Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain

Sponsor

Federal University of Health Science of Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT03175809

Collaborator

(none)

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized 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 :

Jun 9, 2017

Anticipated Primary Completion Date :

Nov 23, 2018

Anticipated Study Completion Date :

Dec 25, 2018

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Pelvic Pain [Two weeks after randomization]
Numerical Pain rating scale (0-10)
Pelvic Pain [Four weeks after randomization]
Numerical Pain rating scale (0-10)

Secondary Outcome Measures

Quality of life [Two weeks after randomization]
SF-12
Satisfaction [Two weeks after randomization]
self-reported satisfsction with treatment (0-10)
Sexual dysfunction [Two weeks after randomization]
female sexual dysfunction index (IFSF)
Quality of life [Four weeks after randomization]
SF-12
Satisfaction [Four weeks after randomization]
self-reported satisfsction with treatment (0-10)
Sexual dysfunction [Four weeks after randomization]
female sexual dysfunction index (IFSF)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 .