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Clinical Trials/NCT03175809
NCT03175809
Completed
N/A

Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial

Federal University of Health Science of Porto Alegre1 site in 1 country38 target enrollmentJune 9, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pelvic Pain
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
38
Locations
1
Primary Endpoint
Pelvic Pain
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2017
End Date
June 25, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Mariana Della Valentina Pessoa

PT

Federal University of Health Science of Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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,

Outcomes

Primary Outcomes

Pelvic Pain

Time Frame: Four weeks after randomization

Numerical Pain rating scale (0-10)

Secondary Outcomes

  • Sexual dysfunction(Four weeks after randomization)
  • Satisfaction referred by the volunteers with the treatment(Four weeks after randomization)
  • Quality of life of Volunteers(Four weeks after randomization)

Study Sites (1)

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