Clinical trial NCT05480982: Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain
Official title: Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain Treated Via Telerehabilitation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
cognitive functional therapy
telehealth
Pilates
behavioral therapy
exercise therapy
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial with allocation of two parallel groups
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Disability
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Disability
timeFrame: 24 weeks and 48 weeks after randomization
measure: Function
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Anxiety
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Depression
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Catastrophization
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Fear of movement
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Social isolation
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Stress
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Sleep disturbance
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Costs
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
measure: Quality-adjusted life years
timeFrame: 12 weeks, 24 weeks and 48 weeks after randomization
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Centro Universitário Augusto Motta
Study officials:
affiliation: Centro Universitario Augusto Motta - UNISUAM
name: Ney Meziat-Filho, PhD
role: STUDY_DIRECTOR
References:
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