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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple (Participant, Investigator, Outcomes Assessor)

Study Groups

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Osteopathy treatment

The osteopathy treatment group (OTG) will be submitted to a clinical method considered the gold standard for the treatment of non-specific low back pain together with osteopathy treatment

Group Type EXPERIMENTAL

Osteopathy treatment

Intervention Type OTHER

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

Standard treatment

The Standard treatment group (STG) will only receive the gold standard method for the treatment of low back pain.

Group Type ACTIVE_COMPARATOR

Standard treatment

Intervention Type OTHER

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 \[Sipaviciene et al., 2020; Kim et al, 2020\].

Interventions

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Standard 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 \[Sipaviciene et al., 2020; Kim et al, 2020\].

Intervention Type OTHER

Osteopathy 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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No