An interventional study of Cognitive functional therapy via tele rehabilitation and Pilates via tele rehabilitation in Low Back Pain, sponsored by Centro Universitário Augusto Motta. Recruiting at 1 site in Brazil. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Centro Universitário Augusto Motta · Not applicable, Interventional, and Treatment
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Centro Universitário Augusto Motta is the lead sponsor of 39 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Cognitive functional therapy via tele rehabilitation
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.
Other: Pilates 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.
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.
Disability
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
Started Sep 2022 (actual). Primary completion is estimated for Jul 2027, 58 months after the start.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 58 months is above that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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Centro Universitário Augusto Motta