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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06306742
Other study ID # ct9874
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 26, 2024
Est. completion date June 2026

Study information

Verified date March 2024
Source Studio Osteopatico Busto Arsizio
Contact Carolina Lavazza
Phone +39 02 96701013
Email carolina.lavazza@docenti.aimoedu.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to investigate the effects of placebo in patients affected by low-back pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Open-label placebo
Light pressure manual therapy
Osteopathic manipulative treatment
Manual therapy

Locations

Country Name City State
Italy CTFO Saronno Varese

Sponsors (1)

Lead Sponsor Collaborator
Studio Osteopatico Busto Arsizio

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Numeric Rating Scale 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. Change from baseline of numeric rating scale at week 2, 4 and 8.
Primary Adverse effects Number and types of adverse effects occurred after intervention through study completion (8 weeks)
Secondary Change in measures of Von Frey filaments Changes in pressure measures from baseline at week 2,4 and 8.
Secondary Changes in algometer measurements Changes in pressure with algometer from baseline at week 2, 4 and 8
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