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Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT03175809
Recruitment Status : Unknown
Verified July 2017 by Mariana Della Valentina Pessoa, Federal University of Health Science of Porto Alegre.
Recruitment status was:  Recruiting
First Posted : June 5, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Mariana Della Valentina Pessoa, Federal University of Health Science of Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Chronic Pelvic Pain Other: PFM training Other: Dry needling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Single-blinded (outcome assessor)
Primary Purpose: Treatment
Official Title: Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : November 23, 2018
Estimated Study Completion Date : December 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Active Comparator: PFM training
4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback.
Other: PFM training
The PFM training will be delivered with an electromyographic biofeedback (bEMG). In order to perform the muscular training, the Biotrainer software was used, the training protocol will follow a rationale of evolutionary complexity throughout each session. The training protocols will focus on both muscle relaxation and contraction training and coordination.The parameters for the biofeedback will be tailored to the participant's presentation and will be determined and adjusted between each session as needed by the treating therapist. The treatment parameters will be determined by the treating therapist based on the participant's assessment that will be conducted at each treatment session. The Maximum voluntary contraction will be assessed at the beginning of each training day.

Experimental: PFM training plus dry needling
PFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points.
Other: PFM training
The PFM training will be delivered with an electromyographic biofeedback (bEMG). In order to perform the muscular training, the Biotrainer software was used, the training protocol will follow a rationale of evolutionary complexity throughout each session. The training protocols will focus on both muscle relaxation and contraction training and coordination.The parameters for the biofeedback will be tailored to the participant's presentation and will be determined and adjusted between each session as needed by the treating therapist. The treatment parameters will be determined by the treating therapist based on the participant's assessment that will be conducted at each treatment session. The Maximum voluntary contraction will be assessed at the beginning of each training day.

Other: Dry needling
The dry needling technique will be applied to the abdominal muscles (external oblique, rectus abdominis), lumbar spine (lumbar multifidus and erector spinae) and hip muscles (piriformis, gluteus medius, psoas major and adductors). Both active of latent myofascial trigger points will be treated with sterile stainless steel needles (0.25x0.4 mm or 0.2x0,7mm, DongBang, Korea). After diagnosis of the area of muscle pain, the tight band of the muscle will be palpated and the needle will be introduced subcutaneously. The second insertion will be toward the muscle point until a local twitch response (LTR) is elicited. Then the needle will be removed and the area will be compressed for 30 seconds.




Primary Outcome Measures :
  1. Pelvic Pain [ Time Frame: Two weeks after randomization ]
    Numerical Pain rating scale (0-10)

  2. Pelvic Pain [ Time Frame: Four weeks after randomization ]
    Numerical Pain rating scale (0-10)


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Two weeks after randomization ]
    SF-12

  2. Satisfaction [ Time Frame: Two weeks after randomization ]
    self-reported satisfsction with treatment (0-10)

  3. Sexual dysfunction [ Time Frame: Two weeks after randomization ]
    female sexual dysfunction index (IFSF)

  4. Quality of life [ Time Frame: Four weeks after randomization ]
    SF-12

  5. Satisfaction [ Time Frame: Four weeks after randomization ]
    self-reported satisfsction with treatment (0-10)

  6. Sexual dysfunction [ Time Frame: Four weeks after randomization ]
    female sexual dysfunction index (IFSF)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175809


Contacts
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Contact: Marcelo F Silva, Doctor 55 51 33039000 ext 8876 marcelofs@ufcspa.edu.br

Locations
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Brazil
Universidade Federal de Ciências da Saúde de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90050-170
Contact: Mariana D Valentina Pessoa, PT    555191497676    marianadvalentina@gmail.com   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
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Principal Investigator: Mariana D Valentina Pessoa, PT Federal University of Health Science of Porto Alegre

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Responsible Party: Mariana Della Valentina Pessoa, PT, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03175809     History of Changes
Other Study ID Numbers: FUHSPortoAlegremvp
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariana Della Valentina Pessoa, Federal University of Health Science of Porto Alegre:
Chronic pelvic pain
Pain
Dry needling
Biofeedback
Pelvic pain
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms