AzTrials
AzTrials

Chronic Low Back PainNCT01882686

Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain

A study testing Classification Based Cognitive Functional Therapy in people with Chronic Low Back Pain, run by KU Leuven at 1 site in Belgium.

Completed

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

Official record
Search all trials

Trial summary

A series of case-studies to explore the efficacy of classification based cognitive functional physiotherapy according to the classification system proposed by Peter O'Sullivan in specific nursing population with non specific chronic low back pain. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Classification Based Cognitive Functional Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteBelgium
Study dates
Dec 2012to Mar 2016
Phase
Interventional
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Low Back Pain (LBP) with/without referred pain in buttock/thigh for > 3 months, including the four weeks prior to testing
  • LBP is primarily localised from T12 to gluteal folds
  • mechanical provocation of LBP with postures, movement and activities
  • average pain intensity in the past week Numerical Rating Scale (NRS) >/= 1/10
  • Disability (ODI) >/=2%
  • willingness to sign the informed consent

Who cannot join

  • specific spinal pathology
  • presence of red flags
  • previous lumbar spinal surgery
  • pregnancy
  • diagnosed psychiatric disorder - somatisation
  • radicular pain with positive neural tissue provocation test
  • widespread non-specific pain disorder (no primary LBP focus)
  • specific diagnoses: active rheumatologic disease, progressive neurological disease, serious cardiac or other internal medical condition, malignant basic diseases, acute traumas, infections, or acute vascular catastrophes

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Lindelo

    Lille, Antwerpen, 2275

Other trials in Belgium

About this study

Official title: Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain - a Series of Case-controls

A series of case-studies to explore the efficacy of classification based cognitive functional physiotherapy according to the classification system proposed by Peter O'Sullivan in specific nursing population with non specific chronic low back pain.

The investigators hypothesis was that treatment targeting the mechanisms behind the problem from a multidimensional perspective would be effective to reduce pain, disability and sick-leave.

Read the detailed description

Low back pain (LBP) is a common, recalcitrant and costly health problem, which limits patients' daily activities. In 85% of the cases, LBP is classified as 'non-specific', which means there is no clear underlying patho-anatomical/radiological abnormality. This subgroup often gives rise to a chronic fluctuating problem. Although most cases of LBP resolve within 8 to 12 weeks, it may become chronic in up to 15% of patients. LBP constitutes an enormous and growing medical and socio-economical problem for the modern society. Nursing has been identified amongst the top professions at risk for occupational LBP, with lifetime prevalence between 66%-82%. The impact of LBP for nurses includes time off work, increased risk of chronicity, associated personal and economic costs and reduced nursing workforce efficiency.

Non Specific Chronic Low Back Pain (NSCLBP) is widely viewed as a multifactorial biopsychosocial pain syndrome. It has been proposed by several authors that NSCLBP represents a vicious cycle associated with different combinations of maladaptive; cognitive (negative beliefs, fear avoidance behaviours, catastrophising, depression, stress, lack of pacing and coping), physical (pain provocative postures, movement patterns and pain behaviours) and lifestyle (inactivity, rest) behaviours that act to promote pain and disability. However a recent systematic review suggests that this change in paradigm and the investigators new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. In line with this paradigm shift a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their underlying pain mechanism. Enabling a classification based interventions targetting the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

Being tested
Classification Based Cognitive Functional Therapy
Keywords
Pain, Back Pain, Low Back Pain, Chronic Low Back Pain, Cognitive Functional Therapy, Intervention, Subclassification, Multidimensional
Medical subject headings
Pain, Back Pain, Low Back Pain

What participants receive

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

  • Classification Based Cognitive Functional TherapyOther

    Also called cognitive functional therapy

    A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation. This subclassification is the base for matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder. The intervention is called 'cognitive functional therapy' as it directly challenges these behaviours in a functionally specific and graduated manner.

