Pain Education in Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain, Rehabilitation, Pain

Intervention / Treatment
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* Other: Physiotherapy combined with Pain Education
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Education group<br>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<br>* Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.<br>|
| Active Comparator: Control group<br>The patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ). | Other: Physiotherapy<br>* Patients with chronic low back pain receive manual therapy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

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