Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain

NCT ID: NCT06469632

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2025-11-30

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.

Conditions

To be Approved by the Ethics Committee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group 1

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.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Experimental Group 1

Intervention Type: OTHER

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 Group 2

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.

Group Type: EXPERIMENTAL

Experimental: Experimental Group 2

Intervention Type: OTHER

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.

Interventions

Active Comparator: Experimental Group 1

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.

Intervention Type: OTHER

Experimental: Experimental Group 2

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Beatriz Navarro Brazález

Assistant PhD Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beatriz Navarro-Brazález, PhD

Role: 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.

Locations

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, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Beatriz Navarro-Brazález, PhD

Role: CONTACT

b.navarro@uah.es

+34918854828 ext. 4828

Facility Contacts

Beatriz Navarro- Brazález, PhD

Role: primary

b.navarro@uah.es

+34-91-885-48-28 ext. 4828

Other Identifiers

2023/00201/001

Identifier Type: -

Identifier Source: org_study_id