Pelvic Pain
Conditions
Keywords
lidocaine, ischemic compression, chronic pelvic pain, myofascial pain syndrome
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.
Interventions
DRUGlidocaine
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
PROCEDUREIschemic 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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Pain | immediately, 1, 3 months after treatment | 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. |
| Clinical Response Rate | immediately, 1, 3 months after treatment | We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement. |
Countries
Brazil
Participant flow
Recruitment details
All subjects were recruited at Center of Chronic Pelvic Pain at Hospital das Clinicas of Ribeirão Preto Medical School, during 2010. The study was early stopped because the comparator (lidocaine injection) appears significantly more effective.
Participants by arm
| Arm | Count |
|---|---|
| Ischemic Compression Group received TENS plus Ischemic compression | 14 |
| Anesthesia Injection group received lidocaine injections once a week for 4 weeks | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Ischemic Compression | Anesthesia Injection |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 14 Participants | 14 Participants |
| Age, Continuous | 37.6 years STANDARD_DEVIATION 3.1 | 36.8 years STANDARD_DEVIATION 3.2 | 38.5 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment Brazil | 28 participants | 14 participants | 14 participants |
| Sex: Female, Male Female | 28 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Clinical Response Rate
We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.
Time frame: immediately, 1, 3 months after treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ischemic Compression | Clinical Response Rate | immediately after treatment | 17.5 percentage of participants |
| Ischemic Compression | Clinical Response Rate | 1 month after treatment | 8.8 percentage of participants |
| Ischemic Compression | Clinical Response Rate | 3 months after treatment | 7.0 percentage of participants |
| Anesthesia Injection | Clinical Response Rate | immediately after treatment | 45.3 percentage of participants |
| Anesthesia Injection | Clinical Response Rate | 1 month after treatment | 60.2 percentage of participants |
| Anesthesia Injection | Clinical Response Rate | 3 months after treatment | 69.9 percentage of participants |
Primary
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.
Time frame: immediately, 1, 3 months after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ischemic Compression | Intensity of Pain | immediately after treatment | 52.7 millimeters | Standard Deviation 22.2 |
| Ischemic Compression | Intensity of Pain | 1 month after treatment | 53.0 millimeters | Standard Deviation 17.4 |
| Ischemic Compression | Intensity of Pain | 3 months after treatment | 50.8 millimeters | Standard Deviation 24.4 |
| Anesthesia Injection | Intensity of Pain | immediately after treatment | 33.7 millimeters | Standard Deviation 29.2 |
| Anesthesia Injection | Intensity of Pain | 1 month after treatment | 27.1 millimeters | Standard Deviation 33.4 |
| Anesthesia Injection | Intensity of Pain | 3 months after treatment | 20.8 millimeters | Standard Deviation 26 |