Open-label Placebo in Manual Therapy

Phase 2

Recruiting

• Conditions: Low Back Pain, Recurrent
• Interventions: Other: Osteopathic manipulative treatment; Other: Open-label placebo

• Registration Number: NCT06306742
• Lead Sponsor: Studio Osteopatico Busto Arsizio

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-26
• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT	Osteopathic manipulative treatment	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.
Open-label placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Numeric Rating Scale	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.
Adverse effects	through study completion (8 weeks)	Number and types of adverse effects occurred after intervention

Secondary Outcome Measures

Name	Time	Method
Change in measures of Von Frey filaments	from baseline at week 2,4 and 8.	Changes in pressure measures
Changes in algometer measurements	from baseline at week 2, 4 and 8	Changes in pressure with algometer

Trial Locations

Locations (1)

CTFO; 🇮🇹 Saronno, Varese, Italy