Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029497
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2002-01-14
Brief Title:
Sham Device Pill Placebo or Treatment For Arm Pain
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Sham Device Pill Placebo or Treatment For Arm Pain
Status:
COMPLETED
Status Verified Date:
2013-03
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 investigates the role of two active interventions and their placebo effects in randomized control trials The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder including carpal tunnel syndrome The active interventions are amitriptyline and acupuncture The placebo are sham acupuncture device and placebo pill
Detailed Description:
There is evidence that the magnitude of the placebo effect produced by a device is greater than that produced by a pill If this is the case it has significant ramifications for all trials involving devices and for our understanding of the role of the placebo effect in randomized controlled trials RCT This two phase study 1investigates the role of the placebo effect in RCTs and 2conducts two trials of treatments for persistent upper extremity pain secondary to repetitive strain injury RSI including carpel tunnel syndrome In Phase I 240 patients with RSI are randomly assigned to receive a placebo device a recently validated sham acupuncture device or a placebo pill dummy amitriptyline Our primary hypothesis is that patients will respond better to the sham device than the placebo pill A finding that sham acupuncture produces a greater placebo response than a placebo pill has important implications for the interpretation of results in trials that compare devices to sham devices devices to pills and medical management to surgery Phase II randomly assigns patients from the sham acupuncture arm of Phase I to receive either TCA or continue to receive the sham version Patients in the placebo pill arm of Phase I will be randomly assigned to receive either AMI or continue receiving the placebo pill From the patientsperspective the shift in treatment assignment from Phase I to II should not be noticeable Phase II will allow us to test whether the active treatments outperform their respective placebos Both of these treatments have shown promise in small studies but neither has been prospectively studied in a large trial with appropriate controls Because Phase I also functions as a run-in period for Phase II analysis combining both phases will allow us to examine whether a run-in has methodological advantages in a device trial Moreover combined analyses permit testing whether patients level of response to placebo in Phase I affects their response to active treatment Phase II A positive finding here would contribute importantly to our understanding of the role of the placebo in RCTs
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