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NCT Number: NCT06209346

Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis

* Objective: To determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the Visual Numerical Scale (EVN), catastrophizing with the Pain Catastrophizing Scale (PCS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), improves sexual function according to the Female Sexual Function Index (FSFI) and QoL compared to the Control Group with the Health Status Questionnaire (SF-12). * Follow-up: four evaluated questionnaires: preintervention; postintervention, 3 months postintervention, 6 months postintervention * Participants: 66 women diagnosed with endometriosis with chronic pelvic pain in different Spanish endometriosis associations. * Randomization: women will be randomly assigned to two groups using the EpiData 3.1 software * Interventions: Experimental Group: therapeutic exercise + conscious breathing (16 sessions) and pain education (4 sessions) through the TRAK platform.

Control Group: They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease.

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Key information

Conditions

Endometriosis Chronic Pelvic Pain Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy in women´s health research group. University of Alcalà

Alcalà de Henares, Madrid, 28871, Spain

Location status: Recruiting

Location contact

María Torres-Lacomba, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with a medical diagnosis of endometriosis.
  • Age equal to or older than 18 years and up to 55 years.
  • Who are or have received medical and/or surgical treatment and with controlled disease.
  • Persistent pelvic pain for at least 3 months.
  • Pain greater than 4 on the EVN.
  • No cognitive limitation to understand the information sheet, instructions and freely sign the informed consent
  • Have any electronic device available (tablet, computer, cell phone).
  • Have a current email address.
  • Have a valid e-mail address.

Exclusion criteria

  • Peri- and postmenopausal women.
  • Women pregnant or desiring gestation during the study.
  • Women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region
  • Women with a diagnosis of chronic fatigue or fibromyalgia▪.
  • Women concomitantly participating in another intervention study.
  • Women undergoing surgery during the study.

Treatment and study plan

TeleRehab Group

Other

The duration of treatment for the Experimental Group will be 8 weeks and will consist of a total of 20 sessions, with between 2 and 3 sessions per week depending on the week they are in.

Weeks 2, 4, 6 and 8 will have 2 sessions per week and weeks 1, 3, 5 and 7 will have 3 sessions per week.

These sessions will consist of videos that will make up the educational material, videos that will guide the ET program and respiratory control practices.All the sessions mentioned above will be in online format, through the TRAK platform.

Other names: TrhbG

Advices Group

Other

They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease. Participants in the Control Group will have the same follow-up evaluations as the Experimental Group and will receive informative material. They will not have access to the audiovisual material generated for the Experimental Group.

Other names: AG

Primary outcomes

  1. Health Status Questionnaire (SF-12)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means poorer health and a score of 100 means better health.

    Change from baseline in quality of life at two month (post-intervention); and 3 and 5 months post-intervention

  2. Visual Numeric Scale (VNS)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means no pain, 1 to 3 means mild pain, 4 to 6 means moderate pain and 7 to 10 means severe pain.

    Change from baseline in pain at two month (post-intervention); and 3 and 5 months post-intervention

  3. Endometriosis Health Profile (EHP-30)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 indicates the best health status to the worst health status of 100.

    Change from baseline in endometriosis affectation at two month (post-intervention); and 3 and 5 months post-intervention

  4. Index of Sexual Function (IFSF)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The final score (total score: minimum 2 and maximum 36). The higher the better sexual function, the lower the worse sexual function.

    Change from baseline in sexual function at two month (post-intervention); and 3 and 5 months post-intervention

  5. Tampa Scale of Kinesiophobia (TSK)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The lowest possible score, 11, no kinesiophobia. The highest possible score, 44, denotes a severe kinesophobia

    Change from baseline in kinesiophobia at two month (post-intervention); and 3 and 5 months post-intervention

  6. Pain Catastrophizing Scale (PCS)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing.

    Change from baseline in catastrophixing at two month (post-intervention); and 3 and 5 months post-intervention

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score ranges from 0 to 21 points. Normal range (0-7), Possible A/D (8-10) and Case A/D

    Change from baseline in anxiety and depression at two month (post-intervention); and 3 and 5 months post-intervention

  2. International Physical Activity Questionnaire (IPAQ)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. Low: low physical activity Medium: 3+days of vigorous physical activity.High:performs vigorous physical activity reaching a high energy

    Change from baseline in physical activity at two month (post-intervention); and 3 and 5 months post-intervention

  3. Pittsburg Sleep Quality Index (PSQI)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score ranges from 0 (no difficulty) to 21 (difficulties in all areas).

    Change from baseline in sleep quality at two month (post-intervention); and 3 and 5 months post-intervention

  4. Perceived Stress Scale (PSS)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The score ranges from 0 to 56 and indicates that a higher score corresponds to a higher level of perceived stress.

    Change from baseline in stress at two month (post-intervention); and 3 and 5 months post-intervention

  5. Patient's adherence will be evaluated

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention

    Adherence (via TRAK Platform with email and chat)

  6. Patient global impression of change (PGI-I)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline). The score ranges from 1 to 7 and indicates that a higher score corresponds to worsening with treatment and a lower score to improvement with treatment.

    Patient global impression of change (PGI-I)

Other outcomes

  1. Body mass index (BMI)

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention.

    BMI can give a general idea of whether a person is at a healthy weight and It is important to know how this relates to endometriosis and pain

  2. Employment status

    Time frame: Pre-intervention (baseline)

    It is important to know the patient's current work status for her medical history and how this relates to endometriosis and pain

  3. Education level

    Time frame: Pre-intervention (baseline)

    It is important to know the patient's educational level for her medical history and how this relates to endometriosis and pain.

  4. Ethnicity

    Time frame: Pre-intervention (baseline)

    It is important to know the patient's ethnicity for her medical history and how this relates to endometriosis and pain.

  5. Maritial status

    Time frame: Pre-intervention (baseline)

    It is important to know the patient's marital status for her medical history and how this relates to endometriosis and pain.

  6. Number of children

    Time frame: Pre-intervention (baseline)

    It is important to know if and how many children the patient has for her medical history and how this relates to endometriosis and pain.

  7. Age

    Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention.

    It is important to know the patient's age for her medical history and how this relates to endometriosis and pain.

Study contacts

Contact information is provided by the study sponsor or research team.

María Torres-Lacomba, PhD

CONTACT

[email protected]

918856875

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jan 17, 2024
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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