Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment

NCT00628355 | Terminated Phase 4 Results DMC

• 1 other identifier: HCRP10272/2007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain

Keywords

lidocaine; ischemic compression; chronic pelvic pain; myofascial pain syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

lidocaine injection

EXPERIMENTAL

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

Ischemic compression

EXPERIMENTAL

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

Interventions

lidocaine DRUG

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

Also known as: Lidocaine injection

lidocaine injection

Ischemic compression PROCEDURE

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.

Ischemic compression

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with chronic diagnosis of pelvic pain;
• Women in menacme;
• Presence of the diagnostic criteria for abdominal myofascial syndrome;
• Agreement with the Term of Free and Clarified Assent.

You may not qualify if:

• Endometriosis, interstitial cystitis, syndrome of the irritable intestine or another illness that it justifies or it contributes for chronic pelvic pain;
• Endometrioma or hernia evidenced to the ultrasound of the abdominal wall.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26628263 DERIVED

MeSH Terms

Conditions

Pelvic Pain; Myofascial Pain Syndromes

Interventions

Lidocaine; Acupressure

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Omero Benedicto Poli Neto
• Organization: Ribeirao Preto Medical School - University of Sao Paulo

polineto@fmrp.usp.br

551636023183

Study Officials

• Omero Poli, doctor

  University of Sao Paulo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 6, 2014
• Results First Posted: April 25, 2014

Record last verified: 2014-05

Locations

BR (1)