Clinical trial NCT00628355: Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pelvic Pain
Keywords: lidocaine
ischemic compression
chronic pelvic pain
myofascial pain syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Intensity of Pain
timeFrame: immediately, 1, 3 months after treatment
measure: Clinical Response Rate
timeFrame: immediately, 1, 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Omero Poli, doctor
role: STUDY_DIRECTOR
References:
citation: 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.