Comparing Cognitive Functional Therapy and Pilates for Chronic Low Back Pain in the Elderly

Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain Treated Via Telerehabilitation: A Randomized Controlled Trial

This study is testing whether Cognitive Functional Therapy delivered online is better than Pilates for helping older adults with chronic low back pain feel less pain and improve their daily life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Centro Universitário Augusto Motta (Academic / other)
• Locations: 1 site (Rio de Janeiro, Rio de Janeiro)
• Trial ID: NCT05480982 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Cognitive Functional Therapy (CFT) delivered via tele rehabilitation compared to Pilates for elderly patients suffering from chronic low back pain. A total of 200 participants will be randomized to receive either CFT or Pilates over a treatment period of up to 12 weeks. Assessments will be conducted at baseline, post-intervention, and at 24 and 48 weeks to evaluate outcomes such as pain intensity, disability, and quality of life. The study also includes qualitative research to understand participants' perceptions and experiences during treatment.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals with chronic low back pain who can walk independently and understand Portuguese.

Not a fit: Patients with serious underlying conditions such as fractures, malignancies, or recent spinal surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective tele rehabilitation option for elderly patients with chronic low back pain, improving their quality of life.

How similar studies have performed: Previous studies have shown that Cognitive Functional Therapy can reduce disability in adults with chronic low back pain, but this specific tele rehabilitation approach for the elderly is novel.

Eligibility criteria

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.

Where this trial is running

Rio de Janeiro, Rio de Janeiro

• Centro Universitário Augusto Motta — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)

Study contacts

• Study coordinator: Jessica Fernandez, PhD Student

Conditions Low Back Pain; low back pain; cognitive functional therapy; telehealth; Pilates; behavioral therapy; exercise therapy