Cognitive Functional Therapy Compared With Sham-treatment for Low Back Pain

Overview

Low back pain is an urgent global public health concern. There is strong evidence that this condition is associated with a complex interaction of biopsychosocial factors. Cognitive Functional Therapy (CFT) is an innovative, patient-centered behavioral intervention that addresses multiple modifiable aspects of chronic low back pain (CLBP). Promising results have been demonstrated by randomized clinical trials, however, it is not yet known whether this approach is superior to placebo. The aim of the current study is to investigate the efficacy of Cognitive Functional Therapy (CFT) compared with a sham-intervention for pain intensity and disability at the end of the treatment and at 3-month follow-up in patients with non-specific chronic low back pain (CLBP). This study is a randomized clinical trial in which 152 (18 – 60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive: (1) CFT intervention or (2) sham-intervention. The experimental group will receive individualised CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of participants. The sham group will attend six sessions: consisted of 30 minutes of photobiomodulation using a detuned device and more 15 minutes of talking about neutral topics. Participants will be assessed preintervention, postintervention and after six months after randomization. Patients from both groups also will receive an educational booklet. The primary outcomes will be pain intensity and disability immediate after the treatment and at 3-month follow-up. The secondary outcomes will be: pain intensity and disability at 6-month follow-up, exercise adherence, global perceived effect of improvement and functioning at 3- and 6-month follow-up. The patients will be blinded to treatment administrated (active vs. sham). The between-group differences (effects of treatment) and their respective 95% confidence intervals will be calculated by constructing linear mixed models. Treatment effect for the primary and secondary outcomes will be estimated using mixed linear models, taking into account the correlation within individual.

Full Title of Study: “Efficacy of the Cognitive Functional Therapy (CFT) in Patients With Chronic Nonspecific Low Back Pain: a Study Protocol for a Randomized Sham-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2023

Detailed Description

The aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention, comprised of photobiomodulation using a detuned device + talking about neutral topics, for pain intensity and disability at the end of the treatment and at 3-month follow-up. The secondary aims will be to investigate the effect of CFT for pain intensity and disability at 6-month follow-up, as well as the effect of the active treatment on exercise adherence, global perceived effect of improvement, functioning and therapeutic alliance at 3- and 6-month follow-up. The study was submitted to and approved by the ethics committee for research involving human subjects of the Ribeirão Preto Medical School (Ethics Committee Board from Centro Saúde Escola Cuaibá) of the University of São Paulo (HCFMRP CAE number: 26780619.0.0000.5414). This study will be a sham-controlled randomized clinical trial (RCT). The sample will be comprised of 152 participants (both genders) with non-specific CLBP who will be referred to the physiotherapy outpatient clinic from the Centro Saúde Escola Cuiabá of Ribeirão Preto Medical School – University of São Paulo (Brazil). Patients will be informed that this study will involve a sham intervention arm (fake intervention in which an inert treatment will be provided but it still can result in positive outcomes due to its psychological effects) vs. an active treatment arm, but the nature of the sham will not be elucidated (equipment detuned). After this initial assessment, participants will be randomly assigned using block randomization by simple computerized procedures to one of the two treatment groups through the use of cards previously placed in opaque sealed envelopes: i) CFT group or ii) Sham group. As a strategy to control for the treatment fidelity on both arms of the study, we will adopt the framework developed by the NIH Behaviour Change Consortium (BCC). To control for the "Intervention Delivery", the time of therapist-patient interaction, number of sessions and the different components of the intervention administered (e.g.: in the sham-group, the time administering the sham photobiomodulation and the time spent with neutral talking), as well as video recordings during the pilot study and along the trial will be registered. Also, regular meetings to discuss the clinical cases will be performed. Furthermore, the "Intervention receipt" will be assessed in two different manners: i) on the completion of the study, each participant will be submitted to a manipulation check and they will be asked about the group they think they were at and ii) patients in both groups will be invited to summarize at the beginning of each session how the treatment impact their lives. Despite it is a sham-controlled RCT, considering the differences in the interventions administered in both study arms, it will not be possible to blind the therapists, however, patients will be blinded to randomized interventions. The assessor and the participants will not have access to what type of treatment the participant will be given. To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.

Interventions

  • Behavioral: Cognitive Functional Therapy (CFT)
    • Cognitive functional therapy (CFT) is an intervention that deals with potentially modifiable multidimensional aspects of pain (e.g. provocative cognitive, movement and lifestyle behaviours). Treatment with CFT will be individualised, the physiotherapist will listen to the complete patient pain history and the intervention will be focused on individual needs. A detailed examination will be crucial in identifying the modifiable multidimensional mediators of pain and disability (provocative cognitive, pain, movement and lifestyle behaviors) of each participant.
  • Other: Sham intervention
    • Due to the impossibility of applying placebo exercise, the control intervention in this study will be based on successful reports of placebo intervention in patients with chronic low back pain in the literature (Placebo photobiomodulation + neutral talking control)

