Clinical trial NCT05682235: Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Official title: Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Pain
Quality of life
Chronic pelvic pain
therapeutic exercise
pain neurophysiology
physiotherapy
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Through a randomization program, participants will be assigned to the treatment group or the control group.
Primary purpose: TREATMENT

Brief summary: The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to improve pain intensity.

Detailed description: A study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.

Eligibility criteria: Inclusion Criteria:

* Women of reproductive age between 18 and 45 years.
* Women with a medical diagnosis of endometriosis.
* Women with visual analog scale (EVA) between 4 and 10 (moderate-severe pain) during the last 3 months in the suprapubic area, abdomen or perineum both continuously and intermittently.

Exclusion Criteria:

* Women who must have surgery during the study.
* Women who have undergone abdominal or pelvic surgery or who have given birth (vaginal or cesarean) in the last 6 months.
* Women who are pregnant or planning a pregnancy.
* Women with uncorrected pacemakers or coagulopathies, severe comorbid disorder, cancer (in the last 5 years or at present), severe mental disorders, or neuropathies affecting the nerves of the pelvis or lower extremities.
* Physiotherapy treatments or treatments related to pathology or study areas 15 days prior to the beginning of the study.
* Variations in medication in the 3 months prior to the start of the study.

Primary outcomes:
measure: Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
timeFrame: Baseline, Up to 1 month, Up to 3 months
Secondary outcomes:
measure: Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)
timeFrame: Baseline, Up to 1 month, Up to 3 months
measure: Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)
timeFrame: Baseline, Up to 1 month, Up to 3 months
measure: Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: University of Valladolid
Study officials:
affiliation: University of Valladolid
name: Sandra Jímenez, Doctor
role: STUDY_DIRECTOR
affiliation: University Valladolid
name: Luis Ceballos Laita, Doctor
role: STUDY_DIRECTOR
References: