Clinical trial NCT02145728: The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain
Official title: The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Non-specific chronic low back pain
Cognitive functional therapy
Exercise classes
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Curtin University
name: KU Leuven
name: Mayo General Hospital, Ireland
name: Health Service Executive, Ireland
First posted: 2014-05-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.

Detailed description: A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used. Patient with non- specific chronic low back pain will be assessed for eligibility. The patients fitting the inclusion criteria will be randomised to receive either the individual CFT or the group classes consisting of education and exercise. Participants' pain, disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general health, stress levels, as well as number and cost of treatments will be evaluated using a range of outcome measures at the start and on completion of the treatment. Patients will receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months after treatment to reassess clinical outcomes. If a participant does not respond to follow-up, they will be telephoned to ask if they wish to complete the questionnaires.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 75
* Chronic low back pain greater than 6 months duration
* Score greater than 14% for disability on Oswestry Disability Index (ODI)
* Independently mobile (with or without aids), to be capable of participating in a rehabilitation programme

Exclusion Criteria:

* Primary pain area is not the lumbar spine (from T12-buttocks)
* Leg pain as the primary problem (nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess/central or spinal stenosis with primary leg pain)
* \<6 months post lumbar spine or lower limb or abdominal surgery
* Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
* Pregnancy
* Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)
* Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
* Unstable cardiac conditions
* Red flag disorders like malignancy/cancer, acute traumas like fracture (\<6 months ago) or infection, spinal cord compression/cauda equina

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Secondary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Socio-economic Conditions Index
timeFrame: Baseline
measure: Back Pain Beliefs Questionnaire
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Pain Self- Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Subjective Health Complaints Inventory (SHC)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Nordic Musculoskeletal Screening Questionnaire
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Stress subscale of the Depression, Anxiety and Stress scale (DASS 21)
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Patient Satisfaction Questionnaire
timeFrame: At 8-14 weeks
measure: Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)
timeFrame: Measured at baseline
measure: Medication usage
timeFrame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
measure: Economic evaluation
timeFrame: 6, 12 and 36 months
measure: Level of co-interventions
timeFrame: Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months
Other outcomes:
Locations:
city: Mayo
country: Ireland
facility: Ballina Primary Care Centre
state: Connacht
city: Mayo
country: Ireland
facility: Claremorris Primary Care Centre
state: Connacht
city: Mayo
country: Ireland
facility: Mayo General Hospital
state: Connacht
Study officials:
affiliation: University of Limerick
name: Dr Kieran O' Sullivan, PhD
role: STUDY_DIRECTOR
affiliation: University of Limerick
name: Mary O'Keeffe, BSc Physio
role: PRINCIPAL_INVESTIGATOR
affiliation: Curtin University
name: Prof. Peter O'Sullivan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Limerick
name: Dr Norelee Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Prof. Wim Dankaerts, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012 Mar;46(4):224-7. doi: 10.1136/bjsm.2010.081638. Epub 2011 Aug 4. No abstract available.
citation: 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.
citation: O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
citation: O'Keeffe M, Purtill H, Kennedy N, O'Sullivan P, Dankaerts W, Tighe A, Allworthy L, Dolan L, Bargary N, O'Sullivan K. Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015 Jun 1;5(6):e007156. doi: 10.1136/bmjopen-2014-007156.