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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480982
• Other study ID #: CFT/PILATES/TELE
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Centro Universitário Augusto Motta
• Contact: Jessica Fernandez, PhD Student
• Phone: +5521988778037
• Email: jessicafmg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 ten years of clinical experience, and both with more than 106 hours of CFT training including CFT via tele physiotherapy, will complete the staff.

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.

Locations

Country	Name	City	State
Brazil	Centro Universitário Augusto Motta	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2017 Oct 28;390(10106):e38. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome	12 weeks after randomization
Secondary	Pain intensity	Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Disability	Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome	24 weeks and 48 weeks after randomization
Secondary	Function	Patient Specific Functional Scale (0-10), higher scores mean better outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Anxiety	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Depression	Brief Psychosocial Questions (0-10),higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Catastrophization	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Fear of movement	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Social isolation	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Stress	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	Sleep disturbance	Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome	12 weeks, 24 weeks and 48 weeks after randomization
Secondary	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
Secondary	Quality-adjusted life years	SF-6D questionnaire (0-1), higher scores mean a better outcome	12 weeks, 24 weeks and 48 weeks after randomization