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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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05480982
Study type Interventional
Source Centro Universitário Augusto Motta
Contact Jessica Fernandez, PhD Student
Phone +5521988778037
Email jessicafmg@gmail.com
Status Recruiting
Phase N/A
Start date September 2, 2022
Completion date September 2025
View Details
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