Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity
NCT Number: NCT06566144
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: OTHER: Standard treatment|OTHER: Osteopathy treatment
Sponsor: University of Nove de Julho
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2025-01-30
Locations: Nove de Julho University, São Paulo, 06454050, Brazil

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.

Primary Outcome Measures: Pain intensity, 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., Baseline and one week and 3 months (follow-up).
Secondary Outcome Measures: Disability caused by low back pain, 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)., Baseline and one week|Lumbar mobility, Finger-to-floor distance (FFD) will be used to assess lumbar mobility in flexion., Baseline and one week|Patient-Specific Functional Scale, 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") ., Baseline and one week|Prognostic Risk Assessment, 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, Baseline and one week