Local Injection Lidocain and Ischemic Compression in Treatment of Woman With CPP and Abdominal Miofascial Syndrome - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00628355

Purpose

Considering the described facts above, we formulate the hypothesis of that through the comparison of the effectiveness it enters the two main techniques of treatment for woman with secondary chronic pelvic pain the abdominal miofascil syndrome (injection of local anaesthetic and ischemic compression), could be defined more adequate the therapeutical protocol for the treatment of this pathology. We believe that this measure could significantly diminish the expenses with the treatment of chronic pelvic pain, a time the expenditures with medicines, examinations, consultations and the gone repetidasidas ones of these women to the health services would be minimized. Moreover, it will have been evidenced that the two techniques bring similar benefits to the patient, we could adopt the ischemic compression as therapeutical standard for the treatment of these women, a time who this is a cheap therapy, without against indications and of easy learning, being able to be carried through by any professional of the team after study adequate.

Condition	Intervention	Phase
Pelvic Pain	Drug: lidocaine	Phase 0

MedlinePlus related topics: Pelvic Pain

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Local Injection of Lidocaine Versus Ischemic Compression in the Treatment of Woman With Chronic Pelvic Pain Secondary to the Abdominal Miofascial Syndrome: Randomized Clinical Trial.

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

goniometry [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

fleximetry [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lidocaine injection	Drug: lidocaine The blockade of the trigger points will be carried through with two milliliters of lidocaína 0.5% with needle of 22 gauges (black cannon) and 0,70 measures of x 0,25 millimeters, direct and perpendicularly in the point of trigger. After analgesy, the procedure of ischemic compression will be initiated, by means of a pressure supported in the point of trigger, using for this one algômeter, so that if it can get the maximum of homogeneity in the application of the force. The intensity of the applied force will be determined by the average enters the values gotten during three measurements of the threshold of pain of the patient will be carried through three applications with duration of 60 seconds each, with a period of rest of 30 seconds between the applications.
2: Experimental Isquemic compression	Drug: lidocaine The blockade of the trigger points will be carried through with two milliliters of lidocaína 0.5% with needle of 22 gauges (black cannon) and 0,70 measures of x 0,25 millimeters, direct and perpendicularly in the point of trigger. After analgesy, the procedure of ischemic compression will be initiated, by means of a pressure supported in the point of trigger, using for this one algômeter, so that if it can get the maximum of homogeneity in the application of the force. The intensity of the applied force will be determined by the average enters the values gotten during three measurements of the threshold of pain of the patient will be carried through three applications with duration of 60 seconds each, with a period of rest of 30 seconds between the applications.

Arms

Assigned Interventions

1: Experimental

Lidocaine injection

Drug: lidocaine

The blockade of the trigger points will be carried through with two milliliters of lidocaína 0.5% with needle of 22 gauges (black cannon) and 0,70 measures of x 0,25 millimeters, direct and perpendicularly in the point of trigger. After analgesy, the procedure of ischemic compression will be initiated, by means of a pressure supported in the point of trigger, using for this one algômeter, so that if it can get the maximum of homogeneity in the application of the force. The intensity of the applied force will be determined by the average enters the values gotten during three measurements of the threshold of pain of the patient will be carried through three applications with duration of 60 seconds each, with a period of rest of 30 seconds between the applications.

2: Experimental

Isquemic compression

Drug: lidocaine

The blockade of the trigger points will be carried through with two milliliters of lidocaína 0.5% with needle of 22 gauges (black cannon) and 0,70 measures of x 0,25 millimeters, direct and perpendicularly in the point of trigger. After analgesy, the procedure of ischemic compression will be initiated, by means of a pressure supported in the point of trigger, using for this one algômeter, so that if it can get the maximum of homogeneity in the application of the force. The intensity of the applied force will be determined by the average enters the values gotten during three measurements of the threshold of pain of the patient will be carried through three applications with duration of 60 seconds each, with a period of rest of 30 seconds between the applications.

Detailed Description:

After evaluation and disgnostic confirmation, the patients will be randomized and submitted to the treatment with lidocaína injection or ischemic compression. Each treatment will be applied a time per week, in a total of four weeks. Ischemic compression Patient randomized for this protocol, will be submitted to the transcutanea eletroestimulação(TENS), in order to receive analgesy in the region from the trigger point. The analgesia will be carried through by means of electric stimulation in the surface of the skin through electrodes that inhibit the painful stimulatons. The device used for this end will be Dualpex 961, with frequency of 100 HZ, width of pulse of 250ms and intensity varying in accordance with the painful threshold of the patient and the therapy will have duration of thirty 40 minutes. The electrodes will be applied in the region in return of the trigger point, with distance of three cm between itself, in order to close the field of pain. After analgesy, the procedure of ischemic compression will be initiated, by means of a pressure supported in the point of trigger, using for this one algometer, so that if it can get the maximum of homogeneity in the application of the force. The intensity of the applied force will be determined by the average enters the values gotten during three measurements of the threshold of pain of the patient. Three applications with duration of 60 seconds will be carried through each, with a period of rest of 30 seconds between the 33 applications. Blockade anaesthetic: The blockade of the trigger points will be carried through with two milliliters of lidocaína 0.5% with needle of 22 gauges (black cannon) and 0,70 measures of x 0,25 millimeters, direct and perpendicularly in the point of trigger. Evaluations Evaluations in the times will be carried through: - Zero: immediately before the randomized; - One month: immediately after the ending of the four weeks of treatment; - Three months: three months after the treatment; - Six months: six months after the treatment, for cure discarding or improves for effect placebo.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

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

Contacts

Contact: Omero Poli, Doctor

+55-16-36022407

polineto@fmrp.usp.br

Locations

Brazil, Sao Paulo
Abulatory of CPP of Faculty of Medicine of Ribeirao Preto, University of Sao Paulo	Recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Contact: Omero Poli, Doctor +55-16-36022407 polineto@fmrp.usp.br
Principal Investigator: omero Poli, doctor

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Director:

Omero Poli, doctor

University of Sao Paulo

More Information

Responsible Party:	Faculty of Medicine of Ribeirão Preto, University of São Paulo ( Omero Benedicto poli Neto )
Study ID Numbers:	HCRP10272/2007
Study First Received:	February 25, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00628355
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

treatment
chronic pelvic pain

Study placed in the following topic categories:

Signs and Symptoms
Pelvic Pain
Lidocaine

Neoplasm Metastasis
Pain
Ischemia

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009