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Light treatment to relieve pelvic floor pain in women

Photobiomodulation in women with pelvic floor myofascial pain: a feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-44gh2w8
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-01-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor

Interventions

This is a randomized clinical trial (RCT) feasibility study, with blinded evaluator and concealed allocation. A total of 21 women who meet the eligibility criteria will be allocated (allocation ratio
Group 2 (G2): continuous mode, energy of 4 J, at 142.8 J/cm2 per point, total energy of 24 J and irradiation time of 40 seconds per point
Group 3 (G3): continuous mode, energy of 6 J, at 214.2 J/cm per point, total energy of 36 J and irradiation time of 60 seconds per point. The intervention in all groups will last 8 weeks and will be a
E02.594.540

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women with pelvic floor myofascial pain; age 18 and older; women who do not have cognitive dysfunction

Exclusion criteria

Exclusion criteria: Women reporting signs and symptoms of urinary tract infection; History of cancer, pelvic radiotherapy, or brachytherapy; Pregnant women or those trying to conceive; Use of analgesic, narcotic, and muscle relaxant medications; Grade III-IV genital prolapse (according to the Pelvic Organ Prolapse Quantification System (POP-Q)); Patients using photosensitive medications

Design outcomes

Primary

MeasureTime frame
It is expected that when applying Photobiomodulation Therapy with an invisible infrared laser emitter, the patient will have a significant improvement in the reduction of local pain when assessed by the Visual Analogue Pain Scale.

Secondary

MeasureTime frame
It is expected that by applying Photobiomodulation Therapy with an invisible infrared laser emitter, the patient will have an improvement in sexual function, when assessed using the Female Sexual Function Index (FSFI). Data collected one week before the intervention and one week after the intervention.;It is expected that by applying Photobiomodulation Therapy with an invisible infrared laser emitter, the patient will have an improvement in bowel function, which will be assessed using the data collection form and urinary symptoms through the Questionnaire for Urinary Incontinence Diagnosis (QUID). Data collected one week before the intervention and one week after the intervention.;It is expected that by applying Photobiomodulation Therapy with an invisible infrared laser emitter, the patient will have an improvement in pelvic floor symptoms, which will be assessed using the Pelvic Floor Impact Questionnaire (PFIQ-7). Data collected one week before the intervention and one week after the intervention.;It is expected that by applying Photobiomodulation Therapy with an invisible infrared laser emitter, the patient will have an improvement in the function of the pelvic floor muscles assessed using the Modified Oxford scale. Data collected one week before the intervention and one week after the intervention.;It is expected that by applying Photobiomodulation Therapy with an invisible infrared laser emitter, the patient will have an improvement in the tone and relaxation of the pelvic floor muscles, which will be assessed using the International Continence Society (ICS) scale. Data collected one week before the intervention and one week after the intervention.

Countries

Brazil

Contacts

Public ContactAna Virgínia Marques da Costa

Universidade Federal do Ceará

virginiamarques.fisio@gmail.com+55(85)3366-8344

Outcome results

None listed

Source: REBEC (via WHO ICTRP)