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Low Back PainNCT05480982

Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain

A study testing Cognitive functional therapy via tele rehabilitation and Pilates via tele rehabilitation in people with Low Back Pain, run by Centro Universitário Augusto Motta at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

There is evidence of three randomized controlled trials that face-to-face CFT reduces disability compared with active interventions for adults with chronic low back pain. The pandemic enabled the popularization of tele rehabilitation around the globe, but there are still no clinical trial testing the effectiveness of… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Low Back Pain
What is being tested?
Cognitive functional therapy via tele rehabilitation and Pilates via tele rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteBrazil
Study dates
2 Sep 2022to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • A main complaint of pain in the area between the 12th rib and buttock crease with or without accompanying non-radicular leg pain;
  • Episode of ongoing low back pain for at least 12 weeks' duration;
  • Presenting to a primary care clinician at least 6 weeks ago for this episode of LBP;
  • Being able to walk independently (with or without aids);
  • Ability to understand Portuguese well enough to be able to fill in the questionnaires.
  • Medium or high risk score on STartback screening tool.

Who cannot join

  • Known or suspected red flag disorders like fracture, malignancy/cancer, cauda equina syndrome or progressive neurological disorder, inflammatory or infective diseases of the spine;
  • Suspected radicular pain (dominant leg pain, positive neural tissue provocation tests and/or any two of altered strength, reflexes or sensation for the same nerve root, assessed clinically);
  • Spinal surgery < 6 months previously;
  • Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last three months;
  • Scoliosis (if considered the primary cause of pain);
  • Unstable heart conditions;
Show all 9Show fewer
  • Chikungunya or Dengue virus disease transmitted by mosquitoes;
  • Relevant cognition deficit measured by 10 point cognitive screener, with a cut-off point of less than 8 points, 18 for participants with elementary education, and 26 for participants with secondary and/or higher education;
  • Post Covid-19 sequelae of pain.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Fernandez, PhD Student contact

+5521988778037

jessicafmg@gmail.com

Ney Meziat-Filho, PhD contact

+5521998051386

neymeziat@gmail.com

Brazil1 site, 1 recruiting

  • Centro Universitário Augusto Motta

    Rio de Janeiro, Rio de Janeiro, 22793520

    Ney Meziat-Filho, PhD, +55 21 998051386, neymeziat@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain Treated Via Telerehabilitation: A Randomized Controlled Trial

There is evidence of three randomized controlled trials that face-to-face CFT reduces disability compared with active interventions for adults with chronic low back pain. The pandemic enabled the popularization of tele rehabilitation around the globe, but there are still no clinical trial testing the effectiveness of Cognitive Functional Therapy (CFT) via tele rehabilitation for elderly people with chronic low back pain. The aim of this study is to investigate the effectiveness of CFT compared with Pilates, both via tele rehabilitation in elderly patients with chronic low back pain.

Read the detailed description

This will be a parallel-group randomized controlled trial with intention to treat analysis conducted via tele rehabilitation in Brazil. Two hundreds elderly people with chronic low back pain (except low risk on STartback screening tool) will be randomized to receive CFT (2 individualized sessions and 4-8 group sessions) or group Pilates (6-10 sessions) up to 12 weeks treatment. Participants will be assessed at baseline, post-intervention (12 weeks) 24 and 48 weeks after randomization. The trial will include cost-effectiveness and cost-utility analyses. Data of quality of life, healthcare costs, patient and family costs, and absenteism costs will be collected. The cost-effectiveness analysis will be performed using disability and pain intensity as outcomes. Costs and quality-adjusted life years will be used to calculate cost-utility.

Three qualitative studies will be conducted during the trial. The first will be performed by means of the interviews with a subsample of the participants before randomization. The aim will be to investigate how elderly people with chronic low back pain perceive their condition. The second will be performed by means of the analysis of a subsample of video recordings of CFT treatments. The aim will be to investigate the narratives of elderly people with chronic low back pain during CFT treatment sessions. The third will be performed after the last follow up by means of an interview with a subsample of participants that received CFT treatment. The aim will be to investigate the perceptions of elderly people with chronic low back pain about the impact of CFT via telerehabilitation.

Conditions
Low Back Pain
Being tested
Cognitive functional therapy via tele rehabilitation, Pilates via tele rehabilitation
Keywords
low back pain, cognitive functional therapy, telehealth, Pilates, behavioral therapy, exercise therapy
Medical subject headings
Low Back Pain

What participants receive

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

  • Cognitive functional therapy via tele rehabilitationBehavioural

    Participants in the CFT group will be treated by a physiotherapist with seventeen years of clinical experience and that has attended six CFT workshops with three of the international tutors of the method. She has completed 212 hours of training including workshops, patient examinations and a pilot study under the supervision of a physiotherapist with more than seven years of clinical experience in CFT. Another two physiotherapists, one with more than fifteen years and the other with more than ten years of clinical experience, and both with more than 106 hours of CFT training including CFT via tele physiotherapy, will complete the staff.

  • Pilates via tele rehabilitationOther

    Physiotherapist will have the freedom to judge about the exercises´ progression and the need of adaptation considering both the level of difficulty to perform each exercise according to the original proposal and the individual´s demands. The treating physiotherapists will have at least 2 years of clinical practice in Pilates and clinical experience in Pilates via teleconference.

