Low Back PainNCT06275750
Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain
A study testing Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) in people with Low Back Pain and Sciatica, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain, Sciatica, Lumbar Disc Herniation
- What is being tested?
- Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteMexico
- Study dates
- 21 Aug 2023to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Patients with prior spine surgery.
- Vertebral instability.
- Cancer.
- Current infectious disease.
- Pregnancy.
- Kinesiophobia.
- Fibromyalgia.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain and Sciatica: a 2-month Follow-up Study
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:
Read more
- 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
- Being tested
- Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.)
- Medical subject headings
- Low Back Pain, Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start21 Aug 2023
- Primary completion29 Nov 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Tonatiuh Avila Garcia, Hospital Civil de Guadalajara
- Investigators
- Tonatiuh Avila, MD, Principal investigator, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275750
- Sponsor's protocol ID
- CEI 175/23
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain and Sciatica: a 2-month Follow-up Study
- ClinicalTrials.gov ID
- NCT06275750
- Acronym / sponsor ID
- CEI 175/23
- Conditions
- Low Back Pain, Sciatica, Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with non-surgical spinal decompression | Experimental | 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- Patients with prior spine surgery.
- Vertebral instability.
- Cancer.
- Current infectious disease.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients treated with non-surgical spinal decompression |
Primary outcome
Self-reported disability
Time frame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
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.
Pain intensity
Time frame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonatiuh Avila, MD principal investigator
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) in people with Low Back Pain and Sciatica, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported disability (time frame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.