Open-label Placebo in Manual Therapy
Phase 2
Recruiting
- Conditions
- Low Back Pain, Recurrent
- Registration Number
- NCT06306742
- Lead Sponsor
- Studio Osteopatico Busto Arsizio
- Brief Summary
to investigate the effects of placebo in patients affected by low-back pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.
-Patients will need to have a diagnosis of low back pain made by a physician
Exclusion Criteria
- pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases.
- Pregnant women
- patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial
- diseases that may affect the interpretation of results such as fibromyalgia
- patients currently being treated by other specialists or other manual therapists
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Numeric Rating Scale Change from baseline of numeric rating scale at week 2, 4 and 8. a verbal determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain.
Adverse effects through study completion (8 weeks) Number and types of adverse effects occurred after intervention
- Secondary Outcome Measures
Name Time Method Change in measures of Von Frey filaments from baseline at week 2,4 and 8. Changes in pressure measures
Changes in algometer measurements from baseline at week 2, 4 and 8 Changes in pressure with algometer
Trial Locations
- Locations (1)
CTFO
🇮🇹Saronno, Varese, Italy
CTFO🇮🇹Saronno, Varese, ItalyCFTOContact+39 02 96701013cfto@aimoedu.it