Efficacy of Transcutaneous Electrical Nerve Stimulation (... | NCT06335823

NCT06335823

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active TENS unit	Experimental	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.	Device: Transcutaneous electrical nerve stimulation (TENS)
Non-active TENS unit	Placebo Comparator	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.	Device: Placebo Transcutaneous electrical nerve stimulation (TENS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous electrical nerve stimulation (TENS)	Device	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain During IUD Insertion as Measured by the VAS Score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	IUD placement/introducer removal up to 5 minute

Secondary Outcomes

Measure	Description	Time Frame
Pain During IUD Insertion as Measured by the VAS Score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	speculum placement up to 1 minute
Pain During IUD Insertion as Measured by the VAS Score

Measure	Description	Time Frame
Pain Prior to IUD Insertion as Measured by the VAS Score	The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable	baseline

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jean M Marino, APRN-CNP	University Hospitals	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals		Cleveland	Ohio	44106	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 3, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
BG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00029 BG00131 BG00260

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0006.46± 2.34 OG0015.63± 2.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.2187														Superiority

Secondary

Pain During IUD Insertion as Measured by the VAS Score

The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

VAS data was broken down by cervical block or no cervical block.

Posted

Mean

Standard Deviation

score on a scale

speculum placement up to 1 minute

ID	Title	Description
OG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
OG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.

Secondary

Pain During IUD Insertion as Measured by the VAS Score

The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

VAS data was broken down by cervical block or no cervical block.

Posted

Mean

Standard Deviation

score on a scale

tenaculum placement up to 1 minute

ID	Title	Description
OG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
OG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.

Secondary

Pain During IUD Insertion as Measured by the VAS Score

The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

VAS data was broken down by cervical block or no cervical block

Posted

Mean

Standard Deviation

score on a scale

sound insertion up to 5 minute

ID	Title	Description
OG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
OG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.

Secondary

Pain Post IUD Insertion as Measured by the VAS Score

The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

VAS data broken down by cervical block or no cervical block

Posted

Mean

Standard Deviation

score on a scale

5 minute post IUD insertion

ID	Title	Description
OG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
OG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.

Other Pre-specified

Pain Prior to IUD Insertion as Measured by the VAS Score

The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable

VAS data broken down by Cervical block or no cervical block

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
OG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.	0	26	0	26	0	26
EG001	Non-active TENS Unit	All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.	0	27	0	27	0	27

Title	Organization	Phone	Extension	Email
Jean Marino	University Hospitals Cleveland Medical Center	216-844-8879		jean@kultivatewomenshealth.com

First MCP Posted Date

ID	Term
D004561	Transcutaneous Electric Nerve Stimulation

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation
D000698	Analgesia
D000760	Anesthesia and Analgesia