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

NCT ID: NCT01129817

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Functional Therapy

Group Type: EXPERIMENTAL

Cognitive Functional Therapy

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Manual therapy and exercise

Intervention Type: 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.

Interventions

Cognitive Functional Therapy

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.

Intervention Type: OTHER

Manual therapy and exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

University of Bergen

Principal Investigators

Kjartan Vibe Fersum, PhD Student

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

University of Bergen

Bergen, Hordaland, Norway

Countries

Norway

References

Vibe Fersum K, Smith A, Kvale A, Skouen JS, O'Sullivan P. Cognitive functional therapy in patients with non-specific chronic low back pain-a randomized controlled trial 3-year follow-up. Eur J Pain. 2019 Sep;23(8):1416-1424. doi: 10.1002/ejp.1399. Epub 2019 May 14.

Reference Type: DERIVED

PMID: 30974479 (View on PubMed)

Other Identifiers

250.05.

Identifier Type: -

Identifier Source: org_study_id