Open-label Placebo in Manual Therapy

Low Back Pain, Recurrent Clinical Trial

Official title:

Open-label Placebo in Manual Therapies: a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306742
• Other study ID #: ct9874
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Low Back Pain
• Low Back Pain, Recurrent

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