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

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Whole-Body Cryotherapy

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Whole-Body Cryotherapy in EndometriosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
From baseline to 4 weeks post-intervention

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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).

Time frame
From baseline to 4 weeks and 15 weeks

Other outcomes

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