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

University of Limerick208 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

208

Conditions

Chronic Low Back Pain

Interventions

Individual Cognitive Functional TherapyBEHAVIORAL

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 ClassesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Ballina Primary Care Centre

Mayo, Connacht, Ireland

Claremorris Primary Care Centre

Mayo, Connacht, Ireland

Mayo General Hospital

Mayo, Connacht, Ireland