To be Approved by the Ethics CommitteeRASDOPNCT06469632
Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
A study testing Active Comparator: Experimental Group 1 and Experimental: Experimental Group 2 in people with To be Approved by the Ethics Committee, run by University of Alcala at 1 site in Spain.
Trial summary
About 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. An early physiotherapy treatment could be the solution to the pain relief of these women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- To be Approved by the Ethics Committee
- What is being tested?
- Active Comparator: Experimental Group 1 and Experimental: Experimental Group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jun 2023to Nov 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparous women
- Eutocic vaginal birth
- Postpartum pelviperineal pain 8 weeks after birth
- Intensity ≥ 4 cm in the VAS
- Freely signed the Informed consent
Who cannot join
- Multiparous women
- Instrumental delivery
- Cesarean delivery
- Avulsion of the levator ani muscle
- Diagnosis of coccygodynia and/or coccygeal pain
- Sphincter anal injury during vaginal birth
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- History of pelvic fractures and/or neoplasms
- Pregnant women
- Neurological diseases
- Vaginal infection or active urinary tract, or with any
- Uterine device with metallic components
- Women with cognitive, auditory and/or visual limitations to understand information, respond to questionnaires, consent and/or participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.
Alcalá de Henares, Madrid, 28871
Beatriz Navarro- Brazález, PhD, +34-91-885-48-28 ext. 4828, b.navarro@uah.es
About this study
Official title: Efficacy of Radiofrequency and the Treatment of Myofascial Pain Syndrome in Postpartum Pelvic Pain: Mixed Research Study
About 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. An early physiotherapy treatment could be the solution to the pain relief of these women. Thus, the objectives of the present randomised clinical trail are (i) to determine the effectiveness of a physiotherapy treatment based on education therapeutic, the treatment of myofascial pain syndrome (MPS) of the pelvic floor muscles (PFM), and PFM specific training with or without radiofrequency in reducing pain and improving sexual function; and, (ii) to know the facilitating factors and barriers in adherence and perceived self-efficacy towards physiotherapy treatment of women with pelviperineal pain in the postpartum.
Methodology: randomized clinical trial with examinator blinding and two parallel groups, followed by a qualitative study. Thirty eight women per group will be needed with postpartum pelviperineal pain between 8 weeks after labour, with intensity ≥ 4 cm on the visual analogue scale. The assignment will be random to an Experimental 1 group based on therapeutic education, plus conservative and invasive treatment of MPS and specific PFM exercise versus an Experimental 2 group consisted in the same treatment plus non-ablative radiofrequency treatment. In both cases, 12 individual supervised sessions will be held by a physiotherapist specialized in women's health, with evaluations pre- and post-intervention, at 3 and 6 months. The outcome variables will be the intensity of the pain, the presence of MPS at PFM, the PFM contraction quality, sexual function and specific quality of life. The qualitative study will be carried out in the assessment 6 months post-intervention, through interviews semi-structured and focus groups. The interviews will be guided with previous questions established, recorded, transcribed and thematically analyzed by a panel of experts.
- Conditions
- To be Approved by the Ethics Committee
- Being tested
- Active Comparator: Experimental Group 1, Experimental: Experimental Group 2
- Keywords
- Pelvic Pain, Physiotherapy, Therapeutic adherence, Postpartum, Pelvic floor, Radiofrequency, Myofascial Pain Syndrome
- Medical subject headings
- Pelvic Pain, Treatment Adherence and Compliance, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Experimental Group 1Other
Multimodal physiotherapy treatment composed of:
Therapeutic education about anatomy, physiology and pathophysiology of the abdomino-pelvic cavity, pelvic floor dysfunctions and risk factors, the concept of pain and its associated factors, as well as individual strategies to manage pain.
Specific PFM exercises performing different types of contractions aimed at improving proprioception, strength, resistance and relaxation capacity.
Conservative and invasive treatment of MPS active myofascial trigger points (MTP) will be treated by dry needling and Swiss technique. Latent MTP will be treated using the Swiss technique.
Experimental: Experimental Group 2Other
Multimodal physiotherapy treatment composed of:
Therapeutic education about anatomy, physiology and pathophysiology of the abdomino-pelvic cavity, pelvic floor dysfunctions and risk factors, the concept of pain and its associated factors, as well as individual strategies to manage pain.
Specific PFM exercises performing different types of contractions aimed at improving proprioception, strength, resistance and relaxation capacity.
Conservative and invasive treatment of MPS active myofascial trigger points (MTP) will be treated by dry needling and Swiss technique. Latent MTP will be treated using the Swiss technique.
