NCT00029497

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2002

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

First QC Date

January 14, 2002

Last Update Submit

March 21, 2013

Conditions

Cumulative Trauma DisordersRepetitive Strain InjuryCarpal Tunnel SyndromePain

Interventions

AcupuncturePROCEDURE
AmitriptylineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cambridge Hospital

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Cumulative Trauma DisordersCarpal Tunnel SyndromePain

Interventions

Acupuncture TherapyAmitriptyline

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and InjuriesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Ted Kaptchuk, OMD

    Harvard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2002

First Posted

January 15, 2002

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(2)