Pain Education in Chronic Low Back Pain

November 24, 2023 updated by: Matteo Gallotta, Istituti Clinici Scientifici Maugeri SpA

Pain Education: Treatment of Patients Affected by Chronic Low Back Pain, Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Education group
The patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ).
Other: Physiotherapy combined with Pain Education
Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.
Active Comparator: Control group
The patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ).
Other: Physiotherapy
Patients with chronic low back pain receive manual therapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS
Time Frame: Baseline
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
Baseline
NRS
Time Frame: 4 weeks
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
4 weeks
NRS
Time Frame: 6 months
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
6 months
PCS
Time Frame: Baseline
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Baseline
PCS
Time Frame: 4 weeks
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
4 weeks
PCS
Time Frame: 6 months
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE2556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Physiotherapy combined with Pain Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe