Open-label Placebo in Manual Therapy

August 5, 2025 updated by: Carolina Lavazza, Studio Osteopatico Busto Arsizio

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Varese
      • Saronno, Varese, Italy, 21047
        • CTFO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OMT

Participants will receive manual treatments. The treatment will include soft-tissue, joint mobilization techniques of the lumbar and sacral region. The treatment will also include the approach of the abdomen and lower limb with the same type of techniques.

Four treatments will be provided at 1, 2, 4 and 8 weeks.
Other: Osteopathic manipulative treatment
Manual therapy
Experimental: Open-label placebo
This group will receive an open-label placebo. The manual treatment will be performed in the same areas of the active comparator but using a very light pressure. Additionally, before the start of the treatment, Four treatments will be provided at 1, 2, 4 and 8 weeks.
Other: Open-label placebo
Light pressure manual therapy
No Intervention: Waiting list
Participants will receive no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Rating Scale
Time Frame: 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.
Change from baseline of numeric rating scale at week 2, 4 and 8.
Adverse effects
Time Frame: through study completion (8 weeks)
Number and types of adverse effects occurred after intervention
through study completion (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in measures of Von Frey filaments
Time Frame: from baseline at week 2,4 and 8.
Changes in pressure measures
from baseline at week 2,4 and 8.
Changes in algometer measurements
Time Frame: from baseline at week 2, 4 and 8
Changes in pressure with algometer
from baseline at week 2, 4 and 8
Use of analgesics
Time Frame: The week before the scheduled visit.
Usage (Yes/no), number and type of analgesics used
The week before the scheduled visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Studio Osteopatico Busto Arsizio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

June 18, 2025

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ct9874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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