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Completed

NCT Number: NCT02145728

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ballina Primary Care Centre, Mayo, Connacht, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Oswestry Disability Index (ODI)

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

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

Secondary outcomes

  1. Numerical rating scale (NRS)

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

    Measures pain intensity

  2. Socio-economic Conditions Index

    Time frame: Baseline

    Measures socio-economic status

  3. Back Pain Beliefs Questionnaire

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

    Assess a person's beliefs about their back pain

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

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

    Assesses a person's level of fear-avoidance beliefs regarding physical activities.

  5. The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)

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

    Assesses level of pain catastrophizing.

  6. Pain Self- Efficacy Questionnaire (PSEQ)

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

    Assesses level of pain self-efficacy

  7. Subjective Health Complaints Inventory (SHC)

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

    Assess level of subjective health complaints

  8. Nordic Musculoskeletal Screening Questionnaire

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

    Assesses areas of bodily pain

  9. Stress subscale of the Depression, Anxiety and Stress scale (DASS 21)

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

    Assesses patient's stress levels.

  10. Patient Satisfaction Questionnaire

    Time frame: At 8-14 weeks

    Assesses patient satisfaction

  11. Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)

    Time frame: Measured at baseline

    Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity.

  12. Medication usage

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

    To assess changes in levels of medication used.

  13. Economic evaluation

    Time frame: 6, 12 and 36 months

    Assesses direct and indirect costs of both treatment arms to see which is more cost-effective.

  14. Level of co-interventions

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

    Assesses the number/type of healthcare services availed of throughout the intervention period.

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

  • Curtin University
  • Health Service Executive, Ireland
  • KU Leuven
  • Mayo General Hospital, Ireland

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
May 23, 2014
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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