Arms, Groups and Cohorts

  • Experimental: Cognitive Functional Therapy (CFT) Group
    • There will be 3 main components in the intervention: Making sense of pain: the cognitive component will focus on identifying the factors that contribute to pain during examination. This will include discussion on the multidimensional nature of persistent pain, individual beliefs, and how emotions and behaviours regarding movement and lifestyle can reinforce a vicious cycle of pain and disability. Controlled exposure: specific functional training is designed to normalise maladaptive or provocative movement and posture. functional integration is directed at activities of daily life that are avoided by the patient. This will vary among individuals but should include basic activities such as rolling in bed, sitting, sitting to standing, walking, bending and lifting. Lifestyle change: Physical activity and lifestyle. Patients will be advised to gradually increase physical activity based on their preference, while also focusing on sleep hygiene, stress and management strategies.
  • Sham Comparator: Sham intervention
    • Patients allocated to the placebo group will be treated with detuned photobiomodulation device using a handheld probe (904Nm Ibramed Infrared – no-visible beam), without any emission of therapeutic dose. Three central sites in the space between T11/T12, L2/L3 and L5/S1 and two points laterally positioned in each anatomical level will be submitted to fake stimulation. Three minutes of fake stimulation will be administered, summing up 27 minutes. In addition, a neutral talking control therapy of at least 15 minutes will be provided to patients in the sham group in each session. Maladaptive beliefs will not be challenged; however, the therapists will be trained to show interest and warmth, empathy and encouraging participants to discuss neutral topics such as hobbies, sports, and current affairs. No advice or problem solving will be given, and any attempt to talk about emotional issues will be kindly discouraged and the talking will be redirect to neutral tropics.

Clinical Trial Outcome Measures

Primary Measures

  • Pain intensity: Brazilian version of the 11-point Numerical Pain Rating Scale (NPRS)
    • Time Frame: 3 months
    • This will be measured using the Brazilian version of the 11-point Numerical Pain Rating Scale (NPRS).The NPRS scale goes from 0 to 10, where 0 is “no pain” and 10 is “the worst pain imaginable”. Participants will be asked to assess their pain levels based on the last seven days.
  • Disability associated with low back pain
    • Time Frame: 3 months
    • This will be assessed using the Oswestry Disability Index (ODI). This is a tool widely used in research and clinical practice to assess disability associated with low back pain. This questionnaire has ten items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulty doing. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.

Secondary Measures

  • Exercise Adherence Rating Scale
    • Time Frame: 3 and 6 months
    • Exercise Adherence Rating Scale (EARS) is a self-report measure that is composed of six items that directly assess adherence behavior (also called as Section B). The six items are scored using an ordinal answer scale (0 = strongly agree to 4 = totally disagree), with higher scores indicating greater adherence (0 to 24).
  • Global Perceived Effect of treatment
    • Time Frame: 3 and 6 months
    • This will be assessed using the Global Perceived Effect Scale (GPES), which is an 11-point scale ranging from -5 (“vastly worse”) through 0 (no change) to +5 (completely recovered).
  • Pain intensity: Brazilian version of the 11-point Numerical Pain Rating Scale (NPRS)
    • Time Frame: 6 months
    • This will be measured using the Brazilian version of the 11-point Numerical Pain Rating Scale (NPRS).The NPRS scale goes from 0 to 10, where 0 is “no pain” and 10 is “the worst pain imaginable”. Participants will be asked to assess their pain levels based on the last seven days.
  • Disability associated with low back pain
    • Time Frame: 6 months
    • This will be assessed using the Oswestry Disability Index (ODI). This is a tool widely used in research and clinical practice to assess disability associated with low back pain. This questionnaire has ten items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulty doing. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
  • Patient Specific Functional Scale (PSFS)
    • Time Frame: 3 and 6 months
    • In the PSFS patients are asked to identify up to three important activities that they are having difficulties with or are unable to perform due to their condition (e.g., low back pain). In addition, the patients are asked to rate, on an 11-point scale (ranging from 0 “unable to perform activity” to 10 “able to perform activity at preinjury level”) their current level of ability associated with each activity.

Participating in This Clinical Trial

Inclusion Criteria

  • Age between 18 to 60 years; – Current episode of CLBP lasting more than 3 months (including cases with pain in the lower limbs); – Seeking primary clinical care for at least 6 weeks ago for this episode of low back pain; – Primary pain located between T12 and the gluteal folds; – Pain intensity equal to or greater than 4 on the 0-10 numerical pain scale; – Pain caused by certain postures, activities and movements; – Score greater than 14% on the Oswestry Disability Index; – And be able to speak and understand Portuguese well to complete the questionnaires. Exclusion Criteria:

  • Classification in red flags (neoplastic diseases or tumors in the spine, inflammatory diseases, infections and fractures); – Leg pain as a primary problem (eg nerve root compression or disc prolapse with active radiculopathy, or lumbar stenosis); – Previous physiotherapy treatments (less than six months before the evaluation period); – History of spine surgery; – Pregnancy; – Rheumatological / inflammatory disease; – Progressive neurological disease.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thais Cristina Chaves, Director – University of Sao Paulo
  • Overall Official(s)
    • Mariana R Lira, Master, Principal Investigator,
    • Ney A Meziat, PhD, Study Director, Augusto Motta University Center (UNISUAM)
    • Thais C Chaves, PhD, Study Director, University of Sao Paulo
  • Overall Contact(s)
    • Thais C Chaves, PhD, +55 (16) 3602-4694, chavestc@fmrp.usp.br

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