Status:
RECRUITING
Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity
Lead Sponsor:
University of Nove de Julho
Conditions:
Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Background: Low back pain is one of the most common musculoskeletal health problem with the highest prevalence in the adult population; globally, it represents a relevant cause of medical, social and ...
Eligibility Criteria
Inclusion
- Individuals within the age range of 18-70 years;
- Chronic low back pain in the region between the 12th rib and the gluteal fold, with a minimum duration of 6 weeks with or without referral of pain in the lower limbs;
- no specific cause detectable, such as infection, neoplasia, metastasis, osteoporosis, rheumatoid arthritis, fracture, inflammatory process or radicular syndrome.
- baseline pain: minimum intensity score of 3 out of 10 (0 = no pain, 10 = most intense pain) considered and verified by the Numerical Pain Rating Scale (NPRS).
Exclusion
- Previous history of spinal disorders (local trauma, cauda equina syndrome, spinal canal stenosis, congenital abnormalities tumor);
- Inflammatory or infectious diseases (rheumatoid arthritis, fibromyalgia and vertebral osteomyelitis);
- Previous lumbar spine surgery;
- Pregnant women;
- Regular opioid analgesics (≥2 times per week) or opioid patches;
- Receiving disability benefits for back pain or even for another health reason;
- Previous injections for back pain, such as facet joint blocks, nerve root or epidural steroid injection in the previous year;
- Having undergone physical therapy, massage, acupuncture or any other therapeutic intervention for back pain in the previous two weeks;
- Osteopathy techniques that are not used as a treatment for low back pain;
- Neuropathic pain tested with Laségue and Valsalva clinical tests.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06566144
Start Date
September 10 2024
End Date
January 30 2025
Last Update
August 22 2024
Active Locations (1)
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1
Nove de Julho University
São Paulo, Brazil, 06454050