Pain Education in Chronic Low Back Pain

Sponsor
Istituti Clinici Scientifici Maugeri SpA (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05697848
Collaborator
(none)
40
1
2
21.8
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiotherapy combined with Pain Education
  • Other: Physiotherapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pain Education: Treatment of Patients Affected by Chronic Low Back Pain, Randomized Controlled Study
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.

Active Comparator: Control group

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

Other: Physiotherapy
Patients with chronic low back pain receive manual therapy treatment

Outcome Measures

Primary Outcome Measures

  1. NRS [Baseline]

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

  2. NRS [4 weeks]

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

  3. NRS [6 months]

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

  4. PCS [Baseline]

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

  5. PCS [4 weeks]

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

  6. PCS [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Presence of neurological symptoms on provocative tests

  • Recent surgical procedure

  • Patients suffering from fibromyalgia or other rheumatological pathology

  • Psychiatric pathologies

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituti Clinici Scientifici Maugeri Milano Italy

Sponsors and Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matteo Gallotta, Physiotherapist, Istituti Clinici Scientifici Maugeri SpA
ClinicalTrials.gov Identifier:
NCT05697848
Other Study ID Numbers:
  • CE2556
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023