Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00628355
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 24.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Our hypothesis is that with comparison of effectiveness of two most common techniques of treatment for myofascial pain syndrome (injection of local anesthesia and ischemic compression) we could choice the most adequate to treat this disease. This way we could decrease the expenses with medicines, examinations, consultations and the time that women remains without a diagnosis and treatment.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain	Drug: lidocaine; Procedure: Ischemic compression	Phase 4

Detailed Description

After evaluation and diagnostic confirmation, the patients will be randomized and submitted to the treatment with lidocaine injection or ischemic compression. Each treatment will be placed once a week, for four weeks. Women randomized for treatment with Ischemic compression, will be first subjected to transcutaneal electrostimulation(TENS), in order to receive analgesia on trigger point. The analgesia will be used to inhibit the painful stimulation. The device used for this will be the Dualpex 961, with 100 Hertz of frequency and pulse of 250ms. The intensity will be vary according the painful threshold of each patient. The electrostimulation will be made for 30 minutes. The electrodes will be applied around the trigger point. After analgesia, the ischemic compression will be applied. This therapy consists in a continuous pressure on trigger point. For this we will use one algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. This therapy will be applied three times with duration of 60 seconds each with a 30 seconds of rest between the applications. Injection of anesthesia: this therapy will be applied directly in trigger points with two mL of lidocaine 0.5% with needle of 22 gauges directly and perpendicularly in trigger point. The Evaluations for each treatment will be carried immediately before the randomization; In one month: immediately after the four weeks of treatment; - Three months: three months after the treatment; - Six months: six months after the treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Local Injection of Lidocaine Versus Ischemic Compression in Treatment of Woman With Chronic Pelvic Pain Caused by Abdominal Myofascial Pain Syndrome: Randomized Clinical Trial.
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lidocaine injection Lidocaine injection. Women randomized for this treatment was submitted to 2 milliliters of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks	Drug: lidocaine; Women randomized for this treatment was submitted to 2mL of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks; Other Names: Lidocaine injection
Experimental: Ischemic compression Women randomized for treatment with ischemic compression will be first subjected to transcutaneal electrostimulation (TENS) for 30 minutes on trigger point to inhibit the painful stimulation. For this will be used 100 Hertz of frequency and pulse of 250ms. The intensity will be varying according the painful threshold of each patient. After, the ischemic compression will be applied. For this we will use an algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. The therapy will be applied in trigger point three times (60 seconds each) with 30 seconds of rest between the applications.	Procedure: Ischemic compression; Women randomized for treatment with ischemic compression will be first subjected to transcutaneal electrostimulation(TENS) for 30 minutes on trigger point to inhibit the painful stimulation. For this will be used 100 Hertz of frequency and pulse of 250ms. The intensity will be varying according the painful threshold of each patient. After, the ischemic compression will be applied. For this we will use an algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. The therapy will be applied in trigger point three times (60 seconds each) with 30 seconds of rest between the applications.

Outcome Measures

Primary Outcome Measures

1. Intensity of Pain [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".

2. Clinical Response Rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women with chronic diagnosis of pelvic pain;

2. Women in menacme;

3. Presence of the diagnostic criteria for abdominal myofascial syndrome;

4. Agreement with the Term of Free and Clarified Assent.

Exclusion Criteria:

1. Endometriosis, interstitial cystitis, syndrome of the irritable intestine or another illness that it justifies or it contributes for chronic pelvic pain;

2. Endometrioma or hernia evidenced to the ultrasound of the abdominal wall.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo	Ribeirão Preto	Sao Paulo	Brazil	14049-900

Sponsors and Collaborators

• University of Sao Paulo

Investigators

• Study Director: Omero Poli, doctor, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omero Benedicto Poli Neto, Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT00628355
• Other Study ID Numbers: HCRP10272/2007
• First Posted: Mar 5, 2008
• Last Update Posted: Jun 6, 2014
• Last Verified: May 1, 2014

• Keywords provided by Omero Benedicto Poli Neto, Professor, University of Sao Paulo: lidocaine; ischemic compression; chronic pelvic pain; myofascial pain syndrome
• Additional relevant MeSH terms: Myofascial Pain Syndromes; Pelvic Pain; Lidocaine

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	TENS Plus Ischemic Compression	Anesthesia Injection
Arm/Group Description	Group received TENS plus ischemic compression	Group received lidocaine injection
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	14
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ischemic Compression	Anesthesia Injection	Total
Arm/Group Description	Group received TENS plus Ischemic compression	group received lidocaine injections once a week for 4 weeks	Total of all reporting groups
Overall Participants	14	14	28
Age (Count of Participants)
Between 18 and 65 years	14 100%	14 100%	28 100%
>=65 years	0 0%	0 0%	0 0%
<=18 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.8 (3.2)	38.5 (2.8)	37.6 (3.1)
Sex: Female, Male (Count of Participants)
Female	14 100%	14 100%	28 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Brazil	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Intensity of Pain
Description	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".
Time Frame	immediately, 1, 3 months after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ischemic Compression	Anesthesia Injection
Arm/Group Description	Group received ischemic compression	Group received lidocaine injection
Measure Participants	14	14
immediately after treatment	52.7 (22.2)	33.7 (29.2)
1 month after treatment	53.0 (17.4)	27.1 (33.4)
3 months after treatment	50.8 (24.4)	20.8 (26.0)

2. Primary Outcome

Title	Clinical Response Rate
Description	We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.
Time Frame	immediately, 1, 3 months after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TENS Plus Ischemic Compression	Anesthesia Injection
Arm/Group Description	Group received TENS plus ischemic compression	Group received lidocaine injection
Measure Participants	14	14
immediately after treatment	17.5 125%	45.3 323.6%
1 month after treatment	8.8 62.9%	60.2 430%
3 months after treatment	7.0 50%	69.9 499.3%

Adverse Events

Adverse Event Reporting Description	Periodic medical visits and phone calls.
Arm/Group Title	Ischemic Compression		Anesthesia Injection
Arm/Group Description	Group received Ischemic compression		group received lidocaine injections once a week for 4 weeks
All Cause Mortality
	Ischemic Compression		Anesthesia Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ischemic Compression		Anesthesia Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Ischemic Compression		Anesthesia Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		2/15 (13.3%)
Skin and subcutaneous tissue disorders
Ecchymosis	0/15 (0%)	0	2/15 (13.3%)	2

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.