RadiculopathyNCT01236092
Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
A study testing conservative therapy - traction, vibration, exercise in people with Radiculopathy and Low Back Pain, run by Michael Wilson & Associates Health Care Consulting, LLC at 1 site in United States.
Trial summary
The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Radiculopathy, Low Back Pain
- What is being tested?
- conservative therapy - traction, vibration, exercise
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI of the lumbar spine showing symptoms and severity to qualify for surgery
- 25 to 65 years of age
- Diagnosis of low back pain for 3-12 months
- Potential surgical candidates but not mandatory
Who cannot join
- any medical or physical conditions deemed unacceptable by the participants physician or health care provider
- Evidence of progressive or debilitative medical conditions i.e. metastatic cancer, major stroke, crippling arthritis, unstable angina, orthostatic hypotension, hemiplegia, multiple sclerosis or Parkinson's disease.
- Any condition that would preclude the additional burden of a repeat MRI or preclude active involvement in the protocol or physical therapy
- Active use of tobacco products
- Prior back surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Rhabilitation Institute and Revita Back
Spokane, Washington, 99204
About this study
Official title: Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.
The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Whole-body vibration combined with un-weighting traction and specific manual mobilization plus active therapeutic exercise seems to treat chronic low back pain by non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such therapy reduces the need for surgery and significantly out performs traditional physical as the preferred conservative treatment.
Read the detailed description
Patients will be placed randomly in the control group and will receive 10 weeks of standard physical therapy or in the study group and receive an equivalent 10 weeks therapy utilizing vibration, unweighting, therapeutic exercise and manual mobilization. The study uses a baseline MRI and x-rays which have shown the justification for surgical intervention and during the course of the protocol will have repeat MRI's and x-rays to determine any statistical change in the lumbar spine resulting in reduction or elimination of pain, improved range of motion, improvements in performance and reduction or elimination for the need for surgical intervention. Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions,disc height, canal stenosis, lumbosacral angle and facet spacing. Questionnaires will be completed during the course of the treatment and post-treatment at 6 months and one year. The final follow up phone call to the patient will be made following 24 months post initial treatment to determine the current patient status pertaining to low back pain, subsequent treatment, surgery, etc. Final study documentation will occur at that time. Intermediate results at one year will compare the control group vs. the study group for overall result differences.
- Conditions
- Radiculopathy, Low Back Pain
- Being tested
- conservative therapy - traction, vibration, exercise
- Keywords
- resolution of low back pain, show measurable improvement in disc measurement, conservative therapy vs. surgery in resolving low back pain
- Medical subject headings
- Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative therapy - traction, vibration, exerciseOther
10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic changes in the low back
Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions, disc height, canal stenosis, lumbrosacral angle, and facet spacing.
Measured: 6 months following enrollment
Secondary outcomes (1)
determine the percentage of patients who do not obtain relief of symptoms from either therapy and move on to surgery and determine the statistical difference between therapies.
The comparison of convervative therapies, the control group with standard physical therapy and the study group, serve as the comparitive for the success as measured by the number from each group which move to surgery within the one year.
Measured: one year following initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionDec 2013
Why it stopped: Inadequate patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Wilson & Associates Health Care Consulting, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pneumex Corporation
- Responsible party
- Sponsor
- Investigators
- Dean Martz, m.d., Principal investigator, Inland Neurosurgery and Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236092
- Sponsor's protocol ID
- mwilson consulting, llc
- Status last verified
- Jul 2012
- First submitted
- 4 Nov 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.
- ClinicalTrials.gov ID
- NCT01236092
- Acronym / sponsor ID
- mwilson consulting, llc
- Conditions
- Radiculopathy, Low Back Pain
- Keywords
- resolution of low back pain, show measurable improvement in disc measurement, conservative therapy vs. surgery in resolving low back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate patient enrollment
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Michael Wilson & Associates Health Care Consulting, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pneumex Corporation
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Nov 2010 (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 most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Whole-body vibration combined with un-weighting traction and specific manual mobilization plus active therapeutic exercise seems to treat chronic low back pain by non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such therapy reduces the need for surgery and significantly out performs traditional physical as the preferred conservative treatment.
Detailed description
Patients will be placed randomly in the control group and will receive 10 weeks of standard physical therapy or in the study group and receive an equivalent 10 weeks therapy utilizing vibration, unweighting, therapeutic exercise and manual mobilization. The study uses a baseline MRI and x-rays which have shown the justification for surgical intervention and during the course of the protocol will have repeat MRI's and x-rays to determine any statistical change in the lumbar spine resulting in reduction or elimination of pain, improved range of motion, improvements in performance and reduction or elimination for the need for surgical intervention. Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions,disc height, canal stenosis, lumbosacral angle and facet spacing. Questionnaires will be completed during the course of the treatment and post-treatment at 6 months and one year. The final follow up phone call to the patient will be made following 24 months post initial treatment to determine the current patient status pertaining to low back pain, subsequent treatment, surgery, etc. Final study documentation will occur at that time. Intermediate results at one year will compare the control group vs. the study group for overall result differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MRI of the lumbar spine showing symptoms and severity to qualify for surgery
- 25 to 65 years of age
- Diagnosis of low back pain for 3-12 months
- Potential surgical candidates but not mandatory
Key exclusion criteria (6 listed)
- any medical or physical conditions deemed unacceptable by the participants physician or health care provider
- Evidence of progressive or debilitative medical conditions i.e. metastatic cancer, major stroke, crippling arthritis, unstable angina, orthostatic hypotension, hemiplegia, multiple sclerosis or Parkinson's disease.
- Any condition that would preclude the additional burden of a repeat MRI or preclude active involvement in the protocol or physical therapy
- Active use of tobacco products
- Prior back surgery
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 |
|---|---|---|
| conservative therapy - traction, vibration, exercise10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks. | Other | – |
Primary outcome
Radiographic changes in the low back
Time frame: 6 months following enrollment
Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions, disc height, canal stenosis, lumbrosacral angle, and facet spacing.
1 secondary outcome
determine the percentage of patients who do not obtain relief of symptoms from either therapy and move on to surgery and determine the statistical difference between therapies.
Time frame: one year following initiation of therapy
Results and safety
The study was stopped early (reason given: Inadequate patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Dean Martz, m.d. principal investigator
Inland Neurosurgery and Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative therapy - traction, vibration, exercise in people with Radiculopathy and Low Back Pain, run by Michael Wilson & Associates Health Care Consulting, LLC 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 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: stopped early, as of the sponsor's last update on 8 Apr 2015. 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 was stopped early (reason given: Inadequate patient enrollment). Results are not available in the source record.
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?
Radiographic changes in the low back (time frame: 6 months following enrollment). 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 8 Apr 2015.