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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06275750
• Other study ID #: CEI 175/23
• Status: Completed
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: February 2024
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 11, 2024
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Displacement
• Low Back Pain
• Lumbar Disc Herniation
• Sciatica

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported disability	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.	Baseline, at the end of the eighth session, and at 2nd-month follow-up.
Primary	Pain intensity	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.	Baseline, at the end of the eighth session, and at 2nd-month follow-up.