonicity and muscle endurance are compared between groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Chronic pelvic pain. Exclusion criteria: using drugs for treatment of chronic pelvic pain.
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Intervention groups
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Intervention group includes women with chronic pelvic pain that are treated with heat controlled radiofrequency or physiotherapy.
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Main outcome variables
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Pain; Pelvic floor strength; Pelvic floor tonicity; Muscle endurance
General information
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Reason for update
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Error in data entry
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200311046746N2
Registration date:
2020-09-20, 1399/06/30
Registration timing:
prospective
Last update:
2021-07-03, 1400/04/12
Update count:
1
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Registration date
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2020-09-20, 1399/06/30
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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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2020-09-22, 1399/07/01
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Expected recruitment end date
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2021-03-10, 1399/12/20
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Actual recruitment start date
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2020-09-22, 1399/07/01
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Actual recruitment end date
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2021-03-10, 1399/12/20
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Trial completion date
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2021-04-19, 1400/01/30
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Scientific title
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Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women
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Public title
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Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Chronic pelvic pain
Exclusion criteria:
Medication for treatment of chronic pelvic pain
Pelvic region malignancies
Pregnancy, breastfeeding, and other related medical conditions
Urinary tract infections and vaginal infections
Neurological disease such as MS, CVA, and spinabifida
Abnormal mental status
Abnormal pap smear
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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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:
46
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are allocated into the case and control groups using permuted balance block randomization. The blocks are four. Using STATA software, random numbers are generated from 1 to 6. Another number is generated when the previous number is more than 6, without considering it. An individual prepare the random numbers and put them in pockets with a five-digit serial number. All pockets open after including a patient, and the patient allocates to a group.
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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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2019-06-01, 1398/03/11
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1398.162
Health conditions studied
1
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Description of health condition studied
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Chronic pelvic pain
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain
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Timepoint
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Before the intervention, after 6 weeks and after 3 months
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Method of measurement
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Visual analog scale
2
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Description
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Pelvic floor muscle strength
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Timepoint
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Before the intervention, after 6 weeks and after 3 months
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Method of measurement
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Clinical examination
3
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Description
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Pelvic floor muscle tonicity
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Timepoint
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Before the intervention, after 6 weeks and after 3 months
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Method of measurement
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Clinical examination
4
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Description
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Muscle endurance
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Timepoint
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Before the intervention, after 6 weeks and after 3 months
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Method of measurement
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Clinical examination
Intervention groups
1
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Description
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Intervention group: Radiofrequency treatment. Patients undergo a Radiofrequency twice a month for 12 weeks in Yas hospital, Tehran. Each session we are going to assess patients satisfaction using VAS.
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Category
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Treatment - Other
2
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Description
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Intervention group: Physiotherapy treatment. Patients undergo a Physiotherapy once a week for 12 weeks in Yas hospital, Tehran. Each session we are going to assess patients satisfaction using VAS.
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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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Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available