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OpenTrials
Completed

NCT Number: NCT05697848

Pain Education in Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rehabilitation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Scientifici Maugeri

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy combined with Pain Education

Other

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

Physiotherapy

Other

Patients with chronic low back pain receive manual therapy treatment

Primary outcomes

  1. NRS

    Time frame: Baseline

    Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)

  2. NRS

    Time frame: 4 weeks

    Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)

  3. NRS

    Time frame: 6 months

    Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)

  4. PCS

    Time frame: Baseline

    Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.

  5. PCS

    Time frame: 4 weeks

    Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.

  6. PCS

    Time frame: 6 months

    Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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