Study groups in NCT05480982
Study groupRoleWhat they receive
Cognitive functional therapy (CFT) via tele rehabilitationExperimentalCognitive Functional Therapy (CFT) is a physiotherapy-led intervention which has evolved from an integration of foundational behavioral psychology and neuroscience within the physiotherapy practice directed at the multidimensional biopsychosocial nature of low back pain. The clinical journey is adapted to the individual's profile following three main components: (i) making sense of pain, (ii) exposure with control and (iii) lifestyle changes. The first 2 one-hour treatment sessions of CFT will be delivered individually and via videoconference in a weekly basis. The following one-hour treatment sessions (from 6 to 9 sessions) will be delivered in groups (up to 6 participants). One group booster session will be delivered 20 weeks after randomization
Receives: Behavioral: Cognitive functional therapy via tele rehabilitation
PilatesActive comparatorParticipants in the comparison group will receive Pilates method using classic principles and exercises recommended by Joseph Pilates. No specific accessories or equipment will be used, allowing the exercises to be performed under any circumstances. Based on Pilates, 10 exercises were selected: Leg Pull Front, One Leg Circle, One Leg Kick, One leg stretch, Shoulder bridge, Side bend, Spine Stretch , Swimming, The hundred and The Saw. The main objective of the exercises is to improve physical capacities, including mobility, flexibility, muscle strength and activation of the "power house" center of force, with the therapeutic aim of a positive evolution of chronic non-specific low back pain. The one-hour sessions will be delivered once a week. Participants will be instructed to perform the set of exercises once a week without the supervision of the physiotherapist. The number of group sessions (up to 6 participants) will vary between 8 to 12.
Receives: Other: Pilates via tele rehabilitation

What is being measured

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

  1. Disability

    Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome

    Measured: 12 weeks after randomization

Secondary outcomes (12)

  1. Pain intensity

    Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  2. Disability

    Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome

    Measured: 24 weeks and 48 weeks after randomization

  3. Function

    Patient Specific Functional Scale (0-10), higher scores mean better outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  4. Anxiety

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  5. Depression

    Brief Psychosocial Questions (0-10),higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  6. Catastrophization

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  7. Fear of movement

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  8. Social isolation

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  9. Stress

    Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  10. Sleep disturbance

    Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  11. Costs

    Assessments of healthcare costs, patients and family costs, and absenteeism costs by a specific questionnaire (total costs in £)

    Measured: 12 weeks, 24 weeks and 48 weeks after randomization

  12. Quality-adjusted life years

    SF-6D questionnaire (0-1), higher scores mean a better outcome

    Measured: 12 weeks, 24 weeks and 48 weeks 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 posted29 Jul 2022
  2. Study start2 Sep 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2028 (estimated)

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 clinical trial with allocation of two parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05480982
Sponsor's protocol ID
CFT/PILATES/TELE
Status last verified
May 2026
First submitted
27 May 2022
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.

    PubMed 31630089

  • Castro J, Correia L, Donato BS, Arruda B, Agulhari F, Pellegrini MJ, Belache FTC, de Souza CP, Fernandez J, Nogueira LAC, Reis FJJ, Ferreira AS, Meziat-Filho N. Cognitive functional therapy compared with core exercise and manual therapy in patients with chronic low back pain: randomised controlled trial. Pain. 2022 Dec 1;163(12):2430-2437. doi: 10.1097/j.pain.0000000000002644. Epub 2022 Apr 4.

    PubMed 35384931

  • Belache FTC, Souza CP, Fernandez J, Castro J, Ferreira PDS, Rosa ERS, Araujo NCG, Reis FJJ, Almeida RS, Nogueira LAC, Correia LCL, Meziat-Filho N. Trial Protocol: Cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain: protocol for a randomised, controlled trial. J Physiother. 2018 Jul;64(3):192. doi: 10.1016/j.jphys.2018.02.018. Epub 2018 Jun 11.

    PubMed 29903598

  • Caneiro JP, Smith A, Bunzli S, Linton S, Moseley GL, O'Sullivan P. From Fear to Safety: A Roadmap to Recovery From Musculoskeletal Pain. Phys Ther. 2022 Feb 1;102(2):pzab271. doi: 10.1093/ptj/pzab271.

    PubMed 34971393

  • Fernandez J, Ferreira AS, Castro J, Correia LCL, Meziat-Filho N. Comment on the paper "Cognitive functional therapy in patients with non specific chronic low back pain", by Vibe Fersum et al. Eur J Pain. 2019 Sep;23(8):1574-1575. doi: 10.1002/ejp.1441. Epub 2019 Jun 26. No abstract available.

    PubMed 31190411

  • Miki T, Kondo Y, Kurakata H, Buzasi E, Takebayashi T, Takasaki H. The effect of cognitive functional therapy for chronic nonspecific low back pain: a systematic review and meta-analysis. Biopsychosoc Med. 2022 May 21;16(1):12. doi: 10.1186/s13030-022-00241-6.

    PubMed 35597961

  • 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

  • American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.

    PubMed 9624662

  • 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

  • GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.

    PubMed 28919117

  • Fernandez J, Lunkes LC, Meziat-Filho N. Biopsychosocial approaches to telerehabilitation for chronic primary musculoskeletal pain: A real possibility for physical therapists, that is here to stay. Braz J Phys Ther. 2022 Jan-Feb;26(1):100350. doi: 10.1016/j.bjpt.2021.04.011. Epub 2021 May 9. No abstract available.

    PubMed 34001421

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive functional therapy via tele rehabilitation and Pilates via tele rehabilitation in people with Low 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Jessica Fernandez, PhD Student (+5521988778037, jessicafmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability (time frame: 12 weeks after randomization). 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 NCT05480982, which also lists 11 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 7 May 2026.

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