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

NCT06275750 | Completed DMC

• 1 other identifier: CEI 175/23
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Sciatica; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Patients treated with non-surgical spinal decompression

EXPERIMENTAL

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.

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

Interventions

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.

Patients treated with non-surgical spinal decompression

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Conditions

Low Back Pain; Sciatica; Intervertebral Disc Displacement

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Tonatiuh Avila, MD

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 23, 2024
• Study Start: August 21, 2023
• Primary Completion: November 29, 2023
• Study Completion: January 11, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No determined.

Locations

ME (1)