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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145728
• Other study ID #: MGH-14-UL
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	Ballina Primary Care Centre	Mayo	Connacht
Ireland	Claremorris Primary Care Centre	Mayo	Connacht
Ireland	Mayo General Hospital	Mayo	Connacht

Sponsors (5)

Lead Sponsor	Collaborator
University of Limerick	Curtin University, Health Service Executive, Ireland, KU Leuven, Mayo General Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. — View Citation

Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvåle 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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical rating scale (NRS)	Measures pain intensity	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Secondary	Socio-economic Conditions Index	Measures socio-economic status	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain Self- Efficacy Questionnaire (PSEQ)	Assesses level of pain self-efficacy	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Secondary	Subjective Health Complaints Inventory (SHC)	Assess level of subjective health complaints	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Secondary	Nordic Musculoskeletal Screening Questionnaire	Assesses areas of bodily pain	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Secondary	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
Secondary	Patient Satisfaction Questionnaire	Assesses patient satisfaction	At 8-14 weeks
Secondary	Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)	Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity.	Measured at baseline
Secondary	Medication usage	To assess changes in levels of medication used.	Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Secondary	Economic evaluation	Assesses direct and indirect costs of both treatment arms to see which is more cost-effective.	6, 12 and 36 months
Secondary	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