About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Cognitive functional therapy via tele rehabilitation
BehavioralParticipants 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.
Pilates via tele rehabilitation
Other interventionPhysiotherapist 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.
Treatment groups
Trial outcomes
Primary outcomes
Disability
Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome
Secondary outcomes
Pain intensity
Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome
Disability
Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome
Function
Patient Specific Functional Scale (0-10), higher scores mean better outcome
Anxiety
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
Sponsors and contacts
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