Herniated DiscNCT00269503
Chiropractic Prone Distraction for Lower Back Pain
A study testing Prone Distraction, Side-Posture Manipulation and Side-Posture Manipulation & Prone Distraction in people with Herniated Disc and Lower Back Pain, run by Samueli Institute for Information Biology at 1 site in United States.
Trial summary
Back pain is a major cause of disability in the United States. The lifetime prevalence of low back pain is estimated at 60-90%. Back pain has conservatively been estimated to involve total direct and indirect costs of over $25 billion annually in lost wages, treatment, and related issues. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Herniated Disc, Lower Back Pain, Sciatica
- What is being tested?
- Prone Distraction, Side-Posture Manipulation and Side-Posture Manipulation & Prone Distraction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2006
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active Duty military personnel
- Aged 18-45 (age is limited to 45 years due to the natural aging and degeneration of the discs; the less hydration the disc maintain, the less likely manipulation will be successful).
- Have subacute low back pain (more than three months duration but less than six months duration), with radicular component (sciatica) rated at a minimum level of 4 on the Numerical Rating Scale (NRS) of the Brief Pain Inventory
- Have a confirmed herniated disc, as noted on MRI, which correlates with the clinical findings (sciatica)
- In this study, a "herniated disc" refers to any localized displacement of disc material, including nucleus, cartilage, fragmented apophyseal bone, or fragmented anular tissue, which results in back and leg pain. "Herniated Disc" also will include disc extrusions and disc bulges (protrusions) only when with associated annular tears.
- In this study, "sciatica" refers to pain in the lower extremity/ies that follows the course of the sciatic nerve
Who cannot join
- Patients who are not able to give informed consent.
- Pregnant or nursing women
- Patients who have a primary bone disease, cancer, infection, spondylolysis or spondylolisthesis.
- Patients who have had prior spine surgery, including rhizotomy
- Participation in another conflicting research study
- Patients who cannot commit to a trial lasting up to eight weeks or cannot come for bi-weekly treatments
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- Patients who are going through a course of physical therapy or chiropractic treatment or at the time of planned enrollment or are being currently being managed and/or treated for any pain condition
- Patients who have an unstable medical or psychiatric condition
- Patients who are planning or have been advised to have spine surgery
- Any contraindications to either prone distraction or side posture manipulation will disqualify potential subjects from any participation in this study
- Patients with a pacemaker.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Naval Medical Center
Bethesda, Maryland, 20889
About this study
Official title: A Pilot Study of Chiropractic Prone Distraction for Subacute Back Pain With Sciatica
Back pain is a major cause of disability in the United States. The lifetime prevalence of low back pain is estimated at 60-90%. Back pain has conservatively been estimated to involve total direct and indirect costs of over $25 billion annually in lost wages, treatment, and related issues. These losses clearly extend to the active duty population cared for by military health care facilities.
Chiropractic medicine is characterized by the use of a number of physical manipulations and mobilization techniques, which can be used singly or in combination to treat a variety of medical conditions. Although basic clinical practice guidelines for Chiropractic have been developed, few studies have rigorously compared techniques and their outcomes for specific conditions. Fewer still have sought to correlate treatment modality with both anatomical effect and clinical outcome.
Read more
Throughout the military, Chiropractic care is available only to active duty personnel and only at a limited number of medical treatment facilities. At National Naval Medical Center, it is a well-established treatment option, where the full array of techniques is employed, primarily for painful conditions, and most often for back pain. This study seeks to clarify the mechanisms of action and efficacy of one specific treatment option, prone distraction, for the relief of subacute sciatica due to radiographically confirmed herniated disc, and to compare it to side-posture manipulation and standard medical management.
Prone lumbar distraction utilizes a specialized table with motorized continual motion distraction. This table has multiple mechanical articulations that can be used to place patients in a wide variety of positions. Patients being treated with continuous motion distraction are placed prone with the table positioned for maximum comfort and centralization of symptoms.
Side posture manipulation is a widely practiced, standard chiropractic technique, which has been shown to provide considerable clinical improvement for patients with sciatica. Low- grade oscillatory stresses are performed within the physiological range of normal joint motion. The hip, pelvis and lumbar spine are rotated forward with manual pressure while a counter rotation of the chest and thoracic spine is applied.
- Conditions
- Herniated Disc, Lower Back Pain, Sciatica
- Being tested
- Prone Distraction, Side-Posture Manipulation, Side-Posture Manipulation & Prone Distraction, Usual Care (Control Group)
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone DistractionProcedure or surgery
Side-Posture ManipulationProcedure or surgery
Side-Posture Manipulation & Prone DistractionProcedure or surgery
Usual Care (Control Group)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall leg pain intensity, as assessed by the change, if any, of leg pain documented on the Numerical Rating Scale (NRS) in the Brief Pain Inventory (BPI) from baseline to 8 weeks
Time to pain relief, defined as NRS less than 4 after 2 consecutive visits
Secondary outcomes (10)
Change in overall back pain intensity, as assessed by the change, if any, of back pain documented on the BPI from baseline to 8 weeks
Change in overall pain intensity, as assessed by the change, if any, of the sum of back and leg pain documented on the BPI at measured intervals
Change in overall pain intensity, as assessed by the change, if any, of the sum of back and leg pain documented on the BPI from baseline to 8 weeks
Patient satisfaction with treatment, as assessed by The Client Satisfaction Questionnaire
Medication use, as assessed by the Medication Log
Functional disability, as assessed by The Roland-Morris Low Back Pain and Disability Questionnaire
Lost/decreased workdays
Change, if any, in percent of disc herniation, as determined by the study neuroradiologist
Descriptive changes in disc morphology, as assessed by the study neuroradiologist
Variability of treatment, as assessed by the number or prescriptions written, the number of visits to the Primary Care Clinic, as well as the number of referrals to additional treatments outside of the chiropractic clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startMar 2006
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- National Naval Medical Center
- Investigators
- William E Morgan, DC, Principal investigator, National Naval Medical CenterCDR Robert E Rosenbaum, MC, USN, Principal investigator, National Naval Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269503
- Sponsor's protocol ID
- #B04-091
- Status last verified
- May 2008
- First submitted
- 21 Dec 2005
- Last updated
- 8 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Chiropractic Prone Distraction for Subacute Back Pain With Sciatica
- ClinicalTrials.gov ID
- NCT00269503
- Acronym / sponsor ID
- #B04-091
- Conditions
- Herniated Disc, Lower Back Pain, Sciatica
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- National Naval Medical Center
- Study start
- Mar 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 23 Dec 2005 (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.
