Low Back Pain
Conditions
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 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.
Interventions
OTHERStandard treatment
The treatment to be used in the study is in accordance with the latest guidelines for chronic LBP \[George et al., 2021; Owen, et al., 2020\]. A warm-up will be performed by walking on a treadmill for 10 minutes, followed by 3 sets of 10 to 15 repetitions of exercise: bridge, cat, abdominal, straight leg raising, and oyster, and 3 sets of 30 to 60 seconds of each isometric exercise (front plank and side plank), where the therapist will assess the optimal amount of repetitions for each individual. The rest period between sets will be 40 seconds, and the rest period between exercises will be 1 minute. The total duration of the session will be 40 minutes \[Sipaviciene et al., 2020; Kim et al, 2020\].
OTHEROsteopathy treatment
The osteopathy treatment group (OTG) will receive the same standard treatment for low back pain as the STG, which will be applied twice a week and osteopathy treatment every 15 days for 8 weeks, totaling 4 sessions. The duration of the osteopathy sessions
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple (Participant, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline and one week and 3 months (follow-up). | Changes in pain intensity, will be assessed using the NPRS (Numerical Pain Rating Scale). This is an 11-point scale where 0 means no pain and 10 means worst possible pain. NPRS outcome measures will be evaluated pre- and post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability caused by low back pain | Baseline and one week | Oswestry Disability Questionnaire (ODQ) will be used to measure disability caused by low back pain. The ODQ is a 10-item scale with higher numbers indicating greater disability. The questionnaire is self-report and includes the following groups of questions: pain intensity and its effect on personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each subscale contains 6 questions and to each question a score from zero to four is assigned. The levels of disability are determined according to the total score as: no disability (0 to 4), mild disability (5 to 14), moderate disability (15 to 24), severe disability (25 to 34), and complete disability (35 to 50). |
| Lumbar mobility | Baseline and one week | Finger-to-floor distance (FFD) will be used to assess lumbar mobility in flexion. |
| Patient-Specific Functional Scale | Baseline and one week | Patients were asked to identify up to three important activities they were having difficulty with or were unable to perform due to their condition (e.g., low back pain). The assessment was conducted using an 11-point scale (ranging from 0 unable to perform activity to 10 able to perform activity at pre-injury level) . |
| Prognostic Risk Assessment | Baseline and one week | The risk of poor prognosis among participants with low back pain, influenced by physical and psychosocial factors, was evaluated using the STarT Back Screening Tool (SBST). The SBST is a 9-item questionnaire that stratifies patients with low back pain into three risk groups (low, medium, and high) that represent their prognosis regarding disability |
Countries
Brazil
Contacts
Primary ContactFabiano Politti, PhD
Backup ContactCaroline Razera, PT
Outcome results
None listed