RBR-10kvqs94 Hydrotherapy and perineal massage for chronic pelvic pain due to Endometriosis

Date of registration: 10/27/2025 ^(mm/dd/yyyy)
Last approval date : 10/27/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1327-0275

• Public title:

  en

  Hydrotherapy and perineal massage for chronic pelvic pain due to Endometriosis

  pt-br

  Fisioterapia aquática e massagem perineal para dor pélvica crônica por Endometriose

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 89134925.7.0000.5208
    Issuing authority: Plataforma Brasil
  • 7.757.111
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de Pernambuco

Sponsors

• Primary sponsor: Departamento de Fisioterapia
• Secondary sponsor:
  • Institution: Departamento de Fisioterapia
• Supporting source:
  • Institution: Departamento de Fisioterapia

Health conditions

• Health conditions:

  en

  Endometriosis

  pt-br

  Endometriose

• General descriptors for health conditions:

  en

  C12 Urogenital Diseases

  pt-br

  C12 Doenças Urogenitais

• Specific descriptors:

  en

  C12.050.351.500.163 Endometriosis

  pt-br

  C12.050.351.500.163 Endometriose

Interventions

• Interventions:

  en

  This is a planned, controlled, two-arm, simple-blind clinical trial involving 10 women with endometriosis and chronic pelvic pain, randomly divided into two groups of five participants each: an experimental group and a control group. Recruitment will occur through social media and physician referrals. A history will be taken including sociodemographic, clinical, and anthropometric data, as well as lifestyle habits and pain assessment using the Visual Analog Scale. The Endometriosis Health Profile 30, Female Sexual Function Index, Pelvic Girdle Questionnaire, Multidimensional Fatigue Inventory 10, and Epworth Sleepiness Scale questionnaires will be administered. Pressure pain threshold will be measured with a manual algometer. The assessment will include the gluteus maximus and medius muscles, iliopsoas, multifidus, paravertebral, quadratus lumborum, tensor fasciae latae, and pelvic floor muscles. A Pelvic Floor Sensory and Muscular Function Examination will also be performed. Randomization will be performed by an external statistician in blocks of 5 using opaque, numbered envelopes. Allocation will be confidential and performed only by the intervention team. The patients will be blinded to their group. The experimental group will receive aquatic physiotherapy and perineal massage twice a week for eight weeks, with sixty-minute sessions. The aquatic protocol will include warm-up, stretching, moderate-intensity aerobic exercise using the Revised Borg Scale of Perceived Exertion, and relaxation. At the end of the aquatic sessions, perineal massage will be performed once a week for five minutes. The control group will receive conventional medical treatment with medication. All participants will be reassessed after four and eight weeks of intervention The following questionnaires will be applied: Endometriosis Health Profile-30 (EHP-30): to assess quality of life; Female Sexual Function Index (FSFI): for sexual function; Pelvic Girdle Questionnaire (PGQ): for pelvic girdle dysfunction; Multidimensional Fatigue Inventory (MFI-10): for fatigue; Epworth Sleepiness Scale (ESS): for daytime sleepiness. The pressure pain threshold will be assessed with a Microfet 2 HHD manual algometer (kg/cm²), initially tested on the right hand. The pelvic region will be examined according to the pain in women with endometriosis, including the lower abdomen, perineum and lower back. For the perineum, the point will be between the ischial tuberosity and the coccyx. Other areas assessed include the gluteus maximus and medius, iliopsoas, multifidus, paravertebral, quadratus lumborum and tensor fasciae latae. The threshold will be recorded when the participant says “pain”, with three measurements per point and a 30-second interval. The Pelvic Floor Sensory and Muscular Function Examination (PFME) will be performed by inspection, palpation and manometry, assessing proprioception, pain, tone, reflex, coordination and strength using the Oxford Scale (0 to 5). Women without muscle contraction will not proceed to other stages of the PFME, and missing data will be considered. The perineometer (PelviAir Unit - Miotec) will record the highest pressure of three contractions with a 1-minute interval. The volunteers will be randomized into two groups (experimental or control) following the CONSORT, with a sequence generated by an external statistician via SPSS (version 20.0), using blocks and opaque envelopes. The allocation will be confidential, made only by the intervention team. The evaluators will remain blind to the groups. The experimental group will receive aquatic physiotherapy and perineal massage 2x/week for 8 weeks (60 min each session), according to WHO guidelines (2020) and literature (Cuesta-Vargas et al., 2014). The control group will receive conventional medical treatment. Both will be reassessed after 4 and 8 weeks. Medical treatment consists of hormonal and analgesic medications (Saunders et al., 2021). Aquatic physiotherapy includes: Warm-up: anterior, lateral and posterior walks (1 min each); Stretching: hamstrings, glutes, adductors, abdomen, quadriceps, etc. (2x30s per limb); Aerobic: kicks, abductions, pedaling, etc. (1 min each, moderate intensity, Borg CR10: 3–4); Relaxation: techniques such as hydromassage, floating, and Watsu movements (2 min each). Intensity will be monitored using the Revised Borg Scale (CR10), maintaining a level between 3 and 4 (Scherr et al., 2012). At the end of the aquatic session, perineal massage will be performed once/week (5 min) in a private room, using a two-step technique: External massage: gentle semicircular movements in the vaginal vestibule; Internal massage: sliding and pressure on points of muscle tension, ending with tissue stretching (Álvarez-González et al., 2021; Silva et al., 2016; Montenegro et al., 2010; Oyama et al., 2004).

