An interventional study of Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) in Low Back Pain, Sciatica and Lumbar Disc Herniation, sponsored by Hospital Civil de Guadalajara. Completed at 1 site in Mexico. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Hospital Civil de Guadalajara · Not applicable, Interventional, and Treatment
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:
Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 39 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.)
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.
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.
Time frame: 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.
Time frame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
Plan to share: Yes — The data that support the findings of this study are available from the corresponding author, upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: No determined.
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Nov 2023, 3 months.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 3 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Hospital Civil de Guadalajara