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

Not Applicable

Completed

• Conditions: Sciatica; Low Back Pain; Lumbar Disc Herniation

• Registration Number: NCT06275750
• Lead Sponsor: Hospital Civil de Guadalajara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Primary Completion: 2023-11-29
• Study Completion: 2024-01-11
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain intensity	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.
Self-reported disability	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.

Trial Locations

Locations (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico