Fibromyaglia(FM)
Conditions
Interventions
Group 1:Ozonated water enema
Group 2:Deionized water enema
Sponsors
Department of Anesthesiology and Pain Mnagement, Shanghai East Hospital, School of Medicine, Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, no gender limit; 2. FM patients meeting ACR2016 diagnostic criteria; 3. NRS>=4, course of disease > 1 year; Oral duloxetine >=3 months; 4. The patient signed the informed consent voluntarily and could cooperate to complete the questionnaire survey.
Exclusion criteria
Exclusion criteria: 1. Broad bean disease patients; 2. Secondary to osteoarthritis, rheumatoid arthritis, hypothyroidism and other diseases; 3. Other diffuse soft tissue pain diseases; 4. Other immune system diseases; 5. Patients with neuropathic pain; 6. Complicated with malignant tumor or serious dysfunction of heart, lung, kidney and liver; 7. Allergic to ozone; 8. Patients with a history of alcohol, mental illness or substance abuse; 9. Patients taking NSaids, antibiotics, hormones or probiotics during the 3 months prior to the study; 10. Colonoscopy found colitis, multiple polyps and other intestinal diseases; 11. Patients who have received immunosuppressive therapy, received organ transplants or participated in clinical trials within 6 months; 12. Pregnant and lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Widespread Pain Index;Hamilton Anxiety Scale;Pittsburgh Sleep Quality Index;High-throughput sequencing of intestinal flora; | — |
Countries
China
Contacts
Public ContactLiao Lijun
Department of Anesthesiology and Pain Mnagement, Shanghai East Hospital, School of Medicine, Tongji University
Outcome results
None listed