Pain Education in Chronic Low Back Pain

NCT ID: NCT05697848

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue.

The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a conventional treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain Rehabilitation Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pain Education group

The patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ).

Group Type EXPERIMENTAL

Physiotherapy combined with Pain Education

Intervention Type OTHER

Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.

Control group

The patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ).

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

Patients with chronic low back pain receive manual therapy treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physiotherapy combined with Pain Education

Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.

Intervention Type OTHER

Physiotherapy

Patients with chronic low back pain receive manual therapy treatment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age over 18
* Patients with low back pain of musculoskeletal origin for at least 3 months
* Patients free from NSAID and/or opioid analgesic therapy for at least 1 month
* Years of education: over 13
* Italian mother-tongue

Exclusion Criteria

* Presence of neurological symptoms on provocative tests
* Recent surgical procedure
* Patients suffering from fibromyalgia or other rheumatological pathology
* Psychiatric pathologies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matteo Gallotta

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituti Clinici Scientifici Maugeri

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CE2556

Identifier Type: -

Identifier Source: org_study_id