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CompletedNCT05697848Updated Nov 27, 2023

Pain Education in Chronic Low Back Pain

An interventional study of Physiotherapy combined with Pain Education and Physiotherapy in Low Back Pain, Rehabilitation and Pain, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
  • Rehabilitation
  • Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 113 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Presence of neurological symptoms on provocative tests
  • Recent surgical procedure
  • Patients suffering from fibromyalgia or other rheumatological pathology
  • Psychiatric pathologies
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Pain Education group

    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

  • Active comparator
    Control group

    The patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ).

    Other: Physiotherapy

Interventions

  • OtherPhysiotherapy combined with Pain Education

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

  • OtherPhysiotherapy

    Patients with chronic low back pain receive manual therapy treatment

06

What researchers measure

Primary outcomes

  1. NRS

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

    Time frame: Baseline

  2. NRS

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

    Time frame: 4 weeks

  3. NRS

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

    Time frame: 6 months

  4. PCS

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

    Time frame: Baseline

  5. PCS

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

    Time frame: 4 weeks

  6. PCS

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

    Time frame: 6 months

07

Study locations

1 site
  • Istituti Clinici Scientifici Maugeri
    Milano, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05697848
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Responsible party
Matteo Gallotta (Physiotherapist, Istituti Clinici Scientifici Maugeri SpA) — Principal investigator
First posted
Jan 26, 2023
Start date
Oct 4, 2021
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Nov 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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