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Completed

NCT Number: NCT01129817

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

A randomized controlled trial of the efficacy of classification based cognitive functional physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual therapy and exercise in patients with non specific chronic low back pain.

The investigators hypothesis was that treatment targeted at the mechanism behind the problem from a multidimensional perspective would be superior to traditional treatment.

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Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Hordaland, 5018, Norway

About this study

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 our new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. line with this shift in paradigm a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation of. with matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients with non-specific LBP for more that 8 weeks duration
  • mechanical provocation of pain with postures, movement and activities
  • localised pain in the area from T12 to gluteal folds
  • moderate ongoing LBP with a VAS > 2/10
  • disability had to be higher than 14% on Oswestry Disability Index

Exclusion criteria

  • sick listed for more than 4 months continuous duration
  • acute exacerbation of LBP
  • radicular pain with positive neural tissue provocation test
  • any low limb surgery on the last 3 months
  • surgery involving the lumbar spine (fusion)
  • pregnancy
  • psychiatric disorders - somatisation
  • dominant psycho-social problems
  • 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 catastrophies

Treatment and study plan

Cognitive Functional Therapy

Other

A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation with 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.

Manual Therapy and Exercise

Other

Patients in this group was treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and was designed to be consistent with best current manual therapy practice in Norway. The particular dose and techniques were at the discretion of the treating therapist, based on each participant's objective and physical examination findings. In addition most of the patients in this group was given exercises or a home exercise program.

Primary outcomes

  1. Pain

    Time frame: 12 months

    Pain was assessed using a pain numerical rating scale from 0 to 10

  2. Disability

    Time frame: 12 months

    Disability measured by Oswestry Disability Index.

Secondary outcomes

  1. Well being

    Time frame: 12 months

    Hopkins Symptoms Checklist.

  2. Beliefs

    Time frame: 12 months

    Fear Avoidance Beliefs Questionnaire

  3. Screening questionnaire

    Time frame: 12 months

    The Ørebro Pain Screening Questionnaire

  4. Patient satisfaction

    Time frame: 12 months

    patient satisfaction. 5 items scale

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Norwegian Fund for Postgraduate Training in Physiotherapy

Registry information

Official study title

Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 25, 2010
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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