Status:
TERMINATED
Chiropractic Prone Distraction for Lower Back Pain
Lead Sponsor:
Samueli Institute for Information Biology
Collaborating Sponsors:
National Naval Medical Center
Conditions:
Herniated Disc
Lower Back Pain
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00269503
Start Date
March 1 2006
End Date
June 1 2006
Last Update
May 8 2008
Active Locations (1)
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1
National Naval Medical Center
Bethesda, Maryland, United States, 20889