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Low Back PainNCT04399473

Mediators and Moderators of Pain Neuroscience Education on Disability of Patients With Nonspecific Chronic Low Back Pain

An observational study of Low Back Pain, run by University of Utah at 6 sites in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Low Back Pain
What is being tested?
Pain Neuroscience Education (PNE)
How many people
249 participants
Where
6 sitesSaudi Arabia
Study dates
29 Nov 2020to 30 Dec 2021
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Nonspecific Chronic Low Back Pain (NCLBP)

Who may be able to join

  • 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%.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Saudi Arabia6 sites
  • East Jeddah General Hospital-Physical Therapy Department

    Jeddah, Mecca Region, 22253

  • King Abdulaziz Hospital-Rehabilitation Center

    Jeddah, Mecca Region, 22421

  • King Fahad General Hospital-Physical Therapy Department

    Jeddah, Mecca Region, 23325

  • King Abdullah Complex-Physical Therapy Department

    Jeddah, Mecca Region, 23826

  • King Fiasal Hospital-Physical Therapy Department

    Ta'if, Mecca Region, 26514

  • King Abdulaziz Hospital-Phyiscal Therapy Department

    Ta'if, Mecca Region, 26521

Other trials in Saudi Arabia

About this study

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).

Read the detailed description

Low back pain (LBP) is one of the most disabling conditions and has major socio-economic consequences. The prevalence of LBP among the population worldwide ranges between 15 and 45%. In the Kingdom of Saudi Arabia (KSA), the prevalence of LBP reported being around 18.8% among the population. Patient beliefs about back pain, pain self-efficacy, pain catastrophizing and expectation all seem to play a role in recovery. In fact, clinical guidelines recommended the treatment of non-specific chronic LBP should be considered within a multi-factorial biopsychosocial (BPS) framework. Exactly how this treatment should be delivered is not clear.

Pain neuroscience education (PNE) is a cognitive-based education that helps to educate patients about pain by focusing on neurobiology, neurophysiology and the processing and representation of pain. Even though PNE as intervention helps to improve pain, disability and other patient outcome, mixed results on its efficacy have seen in many studies. Since any complicated interventions are usually assessed by their effects on outcomes such as disability and pain, most do not target these outcomes directly; instead, they target mediating factors that are assumed to cause changes in these outcomes. In particular self-efficacy, pain catastrophizing and a patient's beliefs about back pain are thought to mediate the PNE-disability relationship since most of these cognitive factors are either highly correlated with disability or predictors for disability. The justifications for choosing these potential mediating factors: (1) self-efficacy has been shown to mediate the development of disability and is the most commonly identified mediator for psychological and behavior change interventions; (2) a study has shown that higher levels of pain catastrophizing are strongly correlated with higher levels of pain intensity and disability; and (3) a study has shown that beliefs about the consequences of LBP can influence patients' perceived pain and disability. However, the mechanisms underlying PNE effects, or the effect of PNE on mediating factors and its subsequent effect on disability as an outcome, has not been yet investigated. That leads to a knowledge gap in the evidence for understanding how PNE exerts its effect on disability. Also, identifying potential moderating factors that influence the PNE-disability relationship needs further investigation. In particular, expectation is thought to moderate the PNE-disability relationship because there are studies identified a link between expectation and clinical outcomes in patients with LBP. No study has explored the relationship between expectancy and clinical outcomes in the context of PNE. So, the influence of patient expectation on the magnitude of PNE effect on disability needs investigation.

The purpose of this 18-months project is understanding the underlying mechanisms of how PNE impacts disability. This project is significant because it will help us understand how PNE works by studying the underlying mechanisms and for whom and under what circumstances will PNE produces the greatest clinical benefits on the disability for patients with chronic LBP. Knowing how certain factors work will help PTs to enhance the elements of PNE that hopefully will target patient-specific factors and subsequently will reduce disability.

Conditions
Low Back Pain
Being tested
Pain Neuroscience Education (PNE)
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Neuroscience Education (PNE)Behavioural

    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.

Study groups in NCT04399473
Study groupRoleWhat they receive
Control group: Usual PT CareNot described
Experimental group: PNE + Usual PT CareParticipants in this arm will receive PNE education in addition to Usual PT Care
Receives: Behavioral: Pain Neuroscience Education (PNE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oswestry Disability Index (ODI)(Arabic version).

    Change score of disability scores from baseline.

    Measured: 2 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start29 Nov 2020
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
249 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399473
Sponsor's protocol ID
133302
Status last verified
Jan 2022
First submitted
19 May 2020
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by University of Utah at 6 sites in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI)(Arabic version). (time frame: 2 week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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