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Comparison of the effect of capacitive-resistive electrical transfer (tecar therapy) and sham- tecar therapy in chronic pelvic pain

Protocol summary

Study aim
Determining the effect of Tecar therapy in chronic pelvic pain; Determining and comparing the mean score of fear of movement and quality of life scale in both groups before, after 10 sessions and 3mon after treatment; Determining and comparing the average pain score in both groups before treatment, after 10 sessions and 3,6mon after treatment
Design
A hidden, randomized, double-blind, sham-controlled clinical trial with 44 patients, phase 3,evaluation before and after treatment and 3 and 6 months after the end of treatment.
Settings and conduct
Advertisements in the clinics of Firouzgar Hospital. the participant and the evaluator will not be informed of the groups and the patients with chronic pelvic pain in the intervention and control groups placed. Both groups will receive pelvic floor exercises with Surface EMG biofeedback for 10sessions(up to1.5m). In the intervention group, patients receive 10sessions of Tecar therapy with the WINBACK device on painful points for 15m of capacitive electric transfer (40% intensity) and 10min of resistive electric transfer (40% intensity). Patients in the control group also receive 10sessions. The probe will be placed on the pain points, but the device will be off (SHAM).
Participants/Inclusion and exclusion criteria
At least 18 years of age with chronic pelvic pain, at least one trigger point in the pelvic area; Not having an active organic disease, diabetes, high skin sensitivity, fibromyalgia and serious mental disorders; No history of cancer, pelvic surgery, chemotherapy and pelvic radiotherapy
Intervention groups
Intervention is biofeedback and Tecar, biofeedback performed in both control and intervention groups. Tecar in intervention and sham tecar performed in intervention group.
Main outcome variables
Chronic pelvic pain; mean score of fear of movement; quality of life scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151020024621N9
Registration date: 2024-04-15, 1403/01/27
Registration timing: registered_while_recruiting

Last update: 2024-04-15, 1403/01/27
Update count: 0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
Tannaz Ahadi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 8207
Email address
ahadi.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-09-19, 1403/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of capacitive-resistive electrical transfer (tecar therapy) and sham- tecar therapy in chronic pelvic pain
Public title
The effect of tecar therapy in chronic pelvic pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than or equal to 18 years Suffering from chronic pelvic pain (any pain that lasts more than 6 months and is in the area below the navel to the gluteal fold and causes functional problems for the patient) Presence of at least one painful muscle point in the pelvic area (below the navel to the gluteal fold) Age less than 60 years
Exclusion criteria:
Performing other conservative treatments during the study (oral medicine, manual therapy, physiotherapy, osteopathy, chiropractic, massage) People undergoing chemotherapy or radiotherapy in the pelvic Existence of oncological disease pregnancy pelvic surgery in the last 6 months Suffering from fibromyalgia or chronic fatigue Suffering from serious mental disorders The presence of excessive sensitivity in the skin that may interfere with the treatment process. Suffering from neuromuscular diseases Diabetic people
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization for placement in the control and intervention groups is done using a table of random numbers. The numbers are placed in sealed envelopes and each patient individually chooses one of the envelopes. There is a random sequence in the study and the subjects are unaware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are divided into two groups after entering the study. Both receive biofeedback and the control group receives sham tecar for blinding. He is a physiotherapist who performs biofeedback and monotherapy and knows about the groups. The evaluator or researcher examines and evaluates the patients at the beginning and after 10 sessions, 3 months and 6 months, who is unaware of the control and intervention groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine
Street address
School of Medicine, Iran University of Medical Sciences, Hemmat High way
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.IUMS.FMD.REC.1402.387

Health conditions studied

1

Description of health condition studied
chronic pelvic pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain

