Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain
Primary Purpose
Chronic Pelvic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PFM training
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring Chronic pelvic pain, Pain, Dry needling, Biofeedback, Pelvic pain
Eligibility 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 .
Sites / Locations
- Universidade Federal de Ciências da Saúde de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PFM training
PFM training plus dry needling
Arm Description
4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback.
PFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points.
Outcomes
Primary Outcome Measures
Pelvic Pain
Numerical Pain rating scale (0-10)
Pelvic Pain
Numerical Pain rating scale (0-10)
Secondary Outcome Measures
Quality of life
SF-12
Satisfaction
self-reported satisfsction with treatment (0-10)
Sexual dysfunction
female sexual dysfunction index (IFSF)
Quality of life
SF-12
Satisfaction
self-reported satisfsction with treatment (0-10)
Sexual dysfunction
female sexual dysfunction index (IFSF)
Full Information
NCT ID
NCT03175809
First Posted
May 13, 2017
Last Updated
July 5, 2017
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03175809
Brief Title
Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain
Official Title
Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
November 23, 2018 (Anticipated)
Study Completion Date
December 25, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain
Keywords
Chronic pelvic pain, Pain, Dry needling, Biofeedback, Pelvic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Single-blinded (outcome assessor)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PFM training
Arm Type
Active Comparator
Arm Description
4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback.
Arm Title
PFM training plus dry needling
Arm Type
Experimental
Arm Description
PFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points.
Intervention Type
Other
Intervention Name(s)
PFM training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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 Measure Information:
Title
Pelvic Pain
Description
Numerical Pain rating scale (0-10)
Time Frame
Two weeks after randomization
Title
Pelvic Pain
Description
Numerical Pain rating scale (0-10)
Time Frame
Four weeks after randomization
Secondary Outcome Measure Information:
Title
Quality of life
Description
SF-12
Time Frame
Two weeks after randomization
Title
Satisfaction
Description
self-reported satisfsction with treatment (0-10)
Time Frame
Two weeks after randomization
Title
Sexual dysfunction
Description
female sexual dysfunction index (IFSF)
Time Frame
Two weeks after randomization
Title
Quality of life
Description
SF-12
Time Frame
Four weeks after randomization
Title
Satisfaction
Description
self-reported satisfsction with treatment (0-10)
Time Frame
Four weeks after randomization
Title
Sexual dysfunction
Description
female sexual dysfunction index (IFSF)
Time Frame
Four weeks after randomization
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo F Silva, Doctor
Phone
55 51 33039000
Ext
8876
Email
marcelofs@ufcspa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana D Valentina Pessoa, PT
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana D Valentina Pessoa, PT
Phone
555191497676
Email
marianadvalentina@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain
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