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

NCT05480982 · tracked via the Priya Life Science Brazil tracker

Sponsor

Centro Universitário Augusto Motta

Phase

Not applicable

Started

2022-09-02

Last updated

2026-05-07

Condition(s) studied

Low Back Pain

Investigational drug(s) / intervention(s)

Cognitive functional therapy via tele rehabilitationPilates via tele rehabilitation

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Disability — 12 weeks after randomization
Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome

Trial sites (1)

Facility	City	Region	Status
Centro Universitário Augusto Motta	Rio de Janeiro	Rio de Janeiro	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05480982 on ClinicalTrials.gov ↗ ← All trials in Brazil