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

NCT05480982 | Recruiting

• 1 other identifier: CFT/PILATES/TELE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Low Back Pain

Keywords

low back pain; cognitive functional therapy; telehealth; Pilates; behavioral therapy; exercise therapy

Outcome Measures

Primary Outcomes (1)

• Disability

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

  12 weeks after randomization

Secondary Outcomes (12)

• Pain intensity

  12 weeks, 24 weeks and 48 weeks after randomization

• Disability

  24 weeks and 48 weeks after randomization

• Function

  12 weeks, 24 weeks and 48 weeks after randomization

• Anxiety

  12 weeks, 24 weeks and 48 weeks after randomization

• Depression

  12 weeks, 24 weeks and 48 weeks after randomization

Study Arms (2)

Cognitive functional therapy (CFT) via tele rehabilitation

EXPERIMENTAL

Cognitive 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

Behavioral: Cognitive functional therapy via tele rehabilitation

Pilates

ACTIVE COMPARATOR

Participants 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.

Other: Pilates via tele rehabilitation

Interventions

Cognitive functional therapy via tele rehabilitation BEHAVIORAL

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.

Cognitive functional therapy (CFT) via tele rehabilitation

Pilates via tele rehabilitation OTHER

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.

Pilates

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Centro Universitário Augusto Motta

Rio de Janeiro, Rio de Janeiro, 22793520, Brazil

RECRUITING

Related Publications (11)

• 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.

  PMID: 31630089 BACKGROUND

• 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.

  PMID: 35384931 BACKGROUND

• 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.

  PMID: 29903598 BACKGROUND

• 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.

  PMID: 34971393 BACKGROUND

• 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.

  PMID: 31190411 BACKGROUND

• 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.

  PMID: 35597961 BACKGROUND

• 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.

  PMID: 23208945 BACKGROUND

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

  PMID: 9624662 BACKGROUND

• 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.

  PMID: 24281277 BACKGROUND

• 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.

  PMID: 28919117 BACKGROUND

• 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.

  PMID: 34001421 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ney Meziat-Filho, PhD

  Centro Universitario Augusto Motta - UNISUAM

  STUDY DIRECTOR

Central Study Contacts

Jessica Fernandez, PhD Student

CONTACT

+5521988778037; jessicafmg@gmail.com

Ney Meziat-Filho, PhD

CONTACT

+5521998051386; neymeziat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The assessors were not considered blinded because participants were not blinded and outcomes were self-reported. However, to guarantee that the treatment expectation was evenly balanced between the groups and decrease measurement bias, the participants did not know the study hypothesis, and the assessors did not know the participant's intervention group. The statistician was blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial with allocation of two parallel groups

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: July 29, 2022
• Study Start: September 2, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

BR (1)