Sham Device, Pill Placebo or Treatment For Arm Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00029497
First received: January 14, 2002
Last updated: March 21, 2013
Last verified: March 2013

January 14, 2002
March 21, 2013
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June 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00029497 on ClinicalTrials.gov Archive Site
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Sham Device, Pill Placebo or Treatment For Arm Pain
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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
  • Cumulative Trauma Disorders
  • Repetitive Strain Injury
  • Carpal Tunnel Syndrome
  • Pain
  • Procedure: Acupuncture
  • Drug: Amitriptyline
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated for repetitive strain injury for at least 3 months at a clinical site in the Greater Boston Area
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029497
R01 AT000402-01
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Ted Kaptchuk, OMD Harvard
National Center for Complementary and Alternative Medicine (NCCAM)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP