Clinical trial NCT03221439: Cognitive Functional Therapy for Chronic Low Back Pain
Official title: Cognitive Functional Therapy (CFT) Compared With a Combined Manual Therapy and Motor Control Exercise in Patients With Non-specific Chronic Low Back Pain: a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Back Pain
Pain
Signs and Symptoms
Neuromuscular Manifestations
Keywords: back pain
physiotherapy
exercise therapy
cognitive functional therapy
low back pain
backache
lower back pain
lumbago
multidimensional
biopsychosocial
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2017-07-18
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, immediately after the end of the intervention (12 weeks), as in 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by two physical therapists that attended twice the CFT workshops with two of the tutors of the method. They completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in MT-EX group will be treated by two physical therapists with more than 8 years of clinical experience in manual therapy and motor control exercises.
Primary purpose: TREATMENT

Brief summary: There is evidence, of a single randomized controlled trial, that CFT is better than combined manual therapy and motor control exercise for chronic low back pain. However, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. It is important to replicate this study through a randomized clinical trial with similar objectives in another domain, but correcting these methodological shortcomings. Therefore, the aim of the study is to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back pain.

Detailed description: One hundred and forty eight patients with chronic low back pain from two outpatient physiotherapy clinics in Brazil will be randomized to receive either Cognitive Functional Therapy or combined Manual Therapy and Motor Control Exercises. Intervention: 4-10 sessions of CFT. Control: 4-10 sessions of combined Manual Therapy and Motor Control Exercises. Measurements: Clinical outcomes will be assessed at the baseline, 3 months, 6 months and 12 months after randomization. Analysis: Intention-to-treat analysis will be performed, and linear mixed models will be calculated to evaluate the effect of the intervention. Non-specific predictors, moderators and mediators of outcome will also be analysed. Discussion: This study will investigate whether the results of the first CFT clinical trial can be replicated. In addition, the results will contribute to a better understanding of the efficacy of the CFT approach.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years
* Low back pain for more than 3 months
* Disability score of 14% or more on the Oswestry Disability Index (ODI)
* Being able to walk independently with or without support
* Understand Portuguese well enough to be able to fill in the questionnaires

Exclusion Criteria:

* Main pain area is not the lumbar spine (from T12 to buttocks)
* Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
* Less than 6 months after lumbar spine, lower limb or abdomen surgery
* Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3 months
* Pregnancy
* Inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Scheuermann's disease)

Primary outcomes:
measure: Pain intensity
timeFrame: 3 months after randomization
measure: Disability associated to low back pain
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Global impression of recovery
timeFrame: 3, 6 and 12 months after randomization
measure: Pain intensity
timeFrame: 6 and 12 months after randomization
measure: Disability associated to low back pain
timeFrame: 6 and 12 months after randomization
measure: Patient Satisfaction
timeFrame: 3, 6 and 12 months after randomization
Other outcomes:
measure: Anxiety (mediator of outcome)
timeFrame: 3 and 6 months after randomization
measure: Social isolation (mediator of outcome)
timeFrame: 3 and 6 months after randomization
measure: Catastrophization (mediator of outcome)
timeFrame: 3 and 6 months after randomization
measure: Depression (mediator of outcome)
timeFrame: 3 and 6 months after randomization
measure: Fear of movement (mediator of outcome)
timeFrame: 3 and 6 months after randomization
measure: Stress (mediator of outcome)
timeFrame: 3 and 6 months after randomization
measure: Sleep (mediator of outcome)
timeFrame: 3 and 6 months after randomization
Locations:
city: Rio de Janeiro
country: Brazil
facility: Centro Universitário Augusto Motta
Study officials:
affiliation: Centro Universitário Augusto Motta, UNISUAM
name: Ney Meziat-Filho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
citation: 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. No abstract available.
citation: Goyal M, Haythornthwaite JA. Is It Time to Make Mind-Body Approaches Available for Chronic Low Back Pain? JAMA. 2016 Mar 22-29;315(12):1236-7. doi: 10.1001/jama.2016.2437. No abstract available.
citation: Menke JM. Do manual therapies help low back pain? A comparative effectiveness meta-analysis. Spine (Phila Pa 1976). 2014 Apr 1;39(7):E463-72. doi: 10.1097/BRS.0000000000000230.
citation: Sveinsdottir V, Eriksen HR, Reme SE. Assessing the role of cognitive behavioral therapy in the management of chronic nonspecific back pain. J Pain Res. 2012;5:371-80. doi: 10.2147/JPR.S25330. Epub 2012 Oct 11.
citation: Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
citation: O'Keeffe M, Purtill H, Kennedy N, O'Sullivan P, Dankaerts W, Tighe A, Allworthy L, Dolan L, Bargary N, O'Sullivan K. Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015 Jun 1;5(6):e007156. doi: 10.1136/bmjopen-2014-007156.
citation: Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale 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.1532-2149.2012.00252.x. Epub 2012 Dec 4.
citation: Meziat Filho N. Changing beliefs for changing movement and pain: Classification-based cognitive functional therapy (CB-CFT) for chronic non-specific low back pain. Man Ther. 2016 Feb;21:303-6. doi: 10.1016/j.math.2015.04.013. Epub 2015 Apr 16.
citation: Meziat Filho N, Mendonca R, Nogueira LA. Lack of confidence in the lower limb: Cognitive Functional Therapy (CFT) for a unilateral loading impairment in chronic non-specific low back pain. Case report. Man Ther. 2016 Sep;25:104-8. doi: 10.1016/j.math.2016.02.007. Epub 2016 Mar 12.
citation: Kent P, Mirkhil S, Keating J, Buchbinder R, Manniche C, Albert HB. The concurrent validity of brief screening questions for anxiety, depression, social isolation, catastrophization, and fear of movement in people with low back pain. Clin J Pain. 2014 Jun;30(6):479-89. doi: 10.1097/AJP.0000000000000010.
citation: Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.