Efficacy of Radiofrequency and the Treatment of Myofascial Pain Syndrome in Postpartum Pelvic Pain: Mixed Research Study
Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
Sponsors
Source
University of Alcala
Oversight Info
Has Dmc
Yes
Is Fda Regulated Device
No
Is Fda Regulated Drug
No
Brief 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. 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.
Overall Status
Recruiting
Start Date
2023-06-27
Completion Date
2025-11-01
Primary Completion Date
2024-10-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain) |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
Sexual function |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
Secondary Outcome
Measure |
Time Frame |
|
Pelvic floor dysfunction symptoms |
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) |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
PFM capacity of relaxation (yes or no) |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
PFM basal tone in grams |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
PFM muscle strength in grams |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
Distance of the urogenital hiatus in milimeters |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
Presence of MPS in PFM and abdominal muscles |
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 |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
|
Self-efficacy |
Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment |
Enrollment
74
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Experimental Group 1
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Experimental Group 2
Eligibility
Criteria
Inclusion Criteria:
- Primiparous women
- Eutocic vaginal birth
- Postpartum pelviperineal pain 8 weeks after birth
- Intensity ≥ 4 cm in the VAS
- Freely signed the Informed consent
Exclusion Criteria:
- 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
- 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.
Gender
Female
Minimum Age
18 Years
Maximum Age
45 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
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. |
Overall Contact
Last Name
Beatriz Navarro-Brazález, PhD
Phone
+34918854828
Phone Ext
4828
b.navarro@uah.es
Location
Facility |
Status |
Contact |
|
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 Spain |
Recruiting |
Last Name: Beatriz Navarro- Brazález, PhD Phone: +34-91-885-48-28 Phone Ext: 4828 Email: b.navarro@uah.es |
Location Countries
Country
Spain
Verification Date
2024-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Alcala
Investigator Full Name
Beatriz Navarro Brazález
Investigator Title
Assistant PhD Professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Experimental Group 1
Arm Group Type
Active Comparator
Description
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.
Arm Group Label
Experimental Group 2
Arm Group Type
Experimental
Description
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.
Firstreceived Results Date
N/A
Acronym
RASDOP
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
December 7, 2023
Study First Submitted Qc
June 17, 2024
Study First Posted
June 21, 2024
Last Update Submitted
June 17, 2024
Last Update Submitted Qc
June 17, 2024
Last Update Posted
June 21, 2024
ClinicalTrials.gov processed this data on December 13, 2024
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.