Low Back Pain, Recurrent
Conditions
Keywords
Placebo, Placebo effect, Open-label trial
Brief summary
to investigate the effects of placebo in patients affected by low-back pain.
Interventions
OTHEROpen-label placebo
Light pressure manual therapy
OTHEROsteopathic manipulative treatment
Manual therapy
Sponsors
Studio Osteopatico Busto Arsizio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Use of analgesics | The week before the scheduled visit. | Usage (Yes/no), number and type of analgesics used |
Countries
Italy
Outcome results
None listed