Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity

Recruiting now · Not applicable

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID: NCT06566144
Run by: University of Nove de Julho
People needed: 44
Starts: 2024-09-10
Expected to finish: 2025-01-30
Last updated by the study team: 2024-08-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Nove de Julho University — São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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