Open-label Placebo in Manual Therapy

Studio Osteopatico Busto Arsizio

Status and phase: Enrolling; Phase 2

Conditions: Low Back Pain, Recurrent

Treatments: Other: Osteopathic manipulative treatment; Other: Open-label placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06306742

ct9874

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

OMT

Active Comparator group

Description:

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.

Treatment:

Other: Osteopathic manipulative treatment

Open-label placebo

Experimental group

Description:

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.

Treatment:

Other: Open-label placebo

Waiting list

No Intervention group

Description:

Participants will receive no treatment.