Clinical trial NCT06506708: Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Endometriosis Patients
Official title: Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Women With Endometriosis Unresponsive to Conventional Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Chronic Pelvic Pain Syndrome
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to analyze the short-term effect of a comprehensive HAMMAM experience combining therapeutic hydrotherapy, aromatherapy, music therapy, and Swedish massage on objective parameters and patient-reported outcomes related to well-being generation and pain reduction in women with endometriosis-related chronic pelvic pain.

Detailed description: The main objective of this project is to analyze the short-term effect of a comprehensive HAMMAM experience combining therapeutic hydrotherapy, aromatherapy, music therapy, and Swedish massage on objective parameters and patient-reported outcomes related to well-being generation and pain reduction in women with endometriosis-related chronic pelvic pain (CPP).

For this purpose, a two-arm pre-post intervention study will be conducted, randomizing 44 women with CPP (22 in the intervention group and 22 in the control group). The intervention group, in addition to following the treatment proposed by their gynecologist, will participate in a comprehensive HAMMAM experience consisting of 3 sessions (one session each 14 days), where they will undergo a 75-minute thermal circuit (cold, warm and hot water pools) and a 15-minute of Swedish massage with a special focus in the abdomino-lumbo-pelvic region. During the last session, massage will be precceded by a 15-min traditional Kessa massage. During kessa massage, women will lie on a hot stone table for 15 minutes, while the skin is covered with red grape soap suds and scrubbed with a cotton fiber glove (kessa). The scrubbing will cleanse the skin of any dirt and residues, which may help them achieve a fully relaxed feeling

As participants in the intervention group, those in the the control group will receive the treatment stipulated by their gynecologist.

Participants will be evaluated before the start of the intervention (t0), and at the end of the last session (t1) on both self-reported variables (subjective well-being scale, satisfaction with life scale, quality of life, pain intensity, pain interference and pain catastrophizing scale), and objective variables (pressure pain thresholds).

Treatment efficacy will be analyzed using ANCOVA through SPSS v24.0 software.

Eligibility criteria: Inclusion Criteria:

* Pelvic pain during the last 6 months more or equal to 4 in a NRS scale.
* Diagnosed with endometriosis (through surgery, magnetic resonance imaging or ultrasound imaging)
* Premenopausal status
* Be able to walk without assistance and to read and write enough
* Be capable and willing to provide consent

Exclusion Criteria:

* Acute or terminal illness
* A recent fracture in any upper or lower extremity (\<3 months), disc herniation and any chronic disease or orthopaedic issues that would interfere with her ability to participate in this intervention program
* Express unwillingness to complete the study requirements
* Be involved in other rehabilitation program

Primary outcomes:
measure: Changes in Pain intensity assessed by NRS
timeFrame: Baseline and immediately after intervention
Secondary outcomes:
measure: Changes in Pain Interference assessed by BPI
timeFrame: Baseline and immediately after intervention
measure: Changes in Pressure pain threshold (PPT) assessed by algometry
timeFrame: Baseline and immediately after intervention
measure: Changes in Catastrophizing thoughts assessed by PCS
timeFrame: Baseline and immediately after intervention
measure: Changes in quality of life assessed by EHP-30
timeFrame: Baseline and immediately after intervention
measure: Changes in functioning assessed by PROMIS-29
timeFrame: Baseline and immediately after intervention
measure: Changes in Subjective well-being assessed by EBS-20
timeFrame: Baseline and immediately after intervention
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Francisco Artacho Cordón
Study officials:
affiliation: Universidad de Granada
name: Francisco Artacho-Cordón
role: PRINCIPAL_INVESTIGATOR
References: