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

Official title

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

Overview

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.

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.

Interventions

• Behavioral Cognitive functional therapy via tele rehabilitation
  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 te
• Other Pilates via tele rehabilitation
  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.

Primary outcome measures

• Disability [Time frame: 12 weeks after randomization]

Secondary outcome measures (12)

• Pain intensity [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Disability [Time frame: 24 weeks and 48 weeks after randomization]
• Function [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Anxiety [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Depression [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Catastrophization [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Fear of movement [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Social isolation [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Stress [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Sleep disturbance [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Costs [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]
• Quality-adjusted life years [Time frame: 12 weeks, 24 weeks and 48 weeks after randomization]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Centro Universitário Augusto Motta — Rio de Janeiro

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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 9624662

Identifiers

NCT: NCT05480982 · CFT/PILATES/TELE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