Chronic Low Back PainNCT00828880
Restoration of Disc Height Reduces Chronic Low Back Pain
An observational study of Chronic Low Back Pain, run by NEMA Research, Inc. at 1 site in United States.
Trial summary
The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- DRX9000
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- at least 18 years of age;
- consented for the 6 weeks treatment protocol;
- presented with discogenic low back pain of at least 3 out of 10; AND
- current CT scan not older than 2 months.
Who cannot join
- metastatic cancer;
- previous spinal fusion or placement of stabilization hardware;
- instrumentation or artificial discs;
- neurologic motor deficits, bladder, or sexual dysfunction;
- alcohol or drug abuse; OR
- litigation for a health-related claim (in process or pending for workers' compensation or personal injury).
- Limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (< 147 cm or > 203 cm) and body weight (> 136 kg).
Trial locations and contacts
1 site in 1 country.
United States1 site
Upper Valley Interventional Radiology
McAllen, Texas, 78501
About this study
Official title: Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study
The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.
- Conditions
- Chronic Low Back Pain
- Being tested
- DRX9000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRX9000Device
DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period
| Study group | Role | What they receive |
|---|---|---|
| DRX9000 | Not described Receives: Device: DRX9000 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- NEMA Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axiom Worldwide, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828880
- Sponsor's protocol ID
- R-AXW01
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2009
- Last updated
- 26 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155. doi: 10.1186/1471-2474-11-155.
PubMed 20615252
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Disk Height Through Non-Invasive Spinal Decompression is Associated With Decreased Discogenic Low-Back Pain: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT00828880
- Acronym / sponsor ID
- R-AXW01
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- NEMA Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Axiom Worldwide, LLC
- First posted
- 26 Jan 2009 (estimated)
- 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 investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRX9000 | – | Device: DRX9000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- at least 18 years of age;
- consented for the 6 weeks treatment protocol;
- presented with discogenic low back pain of at least 3 out of 10; AND
- current CT scan not older than 2 months.
Key exclusion criteria (7 listed)
- metastatic cancer;
- previous spinal fusion or placement of stabilization hardware;
- instrumentation or artificial discs;
- neurologic motor deficits, bladder, or sexual dysfunction;
- alcohol or drug abuse; OR
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 |
|---|---|---|
| DRX9000DRX9000 - non-invasive spinal decompression. Treatments 28 min 5 x/wk x 2wks, 3x/wk x 2 wks, 2x/wk x 2 wks for a total of 20 treatments in a 6-week period | Device | DRX9000 |
Primary outcome
Not reported in the source record.
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 26 Jan 2009.
- Derived from this study: PubMed 20615252Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155. doi: 10.1186/1471-2474-11-155.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by NEMA Research, Inc. at 1 site in United States.
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 4 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 26 Jan 2009. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828880, which also lists 1 linked publication.
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 26 Jan 2009.