Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460161
Status:
SUSPENDED
Last Update Posted:
2009-02-18
First Post:
2007-04-12
Brief Title:
Acupuncture for Phantom Limb Pain
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Acupuncture for Phantom Limb Pain A Randomized Double-Blind PlaceboSham - Controlled Study
Status:
SUSPENDED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phantom pain is a common complication following limb amputation and is thought to result from a system of pathophysiological mechanisms - peripheral spinal central and psychological Treatment is primarily medical using antidepressant and anticonvulsant medications At present there is no evidence-based approach for the management of phantom limb pain PLP Acupuncture is an ancient Chinese treatment during which thin needles diameter 020-030mm are inserted into various points on the skin Studies of this treatment have found significant benefit in a number of conditions with chronic pain
We propose a randomized double-blind placebosham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation Patients requiring lower limb amputation above-ankle will be randomized into two groups for real or placebosham acupuncture treatment Both groups will be treated twice-weekly with a standardized as opposed to individualized acupuncture treatment protocol using either true or placebo needles at sham acupuncture points for a period of four weeks eight treatments
The primary outcome to be evaluated will be PLP at 4 weeks using a site-specific numerical rating pain scale ss-NRS Secondary outcome measures to be evaluated are stump pain ss-NRS analgesic use Tramadol 100mg Tablet and depressive symptoms using the Beck Depression Score Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period
We propose a randomized double-blind placebosham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation Patients requiring lower limb amputation above-ankle will be randomized into two groups for real or placebosham acupuncture treatment Both groups will be treated twice-weekly with a standardized as opposed to individualized acupuncture treatment protocol using either true or placebo needles at sham acupuncture points for a period of four weeks eight treatments
The primary outcome to be evaluated will be PLP at 4 weeks using a site-specific numerical rating pain scale ss-NRS Secondary outcome measures to be evaluated are stump pain ss-NRS analgesic use Tramadol 100mg Tablet and depressive symptoms using the Beck Depression Score Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period
Detailed Description:
None
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