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Low Back PainNCT03221439

Cognitive Functional Therapy for Chronic Low Back Pain

A study testing Cognitive Functional Therapy in people with Low Back Pain and Back Pain, run by Centro Universitário Augusto Motta at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain, Back Pain, Pain
What is being tested?
Cognitive Functional Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteBrazil
Study dates
1 Aug 2017to 12 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro Universitário Augusto Motta

    Rio de Janeiro, 21.041-020

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Cognitive Functional Therapy, Manual Therapy and Motor Control Exercise
Keywords
back pain, physiotherapy, exercise therapy, cognitive functional therapy, low back pain, backache, lower back pain, lumbago, multidimensional, biopsychosocial
Medical subject headings
Low Back Pain, Back Pain, Pain, Signs and Symptoms, Neuromuscular Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Functional TherapyBehavioural

    There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):

    1. 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.
    2. Specific Functional training is designed to normalize maladaptive or provocative movement and posture.
    3. 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)
    4. 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 ExerciseOther

    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.

Study groups in NCT03221439
Study groupRoleWhat they receive
Cognitive Functional TherapyExperimentalCognitive Functional Therapy (CFT) is a behavioral intervention that addresses multiple aspects of low back pain. This approach focuses on changing the patient's beliefs, confronting their fears, educating them about pain mechanisms, increasing mental strength, and control of their body. This is done with functional tasks performed by individuals training them to reduce excessive muscle activity in the trunk and generate behavioral changes related to pain, from postures and provocative movements.
Receives: Behavioral: Cognitive Functional Therapy
Manual Therapy and ExerciseActive comparatorThe active comparator will be the combination of manual therapy and motor control exercises.
Receives: Other: Manual Therapy and Motor Control Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    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

    Measured: 3 months after randomization

  2. Disability associated to low back pain

    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 %.

    Measured: 3 months after randomization

Secondary outcomes (4)

  1. Global impression of recovery

    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).

    Measured: 3, 6 and 12 months after randomization

  2. Pain intensity

    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.

    Measured: 6 and 12 months after randomization

  3. Disability associated to low back pain

    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 %.

    Measured: 6 and 12 months after randomization

  4. Patient Satisfaction

    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

    Measured: 3, 6 and 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start1 Aug 2017
  3. Primary completion12 Jan 2020
  4. Study completion12 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03221439
Sponsor's protocol ID
CFT/MTEX
Status last verified
Sep 2020
First submitted
16 Jul 2017
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27745712

  • 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.

    PubMed 21821612

  • 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.

    PubMed 27002443

  • 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.

    PubMed 24480940

  • 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.

    PubMed 23091394

  • 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.

    PubMed 26742533

  • 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.

    PubMed 26033941

  • 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.

    PubMed 23208945

  • 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.

    PubMed 25920336

  • 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.

    PubMed 27052627

  • 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.

    PubMed 24281277

  • 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.

    PubMed 24665116

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Functional Therapy in people with Low Back Pain and Back Pain, run by Centro Universitário Augusto Motta at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: 3 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03221439, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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