Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment

Local Injection of Lidocaine Versus Ischemic Compression in Treatment of Woman With Chronic Pelvic Pain Caused by Abdominal Myofascial Pain Syndrome: Randomized Clinical Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Pelvic Pain
• Intervention / Treatment: Drug: lidocaine; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Ribeirão Preto, Sao Paulo, Brazil, 14049-900
      • Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Montenegro ML, Braz CA, Rosa-e-Silva JC, Candido-dos-Reis FJ, Nogueira AA, Poli-Neto OB. Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain. BMC Anesthesiol. 2015 Dec 1;15:175. doi: 10.1186/s12871-015-0155-0.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 25, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): June 6, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: lidocaine; myofascial pain syndrome; ischemic compression; chronic pelvic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes; Pelvic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: HCRP10272/2007