Whole-Body Cryotherapy as a Non-Pharmacological Treatment to Reduce Chronic Pelvic Pain and Improve Quality of Life in People With Endometriosis

NCT07603960 | Recruiting

• 2 other identifiers: AC25234366671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate whether whole-body cryotherapy (a brief exposure to very cold temperatures) can help reduce pain and improve quality of life in people living with endometriosis, and whether it may represent a safe, non-pharmacological approach to managing endometriosis-related symptoms. Up to 30 participants with symptomatic endometriosis (chronic pelvic pain for more than six months) will be recruited over a 12-month period. Participants will attend two study visits at the hospital, approximately four weeks apart. Between these visits, participants will undergo five whole-body cryotherapy sessions, each lasting approximately 3 minutes. During cryotherapy, participants stand in a specialised chamber where the body is briefly exposed to cold, dry air (around -120°C). During the study, will be assessed changes in systemic inflammation and biological markers using blood, saliva, urine, vaginal, and stool samples. Data will be collected using questionnaires evaluating pain and related symptoms, quality of life, sleep, fatigue, intestinal symptoms, and overall wellbeing. The active study phase lasts approximately 4-6 weeks. A final follow-up assessment at 15 weeks will be conducted remotely using questionnaires and self-collected samples.

Conditions

Endometriosis

Keywords

endometriosis; cryotherapy; inflammation; pain; chronic pelvic pain; endometriosis-associated pain

Outcome Measures

Primary Outcomes (1)

• Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS)

  The Numerical Rating Scale (NRS) ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Participants will rate their average pain over the preceding week at baseline and at 4 weeks following completion of the cryotherapy intervention.

  From baseline to 4 weeks post-intervention

Secondary Outcomes (19)

• Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS)

  From baseline to 15 weeks

• Change in neuropathic pain assessed by the PainDETECT questionnaire (PD-Q)

  From baseline to 4 weeks and 15 weeks

• Change in quality of life assessed by Endometriosis Health Profile (EHP-30)

  From baseline to 4 weeks and 15 weeks

• Change in health-related quality of life assessed by EQ-5D-5L questionnaire

  From baseline to 4 weeks and 15 weeks

• Change in severity of fibromyalgia symptoms assessed by Fibromyalgia Impact questionnaire

  From baseline to 4 weeks and 15 weeks

Study Arms (1)

Whole-Body Cryotherapy in Endometriosis

EXPERIMENTAL

Participants with symptomatic endometriosis will undergo a structured course of whole-body cryotherapy consisting of five sessions over approximately two weeks. Each session involves brief exposure (approximately 3 minutes) to extremely cold, dry air (around -120°C) in a specialised cryotherapy chamber. Clinical and biological assessments will be conducted before and after the intervention period.

Procedure: Whole-Body Cryotherapy

Interventions

Whole-Body Cryotherapy PROCEDURE

Whole-body cryotherapy is a non-pharmacological intervention involving brief exposure of the body to extremely cold, dry air (typically around -110°C to -140°C) in a specialised cryotherapy chamber. Each session lasts approximately 2-3 minutes and is conducted under controlled conditions. The intervention is designed to induce physiological responses including vasoconstriction, modulation of inflammatory pathways, and potential analgesic effects.

Also known as: WBCT

Whole-Body Cryotherapy in Endometriosis

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or assigned female at birth
• Aged 16 or over
• Endometriosis identified at laparoscopy or imaging, performed within the last ten years
• Chronic pelvic pain for more than six months
• Willing to comply with the treatment
• Willing to use effective contraception throughout the trial (if needed)
• Willing and able to give informed consent

You may not qualify if:

• Pregnant, breastfeeding or actively trying to get pregnant
• Post-menopausal (no periods for \>12 months and not taking hormonal treatments to prevent periods, or bilateral oophorectomy performed)
• Previous hysterectomy with bilateral oophorectomy
• Raynaud's Disease
• Current treatment for malignancy
• Diabetes
• Known hypothyroidism
• Pre-existing or current diagnosis of anaemia
• Cardiovascular disease: severe hypertension (180/100, unstable angina, arrhythmia, recent (\<6months) myocardial infarction, peripheral artery disease, cardiac pacemaker, recent (\<6months) stroke or transient ischaemic attack)
• Acute kidney and urinary tract diseases
• Cryoglobulinemia
• Previous venous thromboembolism or peripheral artery occlusive disease
• Cold urticaria
• Livedo reticularis
• Open wounds or ulcers, large-area bacterial and viral skin infections

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4UX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Endometriosis; Inflammation; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 22, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Locations

GB (1)