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

May 3, 2026 updated by: Centro Universitário Augusto Motta

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22793520
        • Recruiting
        • Centro Universitário Augusto Motta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive functional therapy (CFT) via tele rehabilitation

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 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.
Active Comparator: Pilates
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 12 weeks after randomization
Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome
12 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Disability
Time Frame: 24 weeks and 48 weeks after randomization
Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome
24 weeks and 48 weeks after randomization
Function
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Patient Specific Functional Scale (0-10), higher scores mean better outcome
12 weeks, 24 weeks and 48 weeks after randomization
Anxiety
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Depression
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Brief Psychosocial Questions (0-10),higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Catastrophization
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Fear of movement
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Social isolation
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Stress
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Sleep disturbance
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome
12 weeks, 24 weeks and 48 weeks after randomization
Costs
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
Assessments of healthcare costs, patients and family costs, and absenteeism costs by a specific questionnaire (total costs in £)
12 weeks, 24 weeks and 48 weeks after randomization
Quality-adjusted life years
Time Frame: 12 weeks, 24 weeks and 48 weeks after randomization
SF-6D questionnaire (0-1), higher scores mean a better outcome
12 weeks, 24 weeks and 48 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitário Augusto Motta

Investigators

  • Study Director: Ney Meziat-Filho, PhD, Centro Universitario Augusto Motta - UNISUAM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFT/PILATES/TELE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Cognitive functional therapy via tele rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe