Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain

NCT03175809 | Completed DMC

• 1 other identifier: FUHSPortoAlegremvp
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain

Keywords

Chronic pelvic pain; Pain; Dry needling; Biofeedback; Pelvic pain

Outcome Measures

Primary Outcomes (2)

• Pelvic Pain

  Numerical Pain rating scale (0-10)

  Two weeks after randomization

• Pelvic Pain

  Numerical Pain rating scale (0-10)

  Four weeks after randomization

Secondary Outcomes (6)

• Quality of life of Volunteers

  Two weeks after randomization

• Satisfaction referred by the volunteers with the treatment

  Two weeks after randomization

• Sexual dysfunction

  Two weeks after randomization

• Quality of life of Volunteers

  Four weeks after randomization

• Satisfaction referred by the volunteers with the treatment

  Four weeks after randomization

Study Arms (2)

PFM training

ACTIVE COMPARATOR

4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback.

Other: PFM training

PFM training plus dry needling

EXPERIMENTAL

PFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points.

Other: PFM training; Other: Dry needling

Interventions

PFM training OTHER

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.

PFM training; PFM training plus dry needling

Dry needling OTHER

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.

PFM training plus dry needling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Pain; Pelvic Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Mariana D Valentina Pessoa, PT

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blinded (outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 13, 2017
• First Posted: June 5, 2017
• Study Start: June 9, 2017
• Primary Completion: November 23, 2018
• Study Completion: June 25, 2019
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)