Low Back Pain
Conditions
Keywords
low back pain, cognitive functional therapy, telehealth, Pilates, behavioral therapy, exercise therapy
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.
Interventions
BEHAVIORALCognitive 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.
OTHERPilates 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.
Sponsors
Centro Universitário Augusto Motta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The assessors were not considered blinded because participants were not blinded and outcomes were self-reported. However, to guarantee that the treatment expectation was evenly balanced between the groups and decrease measurement bias, the participants did not know the study hypothesis, and the assessors did not know the participant's intervention group. The statistician was blinded to the group allocation.
Intervention model description
Randomized controlled clinical trial with allocation of two parallel groups
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 12 weeks after randomization | Quebec Back Pain Disability Scale (0-100), higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 12 weeks, 24 weeks and 48 weeks after randomization | Numerical Pain Rating Scale (0-10), higher scores mean a worse outcome |
| Disability | 24 weeks and 48 weeks after randomization | Quebec Back Pain Disability Scale (0-100), higher scores mean a worse outcome |
| Function | 12 weeks, 24 weeks and 48 weeks after randomization | Patient Specific Functional Scale (0-10), higher scores mean better outcome |
| Anxiety | 12 weeks, 24 weeks and 48 weeks after randomization | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome |
| Depression | 12 weeks, 24 weeks and 48 weeks after randomization | Brief Psychosocial Questions (0-10),higher scores mean a worse outcome |
| Catastrophization | 12 weeks, 24 weeks and 48 weeks after randomization | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome |
| Fear of movement | 12 weeks, 24 weeks and 48 weeks after randomization | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome |
| Social isolation | 12 weeks, 24 weeks and 48 weeks after randomization | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome |
| Stress | 12 weeks, 24 weeks and 48 weeks after randomization | Brief Psychosocial Questions (0-10), higher scores mean a worse outcome |
| Sleep disturbance | 12 weeks, 24 weeks and 48 weeks after randomization | Subjective Health Complaints Inventory (0-3), higher scores mean a worse outcome |
| Costs | 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 £) |
| Quality-adjusted life years | 12 weeks, 24 weeks and 48 weeks after randomization | SF-6D questionnaire (0-1), higher scores mean a better outcome |
Countries
Brazil
Contacts
CONTACTJessica Fernandez, PhD Student
CONTACTNey Meziat-Filho, PhD
STUDY_DIRECTORNey Meziat-Filho, PhD
Centro Universitario Augusto Motta - UNISUAM
Outcome results
None listed