Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain (RASDOP)

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.

Study Overview

• Status: Recruiting
• Conditions: To be Approved by the Ethics Committee
• Intervention / Treatment: Other: Active Comparator: Experimental Group 1; Other: Experimental: Experimental Group 2

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Navarro-Brazález, PhD; Phone Number: 4828 +34918854828; Email: b.navarro@uah.es

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28871
      • 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.
      • Contact: Beatriz Navarro- Brazález, PhD; Phone Number: 4828 +34-91-885-48-28; Email: b.navarro@uah.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain)	intensity, behavior and location (pain body chart).	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.	Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor dysfunction symptoms	Presence of urinary, intestinal and/or symptoms suggestive of prolapse	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.	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.	Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM basal tone in grams	Intravaginal dynamometry	Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM muscle strength in grams	Intravaginal dynamometry	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.	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.	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.	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.	Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: Beatriz Navarro-Brazález, PhD, 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Postpartum; Physiotherapy; Pelvic floor; Radiofrequency; Pelvic Pain; Therapeutic adherence; Myofascial Pain Syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Pelvic Pain
• Other Study ID Numbers: 2023/00201/001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No