Whole-Body Cryotherapy as a Non-Pharmacological Treatment to Reduce Chronic Pelvic Pain and Improve Quality of Life in People With Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole-Body Cryotherapy.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Clinical Trial to Determine the Impact of Whole-body Cryotherapy on Endometriosis-associated Pain
Overview
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.
Detailed description
Endometriosis is a chronic inflammatory and estrogen-dependent condition characterized by the presence of endometrial-like tissue outside the uterus, commonly associated with persistent pelvic pain, reduced quality of life, and significant long-term morbidity. Despite available hormonal and surgical treatments, a substantial proportion of individuals continue to experience chronic pain, highlighting an unmet need for novel therapeutic approaches. Current treatment strategies do not fully address the underlying inflammatory, neurovascular, and nociceptive mechanisms that contribute to pain persistence and central sensitization in endometriosis.
Whole-body cryotherapy (WBCT) is a non-pharmacological intervention involving brief exposure to extremely low temperatures, which has been associated with anti-inflammatory, analgesic, and neuromodulatory effects in other chronic conditions. Proposed mechanisms include modulation of systemic inflammatory pathways, reduction of oxidative stress, and effects on central pain processing. However, the potential role of WBC in the management of endometriosis-associated pain has not yet been established.
This study is a single-site, single-arm interventional pilot study designed to evaluate the feasibility, safety, acceptability, and preliminary efficacy of a structured WBCT intervention in individuals with symptomatic endometriosis. In addition to clinical outcomes, the study aims to explore biological mechanisms underlying potential treatment effects through the assessment of systemic inflammatory and other biomarkers.
Participants will undergo a standardized course of WBCT sessions over a two-week period, with repeated clinical and biological assessments conducted at predefined timepoints. Clinical outcomes will include patient-reported measures of pain, quality of life, fatigue, sleep, and other symptom domains, as well as analgesic use and global impression of change. Feasibility outcomes will include recruitment rates, retention, and participant acceptability of the intervention and study procedures.
Biological assessments will include the collection of blood (venous and capillary), saliva, urine, vaginal, and stool samples to evaluate markers of systemic inflammation, stress, and gut health. Samples will be collected at baseline, during the intervention period, and at follow-up, enabling exploration of temporal changes associated with WBC exposure.
Study visits will be conducted at baseline and post-intervention, with an additional remote follow-up evaluation. The intervention phase includes multiple WBC sessions delivered at a dedicated facility, with complementary data collection performed both in-clinic and through self-collected samples.
The findings from this exploratory study will provide preliminary evidence on the clinical and biological effects of WBCT in endometriosis, inform the feasibility of larger controlled trials, and contribute to understanding whether WBCT may represent a novel non-pharmacological approach targeting inflammatory and nociceptive pathways in endometriosis-associated pain.
Interventions
- Procedure Whole-Body Cryotherapy
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.
Primary outcome measures
- Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS) [Time frame: From baseline to 4 weeks post-intervention]
Secondary outcome measures (12)
- Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS) [Time frame: From baseline to 15 weeks]
- Change in neuropathic pain assessed by the PainDETECT questionnaire (PD-Q) [Time frame: From baseline to 4 weeks and 15 weeks]
- Change in quality of life assessed by Endometriosis Health Profile (EHP-30) [Time frame: From baseline to 4 weeks and 15 weeks]
- Change in health-related quality of life assessed by EQ-5D-5L questionnaire [Time frame: From baseline to 4 weeks and 15 weeks]
- Change in severity of fibromyalgia symptoms assessed by Fibromyalgia Impact questionnaire [Time frame: From baseline to 4 weeks and 15 weeks]
- Change in fatigue assessed by the Fatigue Severity Scale (FSS) [Time frame: From baseline to 4 weeks and 15 weeks]
- Change in sleep quality assessed by the Sleep Timing Questionnaire (STQ) [Time frame: From baseline to 4 weeks and 15 weeks]
- Change in analgesic use during the study period [Time frame: From baseline to 4 weeks and 15 weeks]
- Feasibility assessed by recruitment and retention rates [Time frame: Frome baseline to study end. Up to 12 months]
- Patient satisfaction assessed by Patient Global Impression of Change (PGIC) questionnaire [Time frame: At 4 weeks and 15 weeks]
- Acceptability of the intervention assessed by a study-specific questionnaire [Time frame: At 4 weeks and 15 weeks]
- Change in cognitive symptoms (brain fog) assessed by the Brain Fog Scale (BFS) [Time frame: From baseline to 4 weeks and 15 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edin — Edinburgh
Identifiers
NCT: NCT07603960 · AC25234 · 366671