Non-ablative radiofrequency: using capacitive superficial electrodes and resistive superficial and intravaginal electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Active comparator | There will be 12 individual sessions guided by a physiotherapist specialized in Women's Health. The approximate duration will be 45 minutes/session, 2 times a week for 6 weeks. The intervention will consist of a multimodal physiotherapy treatment based on therapeutic patient education, specific PFM exercises, and conservative and invasive treatment of the MPS. Pre- and post-intervention assessments will be carried out, and at 3 and 6 months after the intervention, by an examining physiotherapist who will be blinding for the intervention group. Receives: Other: Active Comparator: Experimental Group 1 |
| Experimental Group 2 | Experimental | There will be 12 individual sessions guided by a physiotherapist specialized in Women's Health. The approximate duration will be 45 minutes/session, 2 times a week for 6 weeks. The intervention will consist of a multimodal physiotherapy treatment based on therapeutic patient education, specific PFM exercises, conservative and invasive treatment of the MPS and non-ablative radiofrequency. Pre- and post-intervention assessments will be carried out, and at 3 and 6 months after the intervention, by an examining physiotherapist who will be blinding for the intervention group. Receives: Other: Experimental: Experimental Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain)
intensity, behavior and location (pain body chart).
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Sexual function
Self-completion of the FSFI questionnaire, which evaluates sexual function based on 6 domains: desire, excitement, lubrication, orgasm, satisfaction and pain. The maximum score is 36, considering sexual dysfunction a value >27.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Secondary outcomes (9)
Pelvic floor dysfunction symptoms
Presence of urinary, intestinal and/or symptoms suggestive of prolapse
Measured: Pre-treatment, post-treatment (after 12 sessions of physiotherapy treatment which will last approximately 3 months after starting the study), 3 and 6 months after treatment
PFM capacity of contraction through Modified Oxford Scale (0 no contraction, 5 strong contraction)
Intravaginal palpation of pelvic floor muscles with one or two fingers.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM capacity of relaxation (yes or no)
Intravaginal palpation of pelvic floor muscles with one or two fingers.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM basal tone in grams
Intravaginal dynamometry
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM muscle strength in grams
Intravaginal dynamometry
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Distance of the urogenital hiatus in milimeters
Assessment through transperineal ultrasound of the distance of the urogenital hiatus at rest, during a strong PFM contraction and during a pushing effort.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Presence of MPS in PFM and abdominal muscles
Following the diagnostic criteria of Travel and Simons.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Specific quality of life and impact of Pelvoc floor Disfunction using questionnaires: PFDI-20 and PFIQ-7
Through the questionnaires: Pelvic Floor Distress Inventory short version (PFDI-20) and Pelvic Floor Impact Questionnaire short form (PFIQ-7). In both questionnaires, the scores range between 0 and 300, where a higher score indicates more distress and more impact on quality of life.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Self-efficacy
Through Broome Pelvic Muscle Self-Efficacy Scale. The score ranges from 0 to 100, where 100 implies greater self-efficacy.
Measured: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start27 Jun 2023
- Primary completionOct 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To be Approved by the Ethics CommitteeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Navarro Brazález, University of Alcala
- Investigators
- Beatriz Navarro-Brazález, PhD, Principal investigator, Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469632
- Sponsor's protocol ID
- 2023/00201/001
- Other IDs
- 2023
- Acronym
- RASDOP
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency and the Treatment of Myofascial Pain Syndrome in Postpartum Pelvic Pain: Mixed Research Study
- ClinicalTrials.gov ID
- NCT06469632
- Acronym / sponsor ID
- RASDOP / 2023/00201/001
- Conditions
- To be Approved by the Ethics Committee
- Keywords
- Pelvic Pain, Physiotherapy, Therapeutic adherence, Postpartum, Pelvic floor, Radiofrequency, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 21 Jun 2024 (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.
About 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. An early physiotherapy treatment could be the solution to the pain relief of these women. Thus, the objectives of the present randomised clinical trail are (i) to determine the effectiveness of a physiotherapy treatment based on education therapeutic, the treatment of myofascial pain syndrome (MPS) of the pelvic floor muscles (PFM), and PFM specific training with or without radiofrequency in reducing pain and improving sexual function; and, (ii) to know the facilitating factors and barriers in adherence and perceived self-efficacy towards physiotherapy treatment of women with pelviperineal pain in the postpartum.
