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| ID | Type | Description | Link |
|---|---|---|---|
| 366671 | Other Identifier | IRAS Project ID (UK Health Research Authority) |
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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-Body Cryotherapy in Endometriosis | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-Body Cryotherapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 4 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edinburgh | Recruiting | Edinburgh | Scotland | EH16 4UX | United Kingdom |
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.
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| 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. | From baseline to 4 weeks and 15 weeks |
| 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. | From baseline to 4 weeks and 15 weeks |
| 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). | From baseline to 4 weeks and 15 weeks |
| 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. | From baseline to 4 weeks and 15 weeks |
| 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. | From baseline to 4 weeks and 15 weeks |
| 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). | From baseline to 4 weeks and 15 weeks |
| Change in analgesic use during the study period | Participant-reported frequency and quantity of analgesic use. | From baseline to 4 weeks and 15 weeks |
| Feasibility assessed by recruitment and retention rates | 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 | 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:
| At 4 weeks and 15 weeks |
| 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. | At 4 weeks and 15 weeks |
| 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. | From baseline to 4 weeks and 15 weeks |
| 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). | From baseline to 4 weeks and 15 weeks |
| 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) | From baseline to 4 weeks after cryotherapy sessions and 15 weeks |
| Change in salivary alpha-amylase activity | 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 | 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 | 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 | 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 | Includes gut microbiome composition assessed in stool samples. | From baseline to 4 weeks after cryotherapy sessions and 15 weeks |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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