This application is based on observations that the magnitude of the placebo effect produced by a device is greater than that produced by a pill. If this is generally true, there are significant implications for the design of clinical trials involving medical devices and for our understanding of the role of the placebo effect in randomized controlled trials (RCT). This is a two phase study. In the first phase, the investigators will estimate the relative magnitudes of placebo effects associated with a sham acupuncture procedure versus an inactive oral treatment in patients with persistent upper extremity pain secondary to repetitive strain injury (RSI) most notably, carpal tunnel syndrome (CTS). In the second phase, parallel RCTs of traditional Chinese acupuncture (TCA) and low-dose amitriptyline (AMI) versus their respective placebo treatments will be conducted. In Phase I, 240 patients with RSI will be randomly assigned to receive a placebo device (a recently validated sham acupuncture device) or a placebo pill (dummy AMI). The primary hypothesis in Phase I is that patients will respond better to the sham device than the placebo pill. Phase II will see patients in each arm of Phase I randomly assigned to active or inactive treatment. Patients from the sham acupuncture arm of Phase I will receive either TCA or continue to receive the sham version. Patients in the placebo pill arm of Phase I will receive either AMI or continue receiving the placebo pill. Outcomes in these studies will include assessments of the nature and severity of upper extremity pain, function, grip and pinch strength, and mood.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project (R01)
Project #
7R01AT000402-03
Application #
6609839
Study Section
Special Emphasis Panel (ZRG1-RPHB-3 (01))
Program Officer
Klein, Marguerite
Project Start
2000-09-01
Project End
2003-06-30
Budget Start
2002-03-01
Budget End
2002-06-30
Support Year
3
Fiscal Year
2001
Total Cost
$239,842
Indirect Cost
Name
Harvard University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
082359691
City
Boston
State
MA
Country
United States
Zip Code
02115
Kaptchuk, Ted J; Friedlander, Elizabeth; Kelley, John M et al. (2010) Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 5:e15591
Goldman, Rose H; Stason, William B; Park, Sung Kyun et al. (2010) Low-dose amitriptyline for treatment of persistent arm pain due to repetitive use. Pain 149:117-23
Goldman, Rose H; Stason, William B; Park, Sung Kyun et al. (2008) Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial. Clin J Pain 24:211-8
McManus, Claire A; Kaptchuk, Ted J; Schnyer, Rosa N et al. (2007) Experiences of acupuncturists in a placebo-controlled, randomized clinical trial. J Altern Complement Med 13:533-8
McManus, Claire A; Schnyer, Rosa N; Kong, Jian et al. (2007) Sham acupuncture devices--practical advice for researchers. Acupunct Med 25:36-40
Kaptchuk, Ted J; Stason, William B; Davis, Roger B et al. (2006) Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ 332:391-7
Miller, Franklin G; Kaptchuk, Ted J (2004) Sham procedures and the ethics of clinical trials. J R Soc Med 97:576-8
Kaptchuk, Ted J (2003) Effect of interpretive bias on research evidence. BMJ 326:1453-5
Kaptchuk, Ted J (2002) Acupuncture: theory, efficacy, and practice. Ann Intern Med 136:374-83
Kaptchuk, Ted J (2002) The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med 136:817-25