ISRCTN98833037Active, not recruiting未知
Autoimmunity-informed phenotyping in chronic non-specific low-back pain
niversity of Liverpool0 sites100 target enrollmentStarted: June 23, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. 18 years or older
- •2. Presence of non-specific LBP without the presence of another condition to explain the pain (ie. cancer, primary musculoskeletal conditions, sciatica)
- •3. Chronic NsLBP defined as pain persisting for >12 weeks, with pain occurring >4 days/week
- •4. Non-specific LBP as defined topographically and temporally by the Delphi definition
- •5. Average weekly pain intensity exceeding 6/10 on VAS scoring
- •6. LBP that causes severe disability, as defined by the Modified Oswestry Low Back Pain Disability Questionnaire (MODI)
- •7. Pain may radiate down the buttocks or backs of legs but must not radiate below the knees
- •8. In patients with features of more widespread, non-specific pain, the low-back pain must be the predominant complaint of pain and the pain intensity of these other pains should not exceed 3/10 on VAS scoring
Exclusion Criteria
- •1. Pregnant or breastfeeding patients
- •2. Patients with immune deficiency or taking immune modulating drugs
- •3. Patients with an acute systemic disorder
- •4. Language other than English as first language
Investigators
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