Combining standard treatment with osteopathy for low back pain relief

Effect of a Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity: A Randomized, Controlled, Blinded Trial"

This study is testing if adding osteopathy to standard treatment for chronic low back pain can help people feel better and move more easily.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Nove de Julho (other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT06566144 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a standard treatment for chronic non-specific low back pain combined with multimodal osteopathy treatment. It will involve 44 participants who will be randomly assigned to either an experimental group receiving both therapeutic exercises and osteopathy or a control group receiving only therapeutic exercises. The treatments will be administered twice a week over a total of 16 sessions, with pain intensity and functional capacity as primary and secondary outcomes measured through various scales. The study seeks to provide insights into the potential benefits of integrating osteopathy into standard care for low back pain.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with chronic low back pain lasting at least 6 weeks and no identifiable specific cause.

Not a fit: Patients with specific spinal disorders, inflammatory diseases, or those who have undergone previous lumbar spine surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and improve functional capacity for patients suffering from chronic low back pain.

How similar studies have performed: While there is ongoing research in the field, the combination of standard treatment with multimodal osteopathy for low back pain is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

São Paulo

• Nove de Julho University — São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Fabiano Politti, PhD

Conditions: Low Back Pain