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

NCT01129817 | Completed DMC

• 1 other identifier: 250.05.
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Cognitive Functional Therapy; Manual Therapy and Exercise; Chronic Low Back Pain; Randomized Controlled Trial; Subclassification

Outcome Measures

Primary Outcomes (2)

• Pain

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

  12 months

• Disability

  Disability measured by Oswestry Disability Index.

  12 months

Secondary Outcomes (4)

• Well being

  12 months

• Beliefs

  12 months

• Screening questionnaire

  12 months

• Patient satisfaction

  12 months

Study Arms (2)

Cognitive Functional Therapy

EXPERIMENTAL

Other: Cognitive Functional Therapy

Manual Therapy and Exercise

ACTIVE COMPARATOR

Other: Manual therapy and exercise

Interventions

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.

Cognitive Functional Therapy

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.

Manual Therapy and Exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

Related Publications (1)

• 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.

  PMID: 30974479 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kjartan Vibe Fersum, PhD Student

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 25, 2010
• Study Start: March 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 25, 2010

Record last verified: 2010-05

Locations

NO (1)