  pt-br

  Trata-se de um ensaio clínico randomizado controlado de dois braços, simples-cego, com 10 mulheres com endometriose e dor pélvica crônica, divididas aleatoriamente em dois grupos de cinco participantes cada: grupo experimental e grupo controle. O recrutamento ocorrerá por mídias sociais e encaminhamentos médicos. Será realizada anamnese com dados sociodemográficos, clínicos, antropométricos, hábitos de vida e avaliação da dor pela Escala Visual Analógica. Serão aplicados os questionários Endometriosis Health Profile 30, Female Sexual Function Index, Pelvic Girdle Questionnaire, Multidimensional Fatigue Inventory 10 e Epworth Sleepiness Scale. Será medido o limiar de dor à pressão com algômetro manual. A avaliação incluirá músculos glúteo máximo e médio, iliopsoas, multifídio, paravertebral, quadrado lombar e tensor da fáscia lata e assoalho pélvico. Também será realizado o Exame das Funções Sensoriais e Musculares do Assoalho Pélvico. A randomização gerada por estatístico externo, em blocos de 5 e com uso de envelopes opacos e numerados. A alocação será sigilosa e realizada apenas pela equipe de intervenção. As avaliadoras não saberão a que grupo as pacientes pertencem. O grupo experimental receberá fisioterapia aquática e massagem perineal duas vezes por semana durante oito semanas, com sessões de sessenta minutos. O protocolo aquático incluirá aquecimento, alongamento, exercícios aeróbicos com intensidade moderada na Escala de Percepção Subjetiva de Esforço de Borg Revisada e relaxamento. Ao final das sessões aquáticas será realizada massagem perineal uma vez por semana, com duração de cinco minutos. O grupo controle receberá o tratamento médico convencional com uso de medicamentos. Todos os participantes serão reavaliados após quatro e oito semanas de intervenção

• Descriptors:

  en

  E02.190.599.750.750 Massage

  pt-br

  E02.190.599.750.750 Massagem

  en

  E02.779.492 Hydrotherapy

  pt-br

  E02.779.492 Hidroterapia

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 08/12/2025 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	F	18 Y	45 Y

• Inclusion criteria:

  en

  Age range from 18 to 45 years; radiological diagnosis of endometriosis (ultrasound or magnetic resonance imaging) determined by a specialist physician; pelvic pain and dyspareunia score greater than 4 on the Visual Analogue Scale; undergoing conventional medical treatment

  pt-br

  Faixa etária de 18 a 45 anos; Diagnóstico radiológico de endometriose (ultrassom ou ressonância) determinado por médico especialista; pontuação da dor pélvica e dispareunia superior a 4 na Escala Visual Analógica; realizar tratamento médico convencional.

• Exclusion criteria:

  en

  Virginity; pregnancy; postpartum period less than or equal to six months; neurological, rheumatic, or degenerative diseases; history of fracture and/or neoplasm in the spine or pelvis; physical therapy treatment in the last three months; pelvic pain of another nature (such as acute pelvic inflammatory disease, interstitial cystitis, ulcerative colitis, etc.); chlorine allergy; anxiety conditions related to water; severe cardiovascular disease; heat intolerance; active infectious disease; open wounds

  pt-br

  Virgindade; gestação; tempo de pós-parto menor ou igual a seis meses; doenças neurológicas, reumáticas ou degenerativas; Histórico de fratura e/ou neoplasia na coluna vertebral e pelve; tratamento fisioterapêutico nos últimos três meses; dor pélvica de outra natureza (doença inflamatória pélvica aguda, cistite intersticial, retocolite e etc.); alergia ao cloro; condições de ansiedade relacionadas à água; doença cardiovascular grave; intolerância ao calor; doença infecciosa ativa; feridas abertas

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  It is expected to observe a reduction in the intensity of pelvic pain

  pt-br

  Espera-se observar a redução da intensidade da dor pélvica

• Secondary outcomes:

  en

  It is expected to improve Quality of Life, Sexual Function, Sensory and Muscular Functions of the Pelvic Floor, Functionality of the Pelvic Girdle and Fatigue and it aims to reduce the Pressure Pain Threshold and Daytime Sleepiness

  pt-br

  Espera-se melhorar a Qualidade de vida, a Função sexual, as Funções sensoriais e musculares do assoalho pélvico, a Funcionalidade da cintura pélvica e a Fadiga e visa-se diminuir o Limiar de dor à pressão e a Sonolência diurna

Contacts

• Public contact
  • Full name: Joyce Pereira da Silva
  • • Address: Av. Jorn. Aníbal Fernandes, 173 - Cidade Universitária, Recife - PE, 50740-560
    • City: Recife / Brazil
    • Zip code: 50740-560
  • Phone: +55(81)99741-4372
  • Email: joyce.psilva@ufpe.br
  • Affiliation: Universidade Federal de Pernambuco
   
• Scientific contact
  • Full name: Joyce Pereira da Silva
  • • Address: Av. Jorn. Aníbal Fernandes, 173 - Cidade Universitária, Recife - PE, 50740-560
    • City: Recife / Brazil
    • Zip code: 50740-560
  • Phone: +55(81)99741-4372
  • Email: joyce.psilva@ufpe.br
  • Affiliation: Universidade Federal de Pernambuco
  • Full name: Caroline Wanderley Souto Ferreira
  • • Address: Av. Jorn. Aníbal Fernandes, 173 - Cidade Universitária
    • City: Recife / Brazil
    • Zip code: 50740-560
  • Phone: +55(81)99999-0060
  • Email: caroline.wanderley@ufpe.br
  • Affiliation: Universidade Federal de Pernambuco
   
• Site contact
   

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