Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment

This study has been terminated.
(Lidocaine injection group showed significant improvement in pain)
Sponsor:
Information provided by (Responsible Party):
Omero Benedicto Poli Neto, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00628355
First received: February 25, 2008
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Pelvic Pain
Drug: lidocaine
Procedure: Ischemic compression
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intensity of Pain [ Time Frame: immediately, 1, 3 months after treatment ] [ Designated as safety issue: Yes ]
    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".

  • Clinical Response Rate [ Time Frame: immediately, 1, 3 months after treatment ] [ Designated as safety issue: Yes ]
    We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.


Enrollment: 30
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: Ischemic compression

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628355

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Omero Benedicto Poli Neto, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00628355     History of Changes
Other Study ID Numbers: HCRP10272/2007
Study First Received: February 25, 2008
Results First Received: September 15, 2010
Last Updated: May 23, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
lidocaine
ischemic compression
chronic pelvic pain
myofascial pain syndrome

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Pelvic Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Signs and Symptoms
Lidocaine
Vasoconstrictor Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014