Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain

The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.

The main questions it aims to answer were:

* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica? * Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?

Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group.

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Key information

Conditions

Low Back Pain Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Disc Herniation Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms Spinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 55 years old.
Chronic (at least six months) low back pain (LBP) and/or sciatica.
Abnormalities of intervertebral disc on magnetic resonance imaging (MRI).

Exclusion criteria

Patients with prior spine surgery.
Vertebral instability.
Cancer.
Current infectious disease.
Pregnancy.
Kinesiophobia.
Fibromyalgia.

Treatment and study plan

Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.)

Device

The patients were positioned in supine with adjustable lumbar, and thoracic belts attached to the traction cord. After tightening the belts, the M7 position was selected to achieve hip and knee flexion, and posterior pelvic tilt of 25° was added. Before starting the therapy, the weight of the subject was entered in the panel, and a short tolerance test was carried out. Patients were provided with a manual switch to stop treatment any time. Preset lumbar disc herniation protocol was used. Each session lasted fifteen minutes, applied force had 100-gram step increments, and did not exceed 50% of the weight of the patient. At the end of the therapy, the cord was disconnected and belts were removed. Participants were asked to sit for three minutes to identify any adverse reaction.

Primary outcomes

Self-reported disability

Time frame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.

We measured self-reported disability associated with spine disorders through the spanish version of the Oswestry Disability Index (ODI), a reliable and validated instrument composed by ten sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling), in which the patient grades the disability from zero (no limitation) to five (limitation prevents me from performing the activity). The ODI final score was calculated with the following formula: [total score/(5 x number of answered questions)] x 100%, and interpreted as the higher the score, the greater the disability.
Pain intensity

Time frame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.

Pain intensity was also evaluated with the numeric pain rating scale (NPRS), a popular clinical tool consisting of a numbered straight line from zero (no pain) to ten (the worst pain), where the patients registered their current pain intensity.

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain and Sciatica: a 2-month Follow-up Study

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Feb 23, 2024
Registry last updated: Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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