Chronic Pelvic PainNCT03175809
Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain
A study testing PFM training and Dry needling in people with Chronic Pelvic Pain, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- PFM training and Dry needling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Jun 2017to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Previous spinal surgery
- Any neurological condition
- Cancer,
- Fractures in the pelvic region and or lumbar spine
- Lumbar radiculopathy.
- Pregnancy
Show all 12Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Pelvic Pain
- Being tested
- PFM training, Dry needling
- Keywords
- Chronic pelvic pain, Pain, Dry needling, Biofeedback, Pelvic pain
- Medical subject headings
- Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFM trainingOther
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 needlingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PFM training | Active comparator | 4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback. Receives: 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. Receives: Other: PFM training; Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Pain
Numerical Pain rating scale (0-10)
Measured: Two weeks after randomization
Pelvic Pain
Numerical Pain rating scale (0-10)
Measured: Four weeks after randomization
Secondary outcomes (6)
Quality of life of Volunteers
SF-12
Measured: Two weeks after randomization
Satisfaction referred by the volunteers with the treatment
self-reported satisfsction with treatment (0-10)
Measured: Two weeks after randomization
Sexual dysfunction
female sexual dysfunction index (IFSF)
Measured: Two weeks after randomization
Quality of life of Volunteers
SF-12
Measured: Four weeks after randomization
Satisfaction referred by the volunteers with the treatment
self-reported satisfsction with treatment (0-10)
Measured: Four weeks after randomization
Sexual dysfunction
female sexual dysfunction index (IFSF)
Measured: Four weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start9 Jun 2017
- Primary completion23 Nov 2018
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Della Valentina Pessoa, Federal University of Health Science of Porto Alegre
- Investigators
- Mariana D Valentina Pessoa, PT, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175809
- Sponsor's protocol ID
- FUHSPortoAlegremvp
- Status last verified
- Feb 2024
- First submitted
- 13 May 2017
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Training With or Without Dry Needling for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03175809
- Acronym / sponsor ID
- FUHSPortoAlegremvp
- Conditions
- Chronic Pelvic Pain
- Keywords
- Chronic pelvic pain, Pain, Dry needling, Biofeedback, Pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| PFM training | Active comparator | Other: PFM training4 sessions (40 minutes approximately), Twice a week for 2 weeks of pelvic floor training with electromyographic biofeedback. |
| PFM training plus dry needling | Experimental | Other: PFM training, Other: Dry needlingPFM training associated with the use of dry needling over abdominal, gluteal and lombar miofascial trigger points. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Previous spinal surgery
- Any neurological condition
- Cancer,
- Fractures in the pelvic region and or lumbar spine
- Lumbar radiculopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFM trainingThe 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 | PFM training, PFM training plus dry needling |
| Dry needlingThe 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. | Other | PFM training plus dry needling |
Primary outcome
Pelvic Pain
Time frame: Two weeks after randomization
Numerical Pain rating scale (0-10)
Pelvic Pain
Time frame: Four weeks after randomization
Numerical Pain rating scale (0-10)
6 secondary outcomes
Quality of life of Volunteers
Time frame: Two weeks after randomization
Satisfaction referred by the volunteers with the treatment
Time frame: Two weeks after randomization
Sexual dysfunction
Time frame: Two weeks after randomization
Quality of life of Volunteers
Time frame: Four weeks after randomization
Satisfaction referred by the volunteers with the treatment
Time frame: Four weeks after randomization
Sexual dysfunction
Time frame: Four weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana D Valentina Pessoa, PT principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFM training and Dry needling in people with Chronic Pelvic Pain, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Pain (time frame: Two weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.