Open-label Placebo in Manual Therapy

NCT06306742 | Completed Phase 2

• 1 other identifier: ct9874
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain, Recurrent

Keywords

Placebo; Placebo effect; Open-label trial

Outcome Measures

Primary Outcomes (2)

• 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.

• Adverse effects

  Number and types of adverse effects occurred after intervention

  through study completion (8 weeks)

Secondary Outcomes (3)

• Change in measures of Von Frey filaments

  from baseline at week 2,4 and 8.

• Changes in algometer measurements

  from baseline at week 2, 4 and 8

• Use of analgesics

  The week before the scheduled visit.

Study Arms (3)

OMT

ACTIVE COMPARATOR

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

Open-label placebo

EXPERIMENTAL

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

Waiting list

NO INTERVENTION

Participants will receive no treatment.

Interventions

Open-label placebo OTHER

Light pressure manual therapy

Open-label placebo

Osteopathic manipulative treatment OTHER

Manual therapy

OMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Studio Osteopatico Busto Arsizio: lead

Study Sites (1)

CTFO

Saronno, Varese, 21047, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 12, 2024
• Study Start: February 26, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: August 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)