Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000817
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-infected patients
Both amitriptyline an antidepressant and acupuncture a Chinese medical approach that uses needles to relieve pain have been used successfully to reduce pain in some people It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection
Both amitriptyline an antidepressant and acupuncture a Chinese medical approach that uses needles to relieve pain have been used successfully to reduce pain in some people It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection
Detailed Description:
Both amitriptyline an antidepressant and acupuncture a Chinese medical approach that uses needles to relieve pain have been used successfully to reduce pain in some people It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection
Patients are randomized to receive either standardized point acupuncture or alternate point acupuncture treatment twice weekly for the first 6 weeks then once weekly for the next 8 weeks plus either oral amitriptyline or placebo daily for the entire 14 weeks Acupuncture points are located on the lower leg Patients are evaluated at weeks 6 and 14 and are asked to keep a daily pain diary
Patients are randomized to receive either standardized point acupuncture or alternate point acupuncture treatment twice weekly for the first 6 weeks then once weekly for the next 8 weeks plus either oral amitriptyline or placebo daily for the entire 14 weeks Acupuncture points are located on the lower leg Patients are evaluated at weeks 6 and 14 and are asked to keep a daily pain diary
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 |
|---|---|---|---|
| 11572 | REGISTRY | DAIDS ES Registry Number | None |