Official Title: “Sham Device, Pill Placebo or Treatment For Arm Pain”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Placebo Control

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 1)investigates the role of the placebo effect in RCT's and 2)conducts 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 patients'perspective, 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.

Intervention(s) in this Clinical Trial

• Procedure: Acupuncture
• Drug: Amitriptyline

Inclusion Criteria:

• Treated for repetitive strain injury for at least 3 months at a clinical site in the Greater Boston Area

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Center for Complementary and Alternative Medicine (NCCAM)

Overall Clinical Trial Officials and Contacts

Ted Kaptchuk, OMD Principal Investigator Harvard  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00029497

Study ID Number: R01 AT000402-01

ClinicalTrials.gov Identifier: NCT00029497

Health Authority: United States: Federal Government