Clinical trial NCT03175809: Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain
Official title: Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: Chronic pelvic pain
Pain
Dry needling
Biofeedback
Pelvic pain
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The presence of trigger points in the pelvic floor musculature (PFM) is a frequent condition in individuals with chronic pelvic pain (CPP) and is associated with higher levels of pain, disability and functional decline. The purpose of this study is to test the effectiveness of two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with the addition of trigger point dry needling applied over(Lumbar square, psoas, external obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with CPP.

Detailed description: Chronic pelvic pain (CPP) is characterized as non-cyclic pain located in the distal region of the abdomen and pelvis, often refractory to conventional treatments, lasting more than six months The presence of trigger points in the pelvic floor muscles (PFM) is a frequent condition in individuals with CPP and is associated with higher levels of pain, disability and functional decline. Secondary dysfunctions associated with the clinical picture of chronic pelvic pain can be treated with muscle training through the use of biofeedback and dry needling. The purpose of this study is to test the effectiveness of two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with the addition of trigger point dry needling applied over(Lumbar square, psoas, external obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with CPP.

We will recruit 44 women aged 18 to 60 years with CPP lasting for a minimum of six months. We will exclude women with urinary incontinence, neurological conditions, malignancy, fractures, pregnancy and those that did not agree to receive treatment with needles will be excluded.

Individuals will be randomized into two groups: PFM training with biofeedback and Dry Needling Group and PFM training with biofeedback. Participants will receive a total of 4 sessions twice a week,,for two weeks. This investigation's primary outcome will be pain (NRS) Immediately after the 4 visits. Quality of life, global impression of recovery and sexual function evaluated at Immediately after the 4 visits will be secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Women
* Aged between 18 and 60 years
* Pain in the lower pelvic and lumbar region, are not related to filling or emptying of the bladder, for more than 6 months
* With medical diagnosis of CPP

Exclusion Criteria:

* Previous spinal surgery
* Any neurological condition
* Cancer,
* Fractures in the pelvic region and or lumbar spine
* Lumbar radiculopathy.
* Pregnancy
* Women with difficulty in understanding written or spoken language
* Having urinary infection or appendicitis on the day of evaluation,
* Who are diagnosed with Post-coital bleeding, postmenopausal bleeding, unexplained abrupt weight loss, presence of visible mass on ultrasound, macroscopic or microscopic hematuria.
* Performed some surgical intervention with general anesthesia in the last 120 days,
* Having being received Intervesical therapy or botox in the last 90 days,
* Aversion / phobia to needles .

Primary outcomes:
measure: Pelvic Pain
timeFrame: Two weeks after randomization
measure: Pelvic Pain
timeFrame: Four weeks after randomization
Secondary outcomes:
measure: Quality of life of Volunteers
timeFrame: Two weeks after randomization
measure: Satisfaction referred by the volunteers with the treatment
timeFrame: Two weeks after randomization
measure: Sexual dysfunction
timeFrame: Two weeks after randomization
measure: Quality of life of Volunteers
timeFrame: Four weeks after randomization
measure: Satisfaction referred by the volunteers with the treatment
timeFrame: Four weeks after randomization
measure: Sexual dysfunction
timeFrame: Four weeks after randomization
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Mariana D Valentina Pessoa, PT
role: PRINCIPAL_INVESTIGATOR
References: