Mediators and Moderators of Pain Neuroscience Education on Disability of Patients With Nonspecific Chronic Low Back Pain
1 other identifier
observational
249
1 country
6
Brief Summary
The purpose of this observational study is understanding the underlying mechanisms of how PNE impacts disability in chronic low back pain patients (CLBP). The investigator will explore whether the PNE effect on patient disability is mediated by changes in pain catastrophizing, pain self-efficacy and patient beliefs about pain. Also, the investigator will explore whether the effect of PNE on disability is moderated by patient expectation.The observational multisite pre-post cohort study will be conducted in PT clinics in the Kingdom of Saudi Arabia (KSA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Start
First participant enrolled
November 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJanuary 27, 2025
January 1, 2022
1.1 years
May 19, 2020
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Oswestry Disability Index (ODI)(Arabic version).
Change score of disability scores from baseline.
2 week.
Other Outcomes (4)
Pain Self-Efficacy (PSE).
2 week.
Pain Catastrophism.
2 week.
Patient Back Beliefs.
2 week.
- +1 more other outcomes
Study Arms (2)
Control group: Usual PT Care
Experimental group: PNE + Usual PT Care
Participants in this arm will receive PNE education in addition to Usual PT Care
Interventions
Participates in the experimental group will receive 15mins X 4 sessions of pain education by the eligible trained physical therapist in addition to usual care PT treatment.
Eligibility Criteria
Patients with Nonspecific Chronic Low Back Pain (NCLBP)
You may qualify if:
- Pain between the 12th rib and buttocks with or without symptoms into one or both legs which originate from the lumber region.
- Pain \>12 weeks.
- Oswestry disability score =\>20%.
You may not qualify if:
- No surgery to the lumbosacral spine in the last 12 months.
- No evidence of "Red flags" conditions (e.g., cauda equina, neurological deficits, cancer, fracture or infection).
- Not currently receiving any intervention for LBP from other healthcare provider (e.g., physical therapy, massage therapy, etc.).
- Not currently known to be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
East Jeddah General Hospital-Physical Therapy Department
Jeddah, Mecca Region, 22253, Saudi Arabia
King Abdulaziz Hospital-Rehabilitation Center
Jeddah, Mecca Region, 22421, Saudi Arabia
King Fahad General Hospital-Physical Therapy Department
Jeddah, Mecca Region, 23325, Saudi Arabia
King Abdullah Complex-Physical Therapy Department
Jeddah, Mecca Region, 23826, Saudi Arabia
King Fiasal Hospital-Physical Therapy Department
Ta'if, Mecca Region, 26514, Saudi Arabia
King Abdulaziz Hospital-Phyiscal Therapy Department
Ta'if, Mecca Region, 26521, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 22, 2020
Study Start
November 29, 2020
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
January 27, 2025
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share