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Completed

NCT Number: NCT03221439

Cognitive Functional Therapy for Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitário Augusto Motta

Rio de Janeiro, 21.041-020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Functional Therapy

Behavioral

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

Manual Therapy and Motor Control Exercise

Other

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.

Primary outcomes

  1. Pain intensity

    Time frame: 3 months after randomization

    It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days

  2. Disability associated to low back pain

    Time frame: 3 months after randomization

    It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.

Secondary outcomes

  1. Global impression of recovery

    Time frame: 3, 6 and 12 months after randomization

    It will be evaluated based on 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).

  2. Pain intensity

    Time frame: 6 and 12 months after randomization

    It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END) 13. The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days.

  3. Disability associated to low back pain

    Time frame: 6 and 12 months after randomization

    It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.

  4. Patient Satisfaction

    Time frame: 3, 6 and 12 months after randomization

    This is a simple questionnaire from 1 to 5 asking the patients how satisfied they were with their treatment: 1 = satisfied, 2 = just a little satisfied, 3 = neither satisfied nor dissatisfied, 4 = just a little dissatisfied, 5 = dissatisfied

Other outcomes

  1. Anxiety (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be evaluated by the question "Do you feel anxious?"with the response options ranging from "Not at all" = 0 to "Quite anxious" = 10

  2. Social isolation (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be evaluated by the question"Do you feel socially isolated?"with the response options ranging from "Not at all isolated" = 0 to "Quite isolated" = 10

  3. Catastrophization (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be evaluated by the question "When I feel pain, it's terrible and I feel it's never going to get any better."with the response options ranging from "Never do that" = 0 to "Always do that" = 10.

  4. Depression (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be evaluated by the question "During the past month have you often been bothered by feeling down, depressed or hopeless?" with the response options ranging from "Never" = 0 to "All the time" = 10.

  5. Fear of movement (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be assessed by the question "Physical activity might harm my back" and the response options will range from 0 ("completely disagree") to 10 ("completely agree).

  6. Stress (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be evaluated by the question "Do you feel stressed? and the response options will range from 0 ("completely disagree") to 10 ("completely agree)

  7. Sleep (mediator of outcome)

    Time frame: 3 and 6 months after randomization

    It will be evaluated by the question "Did you have sleep problems last month?" based on Subjective Health Complaints Inventory19. The response options will be "Not at all"=0, "A little"=1, "Some"=2, and "Serious"=3

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2017
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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