Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010985
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2001-02-02
Brief Title:
Usual Care Vs Choice of Alternative Rx Low Back Pain
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Usual Care Vs Choice of Alternative Rx Low Back Pain
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares two approaches to the management of acute low back pain usual care standard benefit vs the choice of usual care chiropractic acupuncture or massage therapy expanded benefit 480 subjects with uncomplicated acute low back pain will be recruited from a health maintenance organization and randomized to either usual care n160 or choice of expanded benefits n320 Patients preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study Subjects randomized to the expanded benefits arm who choose chiropractic acupuncture or massage will receive up to 10 treatments over a five-week period Additional treatments will be available after the fifth week but will require a copayment Treatments will be provided by licensed providers who have met strict credentialing criteria Chiropractic acupuncture or massage treatments will begin within 48 hours Chiropractic acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit Symptom relief functional status restricted activity days use of health care and patient and provider satisfaction will be assessed at 2 512 26 and 52 weeks after initiation of treatment Primary outcomes will include 1 change in symptoms 2 change in functional status 3 patient satisfaction and 4 total utilization of services associated with care for low back pain Medical records and the HMOs cost management information system will identify use of services It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms a faster return to baseline functional status a decrease in utilization of conventional medical services and will be more satisfied with their care The study is a direct examination of the effectiveness of an insurance eligibility intervention not a test of the efficacy of specific non-allopathic treatment regimens The results of this study will provide valuable information to clinicians patients and third party payers on the relative benefits and costs of an expanded benefits treatment option which incorporates chiropractic acupuncture and massage services for low back pain
Detailed Description:
See brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AT000144-01 | NIH | None | httpsreporternihgovquickSearchR01AT000144-01 |