NCT05697848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

January 13, 2023

Last Update Submit

November 24, 2023

Conditions

Low Back PainRehabilitationPain

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Pain Education group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Physiotherapy

Interventions

Physiotherapy combined with Pain EducationOTHER

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

Pain Education group
PhysiotherapyOTHER

Patients with chronic low back pain receive manual therapy treatment

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Milan, Italy

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 26, 2023

Study Start

October 4, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)