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OpenTrials
Completed

NCT Number: NCT06306742

Open-label Placebo in Manual Therapy

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

Completed

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Key information

Conditions

Low Back Pain, Recurrent Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CTFO

Saronno, Varese, 21047, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

open-label placebo

Other

Light pressure manual therapy

Osteopathic manipulative treatment

Other

Manual therapy

Primary outcomes

  1. 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.

  2. Adverse effects

    Time frame: through study completion (8 weeks)

    Number and types of adverse effects occurred after intervention

Secondary outcomes

  1. Change in measures of Von Frey filaments

    Time frame: from baseline at week 2,4 and 8.

    Changes in pressure measures

  2. Changes in algometer measurements

    Time frame: from baseline at week 2, 4 and 8

    Changes in pressure with algometer

  3. Use of analgesics

    Time frame: The week before the scheduled visit.

    Usage (Yes/no), number and type of analgesics used

Sponsors and collaborators

Lead sponsor

Studio Osteopatico Busto Arsizio

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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