Pain Education in Chronic Low Back Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697848
• Other study ID #: CE2556
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain
• Rehabilitation

Intervention

Other:
• Physiotherapy combined with Pain Education
Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.
• Physiotherapy
Patients with chronic low back pain receive manual therapy treatment

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

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