The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain

NCT02145728 | Completed DMC

• 1 other identifier: MGH-14-UL
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Low Back Pain

Keywords

Non-specific chronic low back pain; Cognitive functional therapy; Exercise classes

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI)

  Used to assess change in disability levels over the course of the trial and follow-up

  Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

Secondary Outcomes (14)

• Numerical rating scale (NRS)

  Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

• Socio-economic Conditions Index

  Baseline

• Back Pain Beliefs Questionnaire

  Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

• Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ)

  Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

• The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)

  Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

Study Arms (2)

Individual Cognitive Functional Therapy

EXPERIMENTAL

The intervention being tested has four main components: (1) a cognitive component, for each patient, their vicious cycle of pain will outlined in a diagram based on their findings from the examination and the Orebro Musculoskeletal Pain Screening Questionnaire; (2) specific movement exercises designed to normalize maladaptive movement behaviours; (3) targeted functional integration of activities in their daily life previously, reported to be avoided or provocative by the patient; and (4) a physical activity and lifestyle programme.

Behavioral: Individual Cognitive Functional Therapy

Group Exercise Classes

ACTIVE COMPARATOR

6 classes will take place in total. The class has 3 components each week. First, a 30 minute talk and discussion on chronic pain, and some tips for participants. Second, a 40 minute exercise circuit, involving aerobic exercise, and gentle stretching and strengthening exercises. Finally, a 5 minute relaxation/mindfulness session will take place at the end. The total time involved is approximately 1 hour and 15 minutes.

Behavioral: Group Exercise Classes

Interventions

Individual Cognitive Functional Therapy BEHAVIORAL

Cognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem.

Individual Cognitive Functional Therapy

Group Exercise Classes BEHAVIORAL

Each class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.

Group Exercise Classes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Limerick: lead
• Curtin University: collaborator
• KU Leuven: collaborator
• Mayo General Hospital, Ireland: collaborator
• Health Service Executive, Ireland: collaborator

Study Sites (3)

Ballina Primary Care Centre

Mayo, Connacht, 0000, Ireland

Location

Claremorris Primary Care Centre

Mayo, Connacht, 0000, Ireland

Location

Mayo General Hospital

Mayo, Connacht, 0000, Ireland

Location

Related Publications (4)

• 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.

  PMID: 21821612 BACKGROUND

• 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 RESULT

• 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.

  PMID: 31630089 DERIVED

• 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.

  PMID: 26033941 DERIVED

Study Officials

• Dr Kieran O' Sullivan, PhD

  University of Limerick

  STUDY DIRECTOR

• Mary O'Keeffe, BSc Physio

  University of Limerick

  PRINCIPAL INVESTIGATOR

• Prof. Peter O'Sullivan, Professor

  Curtin University

  PRINCIPAL INVESTIGATOR

• Dr Norelee Kennedy, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

• Prof. Wim Dankaerts, Professor

  KU Leuven

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 23, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

IE (3)