Low Back PainNCT02729181
Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality
An observational study of Low Back Pain, run by Integrity Life Sciences.
Trial summary
The investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- DRX9000
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Mar 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pain Management Clinic
Who may be able to join
- at least 18 years of age;
- consented to the physician prescribed protocol;
- presented with discogenic low back pain defined as low back pain for minimum of 12 weeks;
- current CT scan
Who cannot join
- metastatic cancer;
- previous spinal fusion or placement of stabilization hardware within 6 months;
- instrumentation or artificial discs;
- neurologic motor deficits, bladder, or sexual dysfunction;
- alcohol or drug abuse
- patient's with extremes of height (< 147 cm or > 203 cm) and body weight (> 136 kg).
About this study
Official title: Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality: A Retrospective Study
The investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.
- Conditions
- Low Back Pain
- Being tested
- DRX9000
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRX9000Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain.
0= no pain; 10=worst pain
Measured: 12-16 weeks
Secondary outcomes (2)
Functional capacity, measured by activities of daily living
Measured: 12-16 weeks
Proportion of patients using adjuvant analgesic medication
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionMar 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrity Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729181
- Sponsor's protocol ID
- Axiom-CA-L1N-8R1
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality: A Retrospective Study
- ClinicalTrials.gov ID
- NCT02729181
- Acronym / sponsor ID
- Axiom-CA-L1N-8R1
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Integrity Life SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Apr 2016 (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 treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pain Management Clinic
Key inclusion criteria (4 listed)
- at least 18 years of age;
- consented to the physician prescribed protocol;
- presented with discogenic low back pain defined as low back pain for minimum of 12 weeks;
- current CT scan
Key exclusion criteria (6 listed)
- metastatic cancer;
- previous spinal fusion or placement of stabilization hardware within 6 months;
- instrumentation or artificial discs;
- neurologic motor deficits, bladder, or sexual dysfunction;
- alcohol or drug abuse
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 |
|---|---|---|
| DRX9000 | Device | – |
Primary outcome
Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain.
Time frame: 12-16 weeks
0= no pain; 10=worst pain
2 secondary outcomes
Functional capacity, measured by activities of daily living
Time frame: 12-16 weeks
Proportion of patients using adjuvant analgesic medication
Time frame: 12-16 weeks
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 Apr 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Integrity Life Sciences.
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 6 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain. (time frame: 12-16 weeks). 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 Apr 2016.