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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome | 12 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Disability | Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Fernandez, PhD Student | Contact | +5521988778037 | jessicafmg@gmail.com | |
| Ney Meziat-Filho, PhD | Contact | +5521998051386 | neymeziat@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ney Meziat-Filho, PhD | Centro Universitario Augusto Motta - UNISUAM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitário Augusto Motta | Recruiting | Rio de Janeiro | Rio de Janeiro | 22793520 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31630089 | Background | 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. | |
| 35384931 |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Randomized controlled clinical trial with allocation of two parallel groups
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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.
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| 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. |
|
| 24 weeks and 48 weeks after randomization |
| Function | Patient Specific Functional Scale (0-10), higher scores mean better outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Anxiety | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Depression | Brief Psychosocial Questions (0-10),higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Catastrophization | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Fear of movement | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Social isolation | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Stress | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Sleep disturbance | Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| Costs | Assessments of healthcare costs, patients and family costs, and absenteeism costs by a specific questionnaire (total costs in £) | 12 weeks, 24 weeks and 48 weeks after randomization |
| Quality-adjusted life years | SF-6D questionnaire (0-1), higher scores mean a better outcome | 12 weeks, 24 weeks and 48 weeks after randomization |
| 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. |
| 29903598 | 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. |
| 34971393 | 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. |
| 31190411 | 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. |
| 35597961 | 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. |
| 23208945 | 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. |
| 9624662 | 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. |
| 24281277 | 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. |
| 28919117 | 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. |
| 34001421 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |