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

The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Individual Cognitive Functional Therapy; Behavioral: Group Exercise Classes

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.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Connacht
    • Mayo, Connacht, Ireland, 0000
      • Ballina Primary Care Centre
    • Mayo, Connacht, Ireland, 0000
      • Claremorris Primary Care Centre
    • Mayo, Connacht, Ireland, 0000
      • Mayo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual Cognitive Functional Therapy; 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; 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.
Active Comparator: Group Exercise Classes; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale (NRS)	Measures pain intensity	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Socio-economic Conditions Index	Measures socio-economic status	Baseline
Back Pain Beliefs Questionnaire	Assess a person's beliefs about their back pain	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ)	Assesses a person's level of fear-avoidance beliefs regarding physical activities.	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)	Assesses level of pain catastrophizing.	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Pain Self- Efficacy Questionnaire (PSEQ)	Assesses level of pain self-efficacy	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Subjective Health Complaints Inventory (SHC)	Assess level of subjective health complaints	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Nordic Musculoskeletal Screening Questionnaire	Assesses areas of bodily pain	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Stress subscale of the Depression, Anxiety and Stress scale (DASS 21)	Assesses patient's stress levels.	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Patient Satisfaction Questionnaire	Assesses patient satisfaction	At 8-14 weeks
Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)	Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity.	Measured at baseline
Medication usage	To assess changes in levels of medication used.	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Economic evaluation	Assesses direct and indirect costs of both treatment arms to see which is more cost-effective.	6, 12 and 36 months
Level of co-interventions	Assesses the number/type of healthcare services availed of throughout the intervention period.	Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months

Collaborators and Investigators

• Sponsor: University of Limerick
• Collaborators: KU Leuven; Curtin University; Health Service Executive, Ireland; Mayo General Hospital, Ireland
• Investigators: Study Director: Dr Kieran O' Sullivan, PhD, University of Limerick; Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Non-specific chronic low back pain; Cognitive functional therapy; Exercise classes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: MGH-14-UL