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

Hospital Civil de Guadalajara

Status: Completed

Conditions: Lumbar Disc Herniation; Sciatica; Low Back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06275750

CEI 175/23

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Patients treated with non-surgical spinal decompression

Experimental group

Description:

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.

Treatment:

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