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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonatiuh Avila, MD | Hospital Civil de Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
The data that support the findings of this study are available from the corresponding author, upon reasonable request.
No determined.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D012585 | Sciatica |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D019635 | Neurosurgical Procedures |