 |
 |
Clinical Trial Name - Elderly Back Pain: Comparing Chiropractic to Medical Care
| Original Study ID : R18HP01423 |
| NCT ID : NCT00602901 |
| Brief Title : Elderly Back Pain: Comparing Chiropractic to Medical Care |
| Official Title : Elderly Back Pain: Comparing Chiropractic to Medical Care |
| Brief Summary : The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic low back pain (LBP). |
| Source : Palmer College of Chiropractic |
| Detailed Description : Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with pack pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain. |
| Overall Status : Completed |
| Start Date : July 2004 |
| End Date : March 2007 |
| Completion Date : March 2007 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Enrollment : 240 |
| Verification Date : September 2008 |
| First Received Date : January 15, 2008 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Age 55 or older - Idiopathic low back pain (LBP) of at least four weeks duration - Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders Exclusion Criteria: - Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis. - Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse. - Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition - Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal maniuplative therapy of the arthropathies and significant osteoporosis - Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory - Current or pending litigation related to current episode of LBP. - Receiving disability for any health-related condition - Spinal Manipulative care for any reason within the past month - Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period. - Unable to read or verbally comprehend English. |
| Gender : Both |
| Minimum Age : 55 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Palmer Center for Chiropractic Research |
| City : Davenport |
| State : Iowa |
| Zip Code : 52803 |
| Country : United States |
| Facility Name : The University of Iowa |
| City : Iowa City |
| State : Iowa |
| Zip Code : 52242 |
| Country : United States |
| Facility Name : Palmer Center for Chiropractic Research |
| City : Davenport |
| State : Iowa |
| Zip Code : 52803 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Roland Morris Disability Questionnaire(RMDQ). |
| Time Frame : 6 weeks |
| Safety issue : No |
| Secondary OutComes |
| Measure : Fear Avoidance Beliefs Questionnaire, physical subscale |
| Time Frame : 6 weeks, 3 months, 6 months |
| Safety issue : No |
| Measure : Visual Analogue Scale for Pain |
| Time Frame : 6 weeks |
| Safety issue : No |
| Measure : Postural Sway |
| Time Frame : 6 weeks |
| Safety issue : No |
| Measure : SF-36, v1, Physical Function subscale |
| Time Frame : 6 weeks |
| Safety issue : No |
| Measure : Posteroanterior Spinal Stiffness |
| Time Frame : 6 weeks |
| Safety issue : No |
| Measure : Sit-to-Stand Maneuver |
| Time Frame : 6 weeks |
| Safety issue : No |
| Measure : Spinal Manipulation |
| Time Frame : 6 weeks |
| Safety issue : No |
| Interventions |
| Type : Other |
| Name : Spinal manipulation |
| Description : High-velocity low amplitude spinal manipulation (HVLA-SM) |
| Type : Other |
| Name : Spinal manipulation |
| Description : Low-velocity variable amplitude spinal manipulation (LVVA-SM) |
| Type : Drug |
| Name : Usual medical care (Celebrex, Aleve, Bextra, Naproxen) |
| Description : Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks. |
Search For Specialist
Types of Treatments
| Search Trials By |
| Research |
| Most Popular Trials |
| Library |
| Discuss |