Low Back PainSpiDERSNCT00704210
Effectiveness of Mechanical Decompression for Low Back Pain Relief
A study testing SpineMed Table, Cert HealthSciences LLC in people with Low Back Pain, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- SpineMed Table, Cert HealthSciences LLC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific LBP of at least 6 weeks duration with no evidence of underlying disease or anatomic abnormalities,
- Applicants may have pain radiating to their legs.
Who cannot join
- Any episode of Acute LBP within the last 6 weeks or less
- Recent Fractures, less than 8 weeks of any bone
- Tumors of any type including soft tissue tumors, myeloma, malignant or documented tumors of any type
- Gross osteoporosis,
- Spondylolisthesis grade 2 and above,
- Hardware fixation, spine fixation or other boney fusion
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- Obesity as defined by a BMI greater than 35, body weight over 287 pounds,
- Contra-indication for MRJ assessment,
- Pregnancy,
- neurologic deficits,
- bowel or bladder incontinence,
- progressive lower extremity weakness,
- need for narcotic pain medications for other conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.
Read the detailed description
Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.
The study will assess whether a computer-assisted traction treatment [decompression] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed
Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.
To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.
To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.
To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.
- Conditions
- Low Back Pain
- Being tested
- SpineMed Table, Cert HealthSciences LLC
- Keywords
- Low Back Pain
- 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.
SpineMed Table, Cert HealthSciences LLCDevice
For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.
SpineMed Table, Cert HealthSciences LLCDevice
Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B.
| Study group | Role | What they receive |
|---|---|---|
| B | Sham comparator | Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B. Receives: Device: SpineMed Table, Cert HealthSciences LLC |
| A | Experimental | For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied. Receives: Device: SpineMed Table, Cert HealthSciences LLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be measured using a 0-100 visual analog scale.
Measured: 19 weeks
Functional activity will be measured using the Roland Morris activity scale
Measured: 19 weeks
MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment.
Measured: 19 weeks
Secondary outcomes (5)
Physical and social activities and quality of life will be measured with the COOP
Measured: 19 weeks
Functional health will be measured with the SF-36
Measured: 19 weeks
Depression will be measured using the Geriatric Depression Scale (GDS)
Measured: 19 weeks
Treatment satisfaction will be measured using a 5-point Likert scale.
Measured: 19 weeks
Reduction in pain medication usage
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2008 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: Study withdrawn by sponsor
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Grant, State University of New York - Upstate Medical University
- Investigators
- William D Grant, EdD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704210
- Sponsor's protocol ID
- IRBPHS 5379
- Acronym
- SpiDERS
- Status last verified
- Oct 2016
- First submitted
- 20 Jun 2008
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mechanical Decompression for Low Back Pain Relief
- ClinicalTrials.gov ID
- NCT00704210
- Acronym / sponsor ID
- SpiDERS / IRBPHS 5379
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 24 Jun 2008 (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.
Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.
Detailed description
Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.
The study will assess whether a computer-assisted traction treatment [decompression] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed
Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.
To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.
To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.
To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Sham comparator | Device: SpineMed Table, Cert HealthSciences LLCGroup B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B. |
| A | Experimental | Device: SpineMed Table, Cert HealthSciences LLCFor Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-specific LBP of at least 6 weeks duration with no evidence of underlying disease or anatomic abnormalities,
- Applicants may have pain radiating to their legs.
Key exclusion criteria (13 listed)
- Any episode of Acute LBP within the last 6 weeks or less
- Recent Fractures, less than 8 weeks of any bone
- Tumors of any type including soft tissue tumors, myeloma, malignant or documented tumors of any type
- Gross osteoporosis,
- Spondylolisthesis grade 2 and above,
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 |
|---|---|---|
| SpineMed Table, Cert HealthSciences LLCFor Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied. | Device | A |
| SpineMed Table, Cert HealthSciences LLCGroup B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B. | Device | B |
Primary outcome
Pain will be measured using a 0-100 visual analog scale.
Time frame: 19 weeks
Functional activity will be measured using the Roland Morris activity scale
Time frame: 19 weeks
MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment.
Time frame: 19 weeks
5 secondary outcomes
Physical and social activities and quality of life will be measured with the COOP
Time frame: 19 weeks
Functional health will be measured with the SF-36
Time frame: 19 weeks
Depression will be measured using the Geriatric Depression Scale (GDS)
Time frame: 19 weeks
Treatment satisfaction will be measured using a 5-point Likert scale.
Time frame: 19 weeks
Reduction in pain medication usage
Time frame: 19 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 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.
William D Grant, EdD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpineMed Table, Cert HealthSciences LLC in people with Low Back Pain, run by State University of New York - Upstate Medical University 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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 18 Oct 2016. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain will be measured using a 0-100 visual analog scale. (time frame: 19 weeks). The study lists 3 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 18 Oct 2016.