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EndometriosisCHILL-EndoNCT07603960

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

A study testing Whole-Body Cryotherapy in people with Endometriosis, run by University of Edinburgh at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Endometriosis
What is being tested?
Whole-Body Cryotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
9 Apr 2026to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH16 4UX

    Lucy Whitaker, 03116518321, ETMT@ed.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: An Exploratory Clinical Trial to Determine the Impact of Whole-body Cryotherapy on Endometriosis-associated Pain

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).

Read more

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.

Read the 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.

Conditions
Endometriosis
Being tested
Whole-Body Cryotherapy
Keywords
endometriosis, cryotherapy, inflammation, pain, chronic pelvic pain, endometriosis-associated pain
Medical subject headings
Endometriosis, Inflammation, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole-Body CryotherapyProcedure or surgery

    Also called WBCT

    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.

Study groups in NCT07603960
Study groupRoleWhat they receive
Whole-Body Cryotherapy in EndometriosisExperimentalParticipants 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.
Receives: Procedure: Whole-Body Cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 4 weeks post-intervention

Secondary outcomes (19)
  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 15 weeks.

    Measured: From baseline to 15 weeks

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

    The PainDETECT questionnaire (PD-Q) is a validated 9-item screening tool used to assess neuropathic pain components. Scores range from -1 to 38, with higher scores indicating a higher likelihood of neuropathic pain.

    Measured: From baseline to 4 weeks and 15 weeks

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

    The Endometriosis Health Profile (EHP-30) questionnaire is a validated tool used to assess quality of life components over the previous four weeks. It includes 30 core questions (five scales: pain, control, emotions, social support, self-image) scoring 0-100, where higher scores indicate worse health.

    Measured: From baseline to 4 weeks and 15 weeks

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

    The EQ-5D-5L questionnaire is a validated 5-level tool used to measure health-related quality of life, consisting of a descriptive system covering five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a vertical visual analogue scale (VAS) ranging from 0 (worst) to 100 (best).

    Measured: From baseline to 4 weeks and 15 weeks

  5. Change in severity of fibromyalgia symptoms assessed by Fibromyalgia Impact questionnaire

    The Fibromyalgia Impact questionnaire is a validated tool used that measure the severity of fibromyalgia, its impact on daily life, and treatment progress. Scores range from 0 to 100, where higher scores indicate greater impairment. A score of 50 indicates an average patient, while over 70 indicates severe impairment.

    Measured: From baseline to 4 weeks and 15 weeks

  6. Change in fatigue assessed by the Fatigue Severity Scale (FSS)

    The Fatigue Severity Scale (FSS) questionnaire is a 9-item self-report questionnaire designed to measure the severity of fatigue and its impact on daily functioning, particularly for chronic conditions. Respondents rate statements on a 7-point Likert scale (9-63), with higher scores (up to 63) indicating greater fatigue severity.

    Measured: From baseline to 4 weeks and 15 weeks

  7. Change in sleep quality assessed by the Sleep Timing Questionnaire (STQ)

    The Sleep Timing Questionnaire (STQ) is a 18-item, self-report tool used to measure habitual bedtimes, wake times, sleep latency, and wake after sleep onset (like a sleep diary).

    Measured: From baseline to 4 weeks and 15 weeks

  8. Change in analgesic use during the study period

    Participant-reported frequency and quantity of analgesic use.

    Measured: From baseline to 4 weeks and 15 weeks

  9. Feasibility assessed by recruitment and retention rates

    Proportion of eligible participants enrolled and completing study follow-up

    Measured: Frome baseline to study end. Up to 12 months

  10. Patient satisfaction assessed by Patient Global Impression of Change (PGIC) questionnaire

    The Patient Global Impression of Change (PGIC) is a 7-point, self-reported scale used in clinical practice to evaluate a patient's overall perception of improvement following the intervention.

    Patients select one of the following to describe their change:

    1. Very Much Improved
    2. Much Improved
    3. Minimally Improved
    4. No Change
    5. Minimally Worse
    6. Much Worse
    7. Very Much Worse

    Measured: At 4 weeks and 15 weeks

  11. Acceptability of the intervention assessed by a study-specific questionnaire

    Overall acceptability will also be evaluated using a study-specific questionnaire assessing participant satisfaction (e.g. perceived effectiveness, and self-efficacy) with the intervention and study procedures.

    Measured: At 4 weeks and 15 weeks

  12. Change in cognitive symptoms (brain fog) assessed by the Brain Fog Scale (BFS)

    The Brain Fog Scale (BFS) is a validated, self-report questionnaire designed to measure the severity of "brain fog" (cognitive difficulties such as memory impairment, lack of focus, and mental confusion and fatigue). It consists of 9 items rated on a 7-point Likert scale, with higher scores indicating greater symptom severity.

    Measured: From baseline to 4 weeks and 15 weeks

  13. Change in gastrointestinal symptoms assessed by the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

    The IBS Symptom Severity Scale (IBS-SSS) is a 5-item, 500-point questionnaire used to measure the intensity of Irritable Bowel Syndrome symptoms over the past 10 days. It evaluates pain severity/frequency, bloating, bowel habit dissatisfaction, and quality of life, categorizing IBS as "no symptoms" (<75), "mild" (75-174), "moderate" (175-299), or severe (300-500).

    Measured: From baseline to 4 weeks and 15 weeks

  14. Change in systemic inflammatory markers with cortisol concentration

    Includes serum and salivary cortisol measured in blood and saliva samples, reported in µg/dL (or nmol/L)

    Measured: From baseline to 4 weeks after cryotherapy sessions and 15 weeks

  15. Change in salivary alpha-amylase activity

    Includes salivary alpha-amylase measured in saliva samples, reported in U/mL

    Measured: From baseline to 4 weeks after cryotherapy sessions and 15 weeks

  16. Change in systemic inflammatory markers with C-reactive protein (CRP) concentration

    Includes serum C-reactive protein (CRP) levels in blood samples, reported in mg/L.

    Measured: From baseline to 4 weeks after cryotherapy sessions and 15 weeks

  17. Change in systemic inflammatory markers with inflammatory cytokine concentrations

    Includes inflammatory cytokines (e.g., IL-6, TNF-α, IL-1β) measured in serum/plasma samples, reported in pg/mL.

    Measured: From baseline to 4 weeks after cryotherapy sessions and 15 weeks

  18. Change in bowel inflammatory markers with faecal calprotectin concentration

    Includes faecal calprotectin measured in stool samples, reported in µg/g.

    Measured: From baseline to 4 weeks after cryotherapy sessions and 15 weeks

  19. Change in gut microbiome composition

    Includes gut microbiome composition assessed in stool samples.

    Measured: From baseline to 4 weeks after cryotherapy sessions and 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start9 Apr 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603960
Sponsor's protocol ID
AC25234
Other IDs
366671
Acronym
CHILL-Endo
Status last verified
Apr 2026
First submitted
5 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Requests for anonymised data sharing will be considered on a case by case basis by the trial management team with appropriate data sharing contracts in place.

Questions about this trial

What is this clinical trial studying?

A study testing Whole-Body Cryotherapy in people with Endometriosis, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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