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

ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentro Universitário Augusto Motta

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cognitive functional therapy via tele rehabilitation

    Behavioral

    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

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Cognitive functional therapy (CFT) via tele rehabilitationExperimental treatment 1 intervention
Group B: PilatesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disability

Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome

Time frame
12 weeks after randomization

Secondary outcomes

1

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
2

Disability

Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome

Time frame
24 weeks and 48 weeks after randomization
3

Function

Patient Specific Functional Scale (0-10), higher scores mean better outcome

Time frame
12 weeks, 24 weeks and 48 weeks after randomization
4

Anxiety

Brief Psychosocial Questions (0-10), higher scores mean a worse outcome

Time frame
12 weeks, 24 weeks and 48 weeks after randomization

Other outcomes

Sponsors and contacts

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