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
  Purpose

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.


Condition Intervention Phase
Cumulative Trauma Disorders
Repetitive Strain Injury
Carpal Tunnel Syndrome
Pain
Procedure: Acupuncture
Drug: Amitriptyline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Sham Device, Pill Placebo or Treatment For Arm Pain

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 240
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated for repetitive strain injury for at least 3 months at a clinical site in the Greater Boston Area
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029497

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Cambridge Hospital
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Investigators
Principal Investigator: Ted Kaptchuk, OMD Harvard
  More Information

No publications provided

Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00029497     History of Changes
Other Study ID Numbers: R01 AT000402-01
Study First Received: January 14, 2002
Last Updated: March 21, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries
Amitriptyline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Antidepressive Agents
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014