Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain
NCT ID: NCT06275750
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2023-08-21
2024-01-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients treated with non-surgical spinal decompression
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Chronic (at least six months) low back pain (LBP) and/or sciatica.
* Abnormalities of intervertebral disc on magnetic resonance imaging (MRI).
Exclusion Criteria
* Vertebral instability.
* Cancer.
* Current infectious disease.
* Pregnancy.
* Kinesiophobia.
* Fibromyalgia.
18 Years
55 Years
ALL
No
Sponsors
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Hospital Civil de Guadalajara
OTHER
Responsible Party
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Armando Tonatiuh Avila Garcia
Chief Department of Physical Medicine and Rehabilitation
Principal Investigators
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Tonatiuh Avila, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Civil de Guadalajara
Locations
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Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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Other Identifiers
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CEI 175/23
Identifier Type: -
Identifier Source: org_study_id
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