Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101387
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2005-01-10
Brief Title:
Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Functional Impact of PENS for 65 Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2011-02
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:
The purpose of this study is to determine whether a form of electrical acupuncture called percutaneous electrical nerve stimulation PENS can reduce pain and disability in older adults with chronic low back pain LBP This study will also determine the effects of general conditioning and aerobic exercise GCAE on chronic LBP
Detailed Description:
Each year a significant number of elderly individuals experience at least one episode of LBP When LBP becomes chronic it can lead to functional and emotional impairment increased health care utilization and decreased quality of life Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy however analgesic-associated morbidity in older adults often limits their utility This study will determine the efficacy of PENS treatment a neuroanatomically guided form of electroacupuncture and exercise in reducing pain in older adults with chronic LBP
Participants will be randomly assigned to one of four treatment groups PENS alone PENS placebo PENS plus GCAE or PENS placebo plus GCAE The treatments will be given twice weekly for 6 weeks Pain intensity physical function health care utilization and psychosocial function will be assessed with self-report and performance-based measures These assessments will be conducted at study start immediately after the last treatment session and 6 months after study completion
Participants will be randomly assigned to one of four treatment groups PENS alone PENS placebo PENS plus GCAE or PENS placebo plus GCAE The treatments will be given twice weekly for 6 weeks Pain intensity physical function health care utilization and psychosocial function will be assessed with self-report and performance-based measures These assessments will be conducted at study start immediately after the last treatment session and 6 months after study completion
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 |
|---|---|---|---|
| R01AT000985-01A2 | NIH | None | httpsreporternihgovquickSearchR01AT000985-01A2 |