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

NCT06209346 | Recruiting DMC

• 1 other identifier: CEID/2023/6/106
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Endometriosis; Chronic Pelvic Pain Syndrome

Keywords

endometriosis; chronic pelvic pain; physical therapy; pain education

Outcome Measures

Primary Outcomes (6)

• Health Status Questionnaire (SF-12)

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

  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.

• Visual Numeric Scale (VNS)

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

  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.

• Endometriosis Health Profile (EHP-30)

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

  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.

• Index of Sexual Function (IFSF)

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

  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.

• Tampa Scale of Kinesiophobia (TSK)

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

  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

• Pain Catastrophizing Scale (PCS)

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

  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.

Secondary Outcomes (6)

• Hospital Anxiety and Depression Scale (HADS)

  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

• International Physical Activity Questionnaire (IPAQ)

  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

• Pittsburg Sleep Quality Index (PSQI)

  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).

• Perceived Stress Scale (PSS)

  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.

• Patient's adherence will be evaluated

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

Other Outcomes (7)

• Body mass index (BMI)

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

• Employment status

  Pre-intervention (baseline)

• Education level

  Pre-intervention (baseline)

Study Arms (2)

TeleRehab Group

EXPERIMENTAL

The duration of treatment for the TeleRehab 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 TE program and respiratory control practices. All the sessions mentioned above will be in online format, through the TRAK platform.

Other: TeleRehab Group

Advices Group

ACTIVE COMPARATOR

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. o Participants in the Advices Group will have the same follow-up assessments as the TeleRehab Group and will receive informative material. They will not have access to the audiovisual material generated for the TeleRehabGroup.

Other: Advices Group

Interventions

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.

Also known as: TrhbG

TeleRehab Group

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.

Also known as: AG

Advices Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

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

Alcalà de Henares, Madrid, 28871, Spain

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

María Torres-Lacomba, PhD

CONTACT

918856875; maria.torres@uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 17, 2024
• Study Start: November 27, 2023
• Primary Completion: January 17, 2025
• Study Completion (Estimated): January 17, 2027
• Last Updated: January 17, 2024

Record last verified: 2023-07

Locations

ES (1)