NCT06275750

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Low Back Pain
• Sciatica
• Lumbar Disc Herniation

Interventions

Type	Name	Description
DEVICE	Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.)	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.

Timeline

• Start date: 2023-08-21
• Primary completion: 2023-11-29
• Completion: 2024-01-11
• First posted: 2024-02-23
• Last updated: 2025-02-06

Locations

1 site across 1 country: Mexico