Back pain is a major cause of disability in the United States. The lifetime prevalence of low back pain is estimated at 60-90%. Back pain has conservatively been estimated to involve total direct and indirect costs of over $25 billion annually in lost wages, treatment, and related issues. These losses clearly extend to the active duty population cared for by military health care facilities.
Chiropractic medicine is characterized by the use of a number of physical manipulations and mobilization techniques, which can be used singly or in combination to treat a variety of medical conditions. Although basic clinical practice guidelines for Chiropractic have been developed, few studies have rigorously compared techniques and their outcomes for specific conditions. Fewer still have sought to correlate treatment modality with both anatomical effect and clinical outcome.
Throughout the military, Chiropractic care is available only to active duty personnel and only at a limited number of medical treatment facilities. At National Naval Medical Center, it is a well-established treatment option, where the full array of techniques is employed, primarily for painful conditions, and most often for back pain. This study seeks to clarify the mechanisms of action and efficacy of one specific treatment option, prone distraction, for the relief of subacute sciatica due to radiographically confirmed herniated disc, and to compare it to side-posture manipulation and standard medical management.
Prone lumbar distraction utilizes a specialized table with motorized continual motion distraction. This table has multiple mechanical articulations that can be used to place patients in a wide variety of positions. Patients being treated with continuous motion distraction are placed prone with the table positioned for maximum comfort and centralization of symptoms.
Side posture manipulation is a widely practiced, standard chiropractic technique, which has been shown to provide considerable clinical improvement for patients with sciatica. Low- grade oscillatory stresses are performed within the physiological range of normal joint motion. The hip, pelvis and lumbar spine are rotated forward with manual pressure while a counter rotation of the chest and thoracic spine is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Active Duty military personnel
- Aged 18-45 (age is limited to 45 years due to the natural aging and degeneration of the discs; the less hydration the disc maintain, the less likely manipulation will be successful).
- Have subacute low back pain (more than three months duration but less than six months duration), with radicular component (sciatica) rated at a minimum level of 4 on the Numerical Rating Scale (NRS) of the Brief Pain Inventory
- Have a confirmed herniated disc, as noted on MRI, which correlates with the clinical findings (sciatica)
- In this study, a "herniated disc" refers to any localized displacement of disc material, including nucleus, cartilage, fragmented apophyseal bone, or fragmented anular tissue, which results in back and leg pain. "Herniated Disc" also will include disc extrusions and disc bulges (protrusions) only when with associated annular tears.
Key exclusion criteria (11 listed)
- Patients who are not able to give informed consent.
- Pregnant or nursing women
- Patients who have a primary bone disease, cancer, infection, spondylolysis or spondylolisthesis.
- Patients who have had prior spine surgery, including rhizotomy
- Participation in another conflicting research study
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 |
|---|---|---|
| Prone Distraction | Procedure or surgery | – |
| Side-Posture Manipulation | Procedure or surgery | – |
| Side-Posture Manipulation & Prone Distraction | Procedure or surgery | – |
| Usual Care (Control Group) | Procedure or surgery | – |
Primary outcome
Change in overall leg pain intensity, as assessed by the change, if any, of leg pain documented on the Numerical Rating Scale (NRS) in the Brief Pain Inventory (BPI) from baseline to 8 weeks
Time to pain relief, defined as NRS less than 4 after 2 consecutive visits
10 secondary outcomes
Change in overall back pain intensity, as assessed by the change, if any, of back pain documented on the BPI from baseline to 8 weeks
Change in overall pain intensity, as assessed by the change, if any, of the sum of back and leg pain documented on the BPI at measured intervals
Change in overall pain intensity, as assessed by the change, if any, of the sum of back and leg pain documented on the BPI from baseline to 8 weeks
Patient satisfaction with treatment, as assessed by The Client Satisfaction Questionnaire
Medication use, as assessed by the Medication Log
Functional disability, as assessed by The Roland-Morris Low Back Pain and Disability Questionnaire
Lost/decreased workdays
Change, if any, in percent of disc herniation, as determined by the study neuroradiologist
Descriptive changes in disc morphology, as assessed by the study neuroradiologist
Variability of treatment, as assessed by the number or prescriptions written, the number of visits to the Primary Care Clinic, as well as the number of referrals to additional treatments outside of the chiropractic clinic
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2008.
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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 E Morgan, DC principal investigator
National Naval Medical Center
CDR Robert E Rosenbaum, MC, USN principal investigator
National Naval Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Distraction, Side-Posture Manipulation and Side-Posture Manipulation & Prone Distraction in people with Herniated Disc and Lower Back Pain, run by Samueli Institute for Information Biology 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 6 inclusion and 11 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 May 2008. 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. 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?
Change in overall leg pain intensity, as assessed by the change, if any, of leg pain documented on the Numerical Rating Scale (NRS) in the Brief Pain Inventory (BPI) from baseline to 8 weeks. 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 8 May 2008.