Whole-Body Cryotherapy as a Non-Pharmacological Treatment to Reduce Chronic Pelvic Pain and Improve Quality of Life in People With Endometriosis
RecruitingNot applicableNCT07603960
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- An Exploratory Clinical Trial to Determine the Impact of Whole-body Cryotherapy on Endometriosis-associated Pain
- Conditions
- Interventions
- Procedure: Whole-Body Cryotherapy
- Sponsor
- University of Edinburgh
- Collaborators
- NHS Lothian
- Start date
- 2026-04-09
- Primary completion
- 2026-11
- Sex
- Female
- Age range
- from 16 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Uncontrolled seizure disorder * Known coagulopathy (eg von Willibrand disease, haemophilia) * Severe claustrophobia * Acute infections and fever * Intoxication (alcohol, drugs) * Signs or symptoms of cold allergy * Severe wasting diseases * Known Hepatitis B/C and/or HIV (due to Royal Mail restrictions on biospecimen postage)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07603960