Primary outcomes

1

Description
Pain will be checked according to the VAS score. This quantitative and subjective variable includes marking the degree of pain intensity in a straight horizontal line with a constant length of 10 cm. The extremes are defined as extreme limits of a parameter measured from left (worst) to right (best).
Timepoint
The beginning of the study (before the start of the intervention), the end of 10 treatment sessions, 3 and 6 months after the end of the treatment
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Average quality of life score
Timepoint
Before starting the treatment, after 10 treatment sessions, 3 months after the end of the treatment
Method of measurement
Short Form Health (SF-12)

2

Description
Average score of fear of movement
Timepoint
Before starting the treatment, after 10 treatment sessions, 3 months after the end of the treatment
Method of measurement
Tampa Scale of Kinesiophobia (a questionnaire designed to evaluate the fear of movement from different dimensions (belief in injury, avoidance of activity)

Intervention groups

1

Description
Intervention group: They will receive pelvic floor exercises with Surface EMG biofeedback for 10 sessions (up to one and a half months), simultaneously with the biofeedback sessions, the patients will receive 10 therapy sessions with the WINBACK (France) device, a generator that generates 0.5 MHz radio frequency signals with variable power. It emits with a maximum of 300 watts, they will receive 40% capacitive electric transfer for 15 minutes and 40% resistive electric transfer for 10 minutes. In the first visit, the visual analog scale (VAS) was used to measure the intensity of pain, the Short Form 12 Health Questionnaire (SF-12) was used to evaluate the quality of life, and the Tampa Kinesiophobia Scale (TSK-11) was used to evaluate the fear of movement from different dimensions such as belief in Injury, avoidance of activity will be used. Visual analog scale (VAS), health questionnaire short form 12 (SF-12), Tampa scale for Kinesiophobia (TSK-11) will be re-evaluated after 10 sessions (up to one and a half months later) and 3 months later in an in-person session. became. Visual analog scale (VAS) will be re-evaluated after 6 months.
Category
Treatment - Other

2

Description
Control group: They will receive pelvic floor exercises with Surface EMG biofeedback for 10 sessions (up to one and a half months). Also, for the control group, the Tecar probe will be placed on the pain points, but the device will be off (SHAM). In the first visit, the Visual Analogue Scale (VAS) was used to measure pain intensity, the Health Questionnaire Short Form 12 (SF-12) was used to evaluate the quality of life, the Tampa Scale for Kinesiophobia (TSK-11) (to evaluate the fear of movement from different dimensions such as belief in injury, avoidance of activity) will be used. Visual analog scale (VAS), health questionnaire short form 12 (SF-12), Tampa scale for Kinesiophobia (TSK-11) will be re-evaluated after 10 sessions (up to one and a half months later) and 3 months later in an in-person session. became. Visual analog scale (VAS) will be re-evaluated after 6 months.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Dr. Tanaz Ahadi
Street address
Firouzgar Hospital, BehAfrin St, Karimkhan Zand St, Valiasr squarei (Aj), Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۸۷۱۱
Phone
+98 21 8214 1612
Email
tannaz.ahadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, Hemmat high way
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8214 1612
Email
vcr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Physiatrist and professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Froozgar Hospital. Behafarin St, Valiasr sq, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8871 8207
Fax
Email
tannaz.ahadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Physiatrist
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Froozgar Hospital. Behafarin St. Valiasr sq. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8871 8207
Fax
Email
tannaz.ahadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Physiatrist
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Froozgar Hospital. Behafarin St. Valiasr sq.Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8871 8207
Fax
Email
tannaz.ahadi@yahoo.com
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be shared after removing contact name and phone number.
When the data will become available and for how long
Some time after the results are published
To whom data/document is available
Academics and people active in the medical industry can benefit from the information and results.
Under which criteria data/document could be used
Any analysis of study data by academic and research centers is allowed.
From where data/document is obtainable
You can correspond with the scientific officer's email address. tannaz.ahadi@yahoo.com
What processes are involved for a request to access data/document
After receiving the email, the request will be checked and if the corresponding center is approved, the information will be sent.
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