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

University of Limerick

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Behavioral: Individual Cognitive Functional Therapy; Behavioral: Group Exercise Classes

Study type: Interventional

Funder types: Other

Identifiers

NCT02145728

MGH-14-UL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Individual Cognitive Functional Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Individual Cognitive Functional Therapy

Group Exercise Classes

Active Comparator group

Description:

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.

Treatment:

Behavioral: Group Exercise Classes