Hydrotherapy for women with persistent pelvic pain

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: This is a prospective, single blinded pilot randomised controlled trial with concealed allocation, blinded assessors and intention to treat analysis. In addition to usual care, participants allocated to the intervention group will be invited to attend a group‐based, weekly hydrotherapy class for 8 weeks supervised by a Physiotherapist. All hydrotherapy sessions will be a maximum of one hour in duration and will take place within the Physiotherapy Department. The structure of the hydrotherapy sessions will include a warm up, targeted exercises and cool down. Exercises will include but are not limited to walking in water, pelvic floor exercises, pelvic stretches and relaxation, deep water walking, pendular exercises and sea weeding. Session attendance and adherence to the exercises will be monitored by an exercise chart kept in a folder with the Physiotherapist providing the hydrotherapy intervention. This is a different Physiotherapist to that providing usual care. CONDITION: Persistent pelvic pain;Endometriosis; ; Persistent pelvic pain ; Endometriosis Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders PRIMARY OUTCOME: Pain will be assessed by Visual Analogue Scale (VAS). [This measure will be collected by a blinded assessor at baseline and the 8‐week follow‐up ] Pelvic floor function; This outcome will be measured using the Australian Pelvic Floor Questionnaire (APFQ) which is a validated instrument used to record pelvic floor symptoms, in addition to bladder, bowel and sexual function, pelvic organ prolapse and condition specific quality of life[Baseline and at the 8‐week follow‐up; ] Pelvic pain impact; This outcome will be measured using the Pelvic Pain Impact Questionnaire (PPIQ), an instrument used to measure the impact of pelvic pain on quality of life.[ Baseline and at the 8‐week follow‐up] SECONDARY OUTCOME: Acceptability of the programme will be determined using a purpose built questionnaire related to satisfaction with components relevant to the programme. A subset of questions will be identical for both intervention and control groups, with remaining questions relevant to the intervention received. ; ; [8 weeks post baseline] Attendance rates will be assessed by an attendance log kept by the Physiotherapist providing the hydrotherapy. ; [Time point will be at completion of the study. It is anticipated that the trial will take 2 years to complete. ; ] Cost differentials will be assessed by calculating the cost differential between resources used for providing usual care and attendance at group hydrotherapy sessions. Physiotherapy WAUs will be used to calculate labour costs. A record of appointments will come from hospital medical records and hydrotherapy attendance logs. A log will be kept of the parking costs reimbursed to patients. ; ; [Time point will be at completion of the study.] Generic health status using the EQ‐5D‐5L ; ; [Baseline and 8 week follow up] INCLUSION CRITERIA: Inclusion criteria include: ‐ female participants ‐ minimum age 18 years (at the time of study recruitment) ‐ have a formal diagnosis of endometriosis determined by a laparoscopic procedure undertaken at least 6 months prior to study recruitment ‐ referral to the Royal Brisbane and Women's Hospital Physiotherapy Department for management of their persistent pelvic pain condition.
Epistemonikos ID: 45767815b679c1349eb4952a7701bf36149bd993
First added on: Aug 24, 2024