Measurement of Substance P in Saliva of Low Back Pain Patients
Not Applicable
Terminated
- Conditions
- Low Back Pain
- Registration Number
- NCT00735735
- Lead Sponsor
- Kovacs Foundation
- Brief Summary
The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain
- A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)
- Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)
For healthy subjects:
- Volunteers with no pain (anywhere)
- That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.
Exclusion Criteria
- Subjects with pain that is additional to or different from chronic low back pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Levels of Substance P in the saliva 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kovacs Foundation
🇪🇸Palma de Mallorca, Balearic Islands, Spain