Methodology: randomized clinical trial with examinator blinding and two parallel groups, followed by a qualitative study. Thirty eight women per group will be needed with postpartum pelviperineal pain between 8 weeks after labour, with intensity ≥ 4 cm on the visual analogue scale. The assignment will be random to an Experimental 1 group based on therapeutic education, plus conservative and invasive treatment of MPS and specific PFM exercise versus an Experimental 2 group consisted in the same treatment plus non-ablative radiofrequency treatment. In both cases, 12 individual supervised sessions will be held by a physiotherapist specialized in women's health, with evaluations pre- and post-intervention, at 3 and 6 months. The outcome variables will be the intensity of the pain, the presence of MPS at PFM, the PFM contraction quality, sexual function and specific quality of life. The qualitative study will be carried out in the assessment 6 months post-intervention, through interviews semi-structured and focus groups. The interviews will be guided with previous questions established, recorded, transcribed and thematically analyzed by a panel of experts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Active comparator | Other: Active Comparator: Experimental Group 1There will be 12 individual sessions guided by a physiotherapist specialized in Women's Health. The approximate duration will be 45 minutes/session, 2 times a week for 6 weeks. The intervention will consist of a multimodal physiotherapy treatment based on therapeutic patient education, specific PFM exercises, and conservative and invasive treatment of the MPS. Pre- and post-intervention assessments will be carried out, and at 3 and 6 months after the intervention, by an examining physiotherapist who will be blinding for the intervention group. |
| Experimental Group 2 | Experimental | Other: Experimental: Experimental Group 2There will be 12 individual sessions guided by a physiotherapist specialized in Women's Health. The approximate duration will be 45 minutes/session, 2 times a week for 6 weeks. The intervention will consist of a multimodal physiotherapy treatment based on therapeutic patient education, specific PFM exercises, conservative and invasive treatment of the MPS and non-ablative radiofrequency. Pre- and post-intervention assessments will be carried out, and at 3 and 6 months after the intervention, by an examining physiotherapist who will be blinding for the intervention group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparous women
- Eutocic vaginal birth
- Postpartum pelviperineal pain 8 weeks after birth
- Intensity ≥ 4 cm in the VAS
- Freely signed the Informed consent
Key exclusion criteria (12 listed)
- Multiparous women
- Instrumental delivery
- Cesarean delivery
- Avulsion of the levator ani muscle
- Diagnosis of coccygodynia and/or coccygeal pain
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 |
|---|---|---|
| Active Comparator: Experimental Group 1Multimodal physiotherapy treatment composed of: Therapeutic education about anatomy, physiology and pathophysiology of the abdomino-pelvic cavity, pelvic floor dysfunctions and risk factors, the concept of pain and its associated factors, as well as individual strategies to manage pain. Specific PFM exercises performing different types of contractions aimed at improving proprioception, strength, resistance and relaxation capacity. Conservative and invasive treatment of MPS active myofascial trigger points (MTP) will be treated by dry needling and Swiss technique. Latent MTP will be treated using the Swiss technique. | Other | Experimental Group 1 |
| Experimental: Experimental Group 2Multimodal physiotherapy treatment composed of: Therapeutic education about anatomy, physiology and pathophysiology of the abdomino-pelvic cavity, pelvic floor dysfunctions and risk factors, the concept of pain and its associated factors, as well as individual strategies to manage pain. Specific PFM exercises performing different types of contractions aimed at improving proprioception, strength, resistance and relaxation capacity. Conservative and invasive treatment of MPS active myofascial trigger points (MTP) will be treated by dry needling and Swiss technique. Latent MTP will be treated using the Swiss technique. Non-ablative radiofrequency: using capacitive superficial electrodes and resistive superficial and intravaginal electrodes. | Other | Experimental Group 2 |
Primary outcome
Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain)
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
intensity, behavior and location (pain body chart).
Sexual function
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Self-completion of the FSFI questionnaire, which evaluates sexual function based on 6 domains: desire, excitement, lubrication, orgasm, satisfaction and pain. The maximum score is 36, considering sexual dysfunction a value >27.
9 secondary outcomes
Pelvic floor dysfunction symptoms
Time frame: Pre-treatment, post-treatment (after 12 sessions of physiotherapy treatment which will last approximately 3 months after starting the study), 3 and 6 months after treatment
PFM capacity of contraction through Modified Oxford Scale (0 no contraction, 5 strong contraction)
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM capacity of relaxation (yes or no)
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM basal tone in grams
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM muscle strength in grams
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Distance of the urogenital hiatus in milimeters
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Presence of MPS in PFM and abdominal muscles
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Specific quality of life and impact of Pelvoc floor Disfunction using questionnaires: PFDI-20 and PFIQ-7
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Self-efficacy
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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.
Beatriz Navarro-Brazález, PhD principal investigator
Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Experimental Group 1 and Experimental: Experimental Group 2 in people with To be Approved by the Ethics Committee, run by University of Alcala at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Navarro-Brazález, PhD (+34918854828 ext. 4828, b.navarro@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain) (time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment). 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 21 Jun 2024.