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The effects of Osteopathic Treatment with specific techniques in patients with chronic non-specific back pain

The effects of specific Osteopathic Manipulative Treatment in patients with non-specific Chronic Low Back Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5tw3rrr
Enrollment
Unknown
Registered
2022-12-27
Start date
2023-02-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Interventions

The present study is a double-blind randomized controlled clinical trial with two intervention arms, a control group (CG) and an experimental group (EG). About blinding, it will be a double blind wher
E02.190.599.280

Sponsors

Silvia de Lima Filó Lins
Lead Sponsor
Clinica Reabilitar
Collaborator
Universidade Federal do Rio de Janeiro - UFRJ - Campus Macaé
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Both sexes. Adults from 18 to 65 years old. Chronic non-specific low back pain for more than 3 months. With or without irradiation to the lower limb. Numerical rating scale of the same or greater than 2 in the last week. Score not greater than Roland Morris disability equal to 4.

Exclusion criteria

Exclusion criteria: Spinal canal stenosis, spine surgery or hip arthroplasty, recent trauma or fracture; infection, active cancer; reporting unexplained weight loss in the last month; pregnancy, breastfeeding or expecting to become pregnant in the next 3 months; neurological disorders such as cauda equina syndrome, spinal cord injury, alzheimer's, amyotrophic lateral sclerosis, multiple sclerosis, parkinson's, stroke; cardiorespiratory disorders, congestive heart failure, heart attack within the last 24 months, or any bleeding disorder; musculoskeletal disorders such as advanced osteoporosis, rheumatoid arthritis, avascular necrosis or osteonecrosis, osteoarthritis, use of narcotics or muscle relaxants during study enrollment, report having received any manual therapy intervention applied to the spine 30 days prior to the first study intervention, have a body mass index > 35 kg/m2

Design outcomes

Primary

MeasureTime frame
To verify the influence of specific osteopathic manipulative treatment for patients with non-specific chronic low back pain. It will be verified by means of the visual analogue pain scale and by digital algometry using a MED.DOR® pressure algometer, to find an average difference of 20% in the variable between the groups with an alpha of 0.05 and a power of 80 %.

Secondary

MeasureTime frame
To verify the influence of specific osteopathic manipulative treatment on the functional disability of patients with chronic nonspecific low back pain. It will be verified through the Roland Morris questionnaire, to find an average difference of 20% in the variable between the groups with an alpha of 0.05 and a power of 80%;To quantify lower limb muscle strength in patients with chronic nonspecific low back pain undergoing specific osteopathic manipulative treatment. It will be verified by digital manual dynamometry using the DYNAMOP® dynamometer, to find an average difference of 20% in the variable between groups with an alpha of 0.05 and a power of 80%. ;To quantify vertebral and posterior chain range of motion in patients with chronic nonspecific low back pain undergoing specific osteopathic manipulative treatment. It will be verified by measuring the distance finger on the ground using a tape measure to measure the movement of trunk flexion; and measured by a Sanny® brand gravitational pendulum fleximeter to assess trunk flexion, extension and inclination movements, to find an average difference of 20% in the variable between the groups with an alpha of 0.05 and a power of 80%. ;To assess the psychosocial risk of patients with chronic nonspecific low back pain undergoing specific osteopathic manipulative treatment using the Start Back questionnaire, to find an average difference of 20% in the variable between the groups with an alpha of 0.05 and a power of 80%.;To evaluate the global effect perceived in patients with chronic non-specific low back pain undergoing specific osteopathic manipulative treatment using the Global Perceived Effect Scale, to find an average difference of 20% in the variable between the groups with an alpha of 0.05 and a power of 80%.

Countries

Brazil

Contacts

Public ContactSilvia Lins

Universidade Federal do Rio de Janeiro - UFRJ - Campus Macaé

silviadelimalins@hotmail.com+55-22-988347996

Outcome results

None listed

Source: REBEC (via WHO ICTRP)