Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain

Chronic Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175809
• Other study ID #: FUHSPortoAlegremvp
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: February 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 25, 2019
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Pain	Numerical Pain rating scale (0-10)	Two weeks after randomization
Primary	Pelvic Pain	Numerical Pain rating scale (0-10)	Four weeks after randomization
Secondary	Quality of life of Volunteers	SF-12	Two weeks after randomization
Secondary	Satisfaction referred by the volunteers with the treatment	self-reported satisfsction with treatment (0-10)	Two weeks after randomization
Secondary	Sexual dysfunction	female sexual dysfunction index (IFSF)	Two weeks after randomization
Secondary	Quality of life of Volunteers	SF-12	Four weeks after randomization
Secondary	Satisfaction referred by the volunteers with the treatment	self-reported satisfsction with treatment (0-10)	Four weeks after randomization
Secondary	Sexual dysfunction	female sexual dysfunction index (IFSF)	Four weeks after randomization