Acupuncture for Infectious Mononucleosis Trial (AIM)

July 7, 2022 updated by: University of Alberta
The purpose of this study is to investigate feasibility issues related to conducting an acupuncture study in a population of adolescents and young adults with infectious mononucleosis. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study examines the feasibility of treating adolescents and young adults diagnosed with infectious mononucleosis with acupuncture. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mono diagnosis confirmed by lab test
  • 21 days or less between start of symptoms and diagnostic test
  • presence of fatigue of at least 4/11 (by Chalder Fatigue Questionnaire)
  • no other illnesses present
  • meets residency requirement

Exclusion Criteria:

  • insufficient communication in English
  • unable to begin acupuncture within 21 days of diagnostic test
  • acupuncture use currently or in the preceding 3 months
  • currently under the care of a TCM practitioner
  • unwilling to be randomized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Traditional Chinese acupuncture in conjunction with standard medical care
Procedure: traditional Chinese acupuncture
10 treatments over 6 weeks
Active Comparator: Standard medical care
standard medical care
Other: standard medical care
standard care as provided by primary physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chalder Fatigue Questionnaire
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
MOS SF-36
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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