Local Injection Lidocain and Ischemic Compression in Treatment of Woman With CPP and Abdominal Miofascial Syndrome
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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. |
- goniometry [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- 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 |
|---|---|
|
Experimental: 1
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.
Other Names:
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|
Experimental: 2
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.
Other Names:
|
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 |
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| Contact: Omero Poli, Doctor | +55-16-36022407 | polineto@fmrp.usp.br |
| Brazil | |
| 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 | |
| Study Director: | Omero Poli, doctor | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Omero Benedicto poli Neto, Faculty of Medicine of Ribeirão Preto, University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT00628355 History of Changes |
| Other Study ID Numbers: | HCRP10272/2007 |
| Study First Received: | February 25, 2008 |
| Last Updated: | February 25, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
treatment chronic pelvic pain |
Additional relevant MeSH terms:
|
Pelvic Pain Pain Signs and Symptoms Lidocaine 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 |
ClinicalTrials.gov processed this record on May 21, 2013