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

NCT01882686 | Completed

• 1 other identifier: S54606
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Low Back Pain

Keywords

Pain; Back Pain; Low Back Pain; Chronic Low Back Pain; Cognitive Functional Therapy; Intervention; Subclassification; Multidimensional

Outcome Measures

Primary Outcomes (2)

• 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)

  3, 6, 9 and 12 months

• Change from baseline in disability

  Disability was measured using the Oswestry Disability Index (ODI)

  3, 6, 9 months, 1 and 3 year

Secondary Outcomes (13)

• Change from baseline in Beliefs about LBP

  3, 6, 9 and 12 months

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

  3, 6, 9 and 12 months

• Change from baseline in Physical activity

  3, 6, 9 and 12 months

• Change from baseline in Sleep problems

  3, 6, 9 and 12 months

• Change from baseline in Depression, anxiety and stress

  3, 6, 9 and 12 months

Study Arms (1)

Classification Based Cognitive Functional Therapy

EXPERIMENTAL

Other: Classification Based Cognitive Functional Therapy

Interventions

Classification Based Cognitive Functional Therapy OTHER

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.

Also known as: cognitive functional therapy

Classification Based Cognitive Functional Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• European Social Fund: collaborator

Study Sites (1)

Lindelo

Lille, Antwerpen, 2275, Belgium

Location

Related Publications (4)

• 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.

  PMID: 23208945 BACKGROUND

• 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.

  PMID: 16154380 BACKGROUND

• 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.

  PMID: 21094624 BACKGROUND

• 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.

  PMID: 32949123 DERIVED

MeSH Terms

Conditions

Pain; Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wim Dankaerts

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 20, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: March 1, 2016
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

BE (1)