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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
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.
Centro Universitário Augusto Motta
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGDisability
Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome
Time frame: 12 weeks after randomization
Pain intensity
Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Disability
Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome
Time frame: 24 weeks and 48 weeks after randomization
Function
Patient Specific Functional Scale (0-10), higher scores mean better outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Anxiety
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Depression
Brief Psychosocial Questions (0-10),higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Catastrophization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Fear of movement
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Social isolation
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Stress
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Sleep disturbance
Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome
Time frame: 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 £)
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
Quality-adjusted life years
SF-6D questionnaire (0-1), higher scores mean a better outcome
Time frame: 12 weeks, 24 weeks and 48 weeks after randomization
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