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

15 mei 2026 bijgewerkt door: University of Edinburgh

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).

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigd Koninkrijk
    • Scotland
      • Edinburgh, Scotland, Verenigd Koninkrijk, EH16 4UX
        • Werving
        • Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edinburgh
        • Contact:
          • Lucy Whitaker
          • Telefoonnummer: 03116518321
          • E-mail: ETMT@ed.ac.uk

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Whole-Body Cryotherapy in Endometriosis
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
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.
Andere namen:
  • WBCT

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS)
Tijdsspanne: From baseline to 4 weeks post-intervention
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS)
Tijdsspanne: From baseline to 15 weeks
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.
From baseline to 15 weeks
Change in neuropathic pain assessed by the PainDETECT questionnaire (PD-Q)
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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.
From baseline to 4 weeks and 15 weeks
Change in quality of life assessed by Endometriosis Health Profile (EHP-30)
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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.
From baseline to 4 weeks and 15 weeks
Change in health-related quality of life assessed by EQ-5D-5L questionnaire
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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).
From baseline to 4 weeks and 15 weeks
Change in severity of fibromyalgia symptoms assessed by Fibromyalgia Impact questionnaire
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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.
From baseline to 4 weeks and 15 weeks
Change in fatigue assessed by the Fatigue Severity Scale (FSS)
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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.
From baseline to 4 weeks and 15 weeks
Change in sleep quality assessed by the Sleep Timing Questionnaire (STQ)
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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).
From baseline to 4 weeks and 15 weeks
Change in analgesic use during the study period
Tijdsspanne: From baseline to 4 weeks and 15 weeks
Participant-reported frequency and quantity of analgesic use.
From baseline to 4 weeks and 15 weeks
Feasibility assessed by recruitment and retention rates
Tijdsspanne: Frome baseline to study end. Up to 12 months
Proportion of eligible participants enrolled and completing study follow-up
Frome baseline to study end. Up to 12 months
Patient satisfaction assessed by Patient Global Impression of Change (PGIC) questionnaire
Tijdsspanne: At 4 weeks and 15 weeks

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
At 4 weeks and 15 weeks
Acceptability of the intervention assessed by a study-specific questionnaire
Tijdsspanne: At 4 weeks and 15 weeks
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.
At 4 weeks and 15 weeks
Change in cognitive symptoms (brain fog) assessed by the Brain Fog Scale (BFS)
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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.
From baseline to 4 weeks and 15 weeks
Change in gastrointestinal symptoms assessed by the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Tijdsspanne: From baseline to 4 weeks and 15 weeks
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).
From baseline to 4 weeks and 15 weeks
Change in systemic inflammatory markers with cortisol concentration
Tijdsspanne: From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Includes serum and salivary cortisol measured in blood and saliva samples, reported in µg/dL (or nmol/L)
From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Change in salivary alpha-amylase activity
Tijdsspanne: From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Includes salivary alpha-amylase measured in saliva samples, reported in U/mL
From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Change in systemic inflammatory markers with C-reactive protein (CRP) concentration
Tijdsspanne: From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Includes serum C-reactive protein (CRP) levels in blood samples, reported in mg/L.
From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Change in systemic inflammatory markers with inflammatory cytokine concentrations
Tijdsspanne: From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Includes inflammatory cytokines (e.g., IL-6, TNF-α, IL-1β) measured in serum/plasma samples, reported in pg/mL.
From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Change in bowel inflammatory markers with faecal calprotectin concentration
Tijdsspanne: From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Includes faecal calprotectin measured in stool samples, reported in µg/g.
From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Change in gut microbiome composition
Tijdsspanne: From baseline to 4 weeks after cryotherapy sessions and 15 weeks
Includes gut microbiome composition assessed in stool samples.
From baseline to 4 weeks after cryotherapy sessions and 15 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Edinburgh

Medewerkers

NHS Lothian

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 april 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

31 mei 2027

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

15 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AC25234
  • 366671 (Andere identificatie: IRAS Project ID (UK Health Research Authority))

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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