Actively Recruiting
Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity
Led by University of Nove de Julho · Updated on 2024-08-22
44
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 economic burden. The aim of the proposed study is to determine the effect of a standard treatment for non-specific low back (CNSLBP) combined with multimodal osteopathy treatment on pain intensity and functional capacity. Methods: This will be a blind randomized clinical trial, with 44 patients with CNSLBP, randomly assigned into two groups: Experimental group (EG) treated with therapeutic exercises and multimodal osteopathy treatment (n=22) and Control group (CG) treated with therapeutic exercises (n=22). Participants will receive treatment twice a week (total of 16 sessions). The primary outcome is pain, measured by numeric rating scale (NRS: score 0-11 points). Secondary outcomes are: Patient-specific functional scale (scored from 0 to 30), Oswestry Disability Questionnaire (ODQ), finger-to-floor distance test (FFD). Participants will be evaluated pre- and post-treatment and after 1 and 3 months (follow-up). Results: Analysis will be by intention to treat using linear mixed models. Comparisons between groups before and after treatment will demonstrate whether osteopathy treatment exerts a supplementary effect on pain and functional capacity in patients with CNSLBP. The data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with CNSLBP.
CONDITIONS
Official Title
Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged between 18 and 70 years
- Chronic low back pain lasting at least 6 weeks in the area between the 12th rib and gluteal fold
- Pain may or may not radiate to the lower limbs
- No specific causes such as infection, cancer, osteoporosis, rheumatoid arthritis, fracture, or radicular syndrome
- Baseline pain intensity of at least 3 out of 10 on the Numeric Pain Rating Scale
You will not qualify if you...
- Previous spinal disorders such as local trauma, cauda equina syndrome, spinal canal stenosis, congenital abnormalities, or tumor
- Inflammatory or infectious diseases like rheumatoid arthritis, fibromyalgia, or vertebral osteomyelitis
- Previous lumbar spine surgery
- Pregnant women
- Regular use of opioid pain medication (2 or more times per week) or opioid patches
- Receiving disability benefits for back pain or other health reasons
- Previous back pain injections in the past year
- Physical therapy, massage, acupuncture, or other back pain treatments in the last two weeks
- Use of osteopathy techniques not meant for low back pain
- Presence of neuropathic pain as tested by Las�e9gue and Valsalva clinical tests
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nove de Julho University
São Paulo, Brazil, 06454050
Actively Recruiting
Research Team
F
Fabiano Politti, PhD
CONTACT
C
Caroline Razera, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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