Back to results

Pain Education in Chronic Low Back Pain

Primary Purpose

Low Back Pain, Rehabilitation, Pain

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Physiotherapy combined with Pain Education

Physiotherapy

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istituti Clinici Scientifici Maugeri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Education group

Control group

Arm Description

The patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ).

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

Outcomes

Primary Outcome Measures

NRS

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

NRS

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

NRS

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

PCS

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

PCS

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

PCS

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05697848

First Posted

January 13, 2023

Last Updated

January 24, 2023

Sponsor

Istituti Clinici Scientifici Maugeri SpA

1. Study Identification

Unique Protocol Identification Number

NCT05697848

Brief Title

Pain Education in Chronic Low Back Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 4, 2021 (Actual)

Primary Completion Date

July 31, 2023 (Anticipated)

Study Completion Date

July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Rehabilitation, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pain Education group

Arm Type

Experimental

Arm Description

The patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ).

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Physiotherapy combined with Pain Education

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Physiotherapy

Intervention Description

Patients with chronic low back pain receive manual therapy treatment

Primary Outcome Measure Information:

Title

NRS

Description

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

Time Frame

Baseline

Title

NRS

Description

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

Time Frame

4 weeks

Title

NRS

Description

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

Time Frame

6 months

Title

PCS

Description

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

Time Frame

Baseline

Title

PCS

Description

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

Time Frame

4 weeks

Title

PCS

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Istituti Clinici Scientifici Maugeri

City

Milano

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pain Education in Chronic Low Back Pain

We'll reach out to this number within 24 hrs