Pain Education in Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain; Rehabilitation; Pain
• Interventions: Other: Physiotherapy combined with Pain Education; Other: Physiotherapy

• Registration Number: NCT05697848
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Education group	Physiotherapy combined with Pain Education	The patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ).
Control group	Physiotherapy	The patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ).

Primary Outcome Measures

Name	Time	Method
PCS	6 months	Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
NRS	6 months	Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri; 🇮🇹 Milano, Italy