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

NCT06566144 | Recruiting

• 1 other identifier: FP004
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disability caused by low back pain

  Baseline and one week

• Lumbar mobility

  Baseline and one week

• Patient-Specific Functional Scale

  Baseline and one week

• Prognostic Risk Assessment

  Baseline and one week

Study Arms (2)

Osteopathy treatment

EXPERIMENTAL

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

Other: Osteopathy treatment

Standard treatment

ACTIVE COMPARATOR

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

Other: Standard treatment

Interventions

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

Standard treatment

Osteopathy treatment 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

Osteopathy treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 06454050, Brazil

RECRUITING

Related Publications (4)

• George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.

  PMID: 34719942 BACKGROUND

• Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.

  PMID: 32669487 BACKGROUND

• Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.

  PMID: 31666220 BACKGROUND

• Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.

  PMID: 31923778 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fabiano Politti, PhD

CONTACT

55 11 989418885; fabianopolitti@gmail.com

Caroline Razera, PT

CONTACT

55 19 982110053; carolinerazeraf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Fabiano Politti, FT

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 22, 2024
• Study Start: September 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 30, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)