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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigtes Königreich
    • Scotland
      • Edinburgh, Scotland, Vereinigtes Königreich, EH16 4UX
        • Rekrutierung
        • Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edinburgh
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in average pain over the preceding week measured by an 11-point Numerical Rating Scale (NRS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Edinburgh

Mitarbeiter

NHS Lothian

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. April 2026

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

31. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

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Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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