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Clinical Trials/NCT05697848
NCT05697848
Completed
Not Applicable

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

Istituti Clinici Scientifici Maugeri SpA1 site in 1 country40 target enrollmentOctober 4, 2021
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ConditionsLow Back PainRehabilitationPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
40
Locations
1
Primary Endpoint
PCS
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 4, 2021
End Date
July 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matteo Gallotta

Physiotherapist

Istituti Clinici Scientifici Maugeri SpA

Eligibility Criteria

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

Outcomes

Primary Outcomes

PCS

Time Frame: 6 months

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

NRS

Time Frame: 6 months

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

Study Sites (1)

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