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

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ClinicalTrials.gov Identifier: NCT02145728
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Curtin University
KU Leuven
Mayo General Hospital, Ireland
Health Service Executive, Ireland
Information provided by (Responsible Party):
University of Limerick

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Individual Cognitive Functional Therapy Behavioral: Group Exercise Classes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial
Actual Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145728


Locations
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Ireland
Ballina Primary Care Centre
Mayo, Connacht, Ireland, 0000
Claremorris Primary Care Centre
Mayo, Connacht, Ireland, 0000
Mayo General Hospital
Mayo, Connacht, Ireland, 0000
Sponsors and Collaborators
University of Limerick
Curtin University
KU Leuven
Mayo General Hospital, Ireland
Health Service Executive, Ireland
Investigators
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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 of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Limerick
ClinicalTrials.gov Identifier: NCT02145728    
Other Study ID Numbers: MGH-14-UL
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Keywords provided by University of Limerick:
Non-specific chronic low back pain
Cognitive functional therapy
Exercise classes
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations