Cognitive Functional Therapy for Chronic Low Back Pain
Condition: Low Back Pain; Back Pain; Pain; Signs and Symptoms; Neuromuscular Manifestations
MeSH terms: Neuromuscular Manifestations; Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Cognitive Functional Therapy; Manual Therapy and Motor Control Exercise
Intervention type(s): Behavioral; Other
Intervention description(s): There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability.
Specific Functional training is designed to normalize maladaptive or provocative movement and posture.
Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting)
Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies; According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with joint mobilization or manipulation techniques applied to the lower back or pelvis. The active exercises will involve isolated contractions of the deep abdominal and multifidus muscles in different functional positions. Most patients in this group will receive exercises to perform at home. This will include general exercise or motor control exercise, but not related to CFT.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; physiotherapy; exercise therapy; cognitive functional therapy; low back pain; backache; lower back pain; lumbago; multidimensional; biopsychosocial