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| Descriptive Information Fields | |||||||||
| Brief Title † | Chiropractic Prone Distraction for Lower Back Pain | ||||||||
| Official Title † | A Pilot Study of Chiropractic Prone Distraction for Subacute Back Pain With Sciatica | ||||||||
| 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 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment, Efficacy Study | ||||||||
| 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 Time to pain relief, defined as NRS less than 4 after 2 consecutive visits |
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| Secondary Outcome Measure † | 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 |
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| Condition † | Herniated Disc Lower Back Pain Sciatica |
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| Intervention † | Procedure: Prone Distraction Procedure: Side-Posture Manipulation Procedure: Side-Posture Manipulation & Prone Distraction Procedure: Usual Care (Control Group) |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | 60 | ||||||||
| Start Date † | March 2006 | ||||||||
| Completion Date | June 2006 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
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 Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00269503 | ||||||||
| Organization ID | #B04-091 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Samueli Institute for Information Biology | ||||||||
| Collaborators †† | National Naval Medical Center | ||||||||
| Investigators † |
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| Information Provided By | Samueli Institute for Information Biology | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | December 21, 2005 | ||||||||
| Last Updated Date | May 7, 2008 | ||||||||
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