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Compares treatment options for Low Back Pain
Official title Cognitive Functional Therapy Compared With Pilates in Elderly Patients With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT05480982
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
You likely can't join if
- Known or suspected red flag disorders like fracture, malignancy/cancer, cauda equina syndrome or progressive neurological disorder, inflammatory or...
- Suspected radicular pain (dominant leg pain, positive neural tissue provocation tests and/or any two of altered strength, reflexes or sensation for...
- 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;
See the full eligibility 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.
- 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...
- Post Covid-19 sequelae of pain.
The study team makes the final eligibility decision.
Where it's taking place
- Rio de Janeiro, Rio de Janeiro, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rio de Janeiro, Rio de Janeiro, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.