Study groups in NCT01882686
Study groupRoleWhat they receive
Classification Based Cognitive Functional TherapyExperimentalNot described
Receives: Other: Classification Based Cognitive Functional Therapy

What is being measured

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

  1. Change from baseline in pain

    Pain was assessed using a numerical pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst imaginable pain)

    Measured: 3, 6, 9 and 12 months

  2. Change from baseline in disability

    Disability was measured using the Oswestry Disability Index (ODI)

    Measured: 3, 6, 9 months, 1 and 3 year

Secondary outcomes (13)

  1. Change from baseline in Beliefs about LBP

    Back Beliefs Questionnaire (BBQ)

    Measured: 3, 6, 9 and 12 months

  2. Change from baseline in Chance of long-term disability and failure to return to work

    Tha Acute Low Back Pain Screening Questionnaire (Dutch version of the Ørebro Pain Screening Questionnaire) is a 'yellow flag' screening tool that predicts long-term disability and failure to return to work due to personal and environmental factors.

    Measured: 3, 6, 9 and 12 months

  3. Change from baseline in Physical activity

    Baecke questionnaire

    Measured: 3, 6, 9 and 12 months

  4. Change from baseline in Sleep problems

    Insomnia Severity Index (ISI)

    Measured: 3, 6, 9 and 12 months

  5. Change from baseline in Depression, anxiety and stress

    Depression Anxiety and Stress scale (DASS-21)

    Measured: 3, 6, 9 and 12 months

  6. Change from baseline in Self-efficacy, coping

    Pain Self-Efficacy Questionnaire (PSEQ)

    Measured: 3, 6, 9 and 12 months

  7. Change from baseline in Fear-avoidance / kinesiophobia

    Tampa Scale of Kinesiophobia (TSK-17)

    Measured: 3, 6, 9 and 12 months

  8. Change from baseline in Pain catastrophizing

    Pain Catastrophizing Scale (PCS)

    Measured: 3, 6, 9 and 12 months

  9. Change from baseline in Psychosocial job aspects

    The Job Content Questionnaire (JCQ) is a tool for psychosocial job assessment.

    Measured: 3, 6, 9 and 12 months

  10. Change from baseline in Lower Lumbar spine Kinematics

    Lower Lumbar kinematics of the spine were measured with the BodyGuard (sels-instruments nv). This is a remote measuring system.

    Measured: 3, 6, 9 and 12 months

  11. Patient satisfaction of the intervention

    Patients' Global Impression of Change (PGIC) scale

    Measured: 3, 6, 9 and 12 months

  12. Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)

    The Start Back Screening Tool is used to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. The tool helps to group patients into 3 categories of risk of poor outcome (persistent disabling symptoms) - low, medium, and high-risk.

    Measured: 3, 6, 9 and 12 months

  13. Change from baseline in Psychosocial aspects of work

    Psychosocial Aspects of Work Questionnaire (PAWQ)

    Measured: 3, 6, 9 and 12 months

Timeline

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

  1. First posted20 Jun 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionMay 2014
  4. Study completionMar 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01882686
Sponsor's protocol ID
S54606
Status last verified
Jan 2019
First submitted
12 Jun 2013
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain. 2013 Jul;17(6):916-28. doi: 10.1002/j.1532-2149.2012.00252.x. Epub 2012 Dec 4.

    PubMed 23208945

  • O'Sullivan P. Diagnosis and classification of chronic low back pain disorders: maladaptive movement and motor control impairments as underlying mechanism. Man Ther. 2005 Nov;10(4):242-55. doi: 10.1016/j.math.2005.07.001. Epub 2005 Sep 9.

    PubMed 16154380

  • Dankaerts W, O'Sullivan P. The validity of O'Sullivan's classification system (CS) for a sub-group of NS-CLBP with motor control impairment (MCI): overview of a series of studies and review of the literature. Man Ther. 2011 Feb;16(1):9-14. doi: 10.1016/j.math.2010.10.006. Epub 2010 Nov 20.

    PubMed 21094624

  • Van Hoof W, O'Sullivan K, Verschueren S, O'Sullivan P, Dankaerts W. Evaluation of Absenteeism, Pain, and Disability in Nurses With Persistent Low Back Pain Following Cognitive Functional Therapy: A Case Series Pilot Study With 3-Year Follow-Up. Phys Ther. 2021 Jan 4;101(1):pzaa164. doi: 10.1093/ptj/pzaa164.

    PubMed 32949123

Questions about this trial

What is this clinical trial studying?

A study testing Classification Based Cognitive Functional Therapy in people with Chronic Low Back Pain, run by KU Leuven at 1 site in Belgium.

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 6 inclusion and 8 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

Change from baseline in pain (time frame: 3, 6, 9 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01882686, which also lists 4 linked publications.

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 4 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in