Trial Outcomes & Findings for Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment (NCT NCT00628355)

Results Overview

The pain will measured by using the visual analogue scale, that is represented by a straight line of 100mm starting at "absence of pain" and ending at point "worst pain experienced or imagined".

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

immediately, 1, 3 months after treatment

Results posted on

2014-06-06

Participant Flow

All subjects were recruited at Center of Chronic Pelvic Pain at Hospital das Clinicas of Ribeirão Preto Medical School, during 2010. The study was early stopped because the comparator (lidocaine injection) appears significantly more effective.

Participant milestones

Participant milestones
Measure	TENS Plus Ischemic Compression Group received TENS plus ischemic compression	Anesthesia Injection Group received lidocaine injection
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TENS Plus Ischemic Compression Group received TENS plus ischemic compression	Anesthesia Injection Group received lidocaine injection
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ischemic Compression n=14 Participants Group received TENS plus Ischemic compression	Anesthesia Injection n=14 Participants group received lidocaine injections once a week for 4 weeks	Total n=28 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 3.2 • n=93 Participants	38.5 years STANDARD_DEVIATION 2.8 • n=4 Participants	37.6 years STANDARD_DEVIATION 3.1 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Brazil	14 participants n=93 Participants	14 participants n=4 Participants	28 participants n=27 Participants

PRIMARY outcome

Timeframe: immediately, 1, 3 months after treatment

The pain will measured by using the visual analogue scale, that is represented by a straight line of 100mm starting at "absence of pain" and ending at point "worst pain experienced or imagined".

Outcome measures

Outcome measures
Measure	Ischemic Compression n=14 Participants Group received ischemic compression	Anesthesia Injection n=14 Participants Group received lidocaine injection
Intensity of Pain immediately after treatment	52.7 millimeters Standard Deviation 22.2	33.7 millimeters Standard Deviation 29.2
Intensity of Pain 1 month after treatment	53.0 millimeters Standard Deviation 17.4	27.1 millimeters Standard Deviation 33.4
Intensity of Pain 3 months after treatment	50.8 millimeters Standard Deviation 24.4	20.8 millimeters Standard Deviation 26.0

PRIMARY outcome

Timeframe: immediately, 1, 3 months after treatment

We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.

Outcome measures

Outcome measures
Measure	Ischemic Compression n=14 Participants Group received ischemic compression	Anesthesia Injection n=14 Participants Group received lidocaine injection
Clinical Response Rate immediately after treatment	17.5 percentage of participants	45.3 percentage of participants
Clinical Response Rate 1 month after treatment	8.8 percentage of participants	60.2 percentage of participants
Clinical Response Rate 3 months after treatment	7.0 percentage of participants	69.9 percentage of participants

Adverse Events

Ischemic Compression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anesthesia Injection

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ischemic Compression n=15 participants at risk Group received Ischemic compression	Anesthesia Injection n=15 participants at risk group received lidocaine injections once a week for 4 weeks
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/15 Periodic medical visits and phone calls.	13.3% 2/15 • Number of events 2 Periodic medical visits and phone calls.

Additional Information

Omero Benedicto Poli Neto

Ribeirao Preto Medical School - University of Sao Paulo

Phone: 551636023183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place