AIM: Acupuncture for Infectious Mononucleosis Trial

Sponsor

University of Alberta (Other)

Overall Status

Terminated

CT.gov ID

NCT00598988

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Infectious Mononucleosis	Procedure: traditional Chinese acupuncture Other: standard medical care	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Acupuncture for Infectious Mononucleosis Trial

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Chalder Fatigue Questionnaire [12 weeks]

Secondary Outcome Measures

MOS SF-36 [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 2E1

Sponsors and Collaborators

University of Alberta

Investigators

Principal Investigator: Sunita Vohra, MD, MSc, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT00598988

Other Study ID Numbers:

6866

First Posted:

Jan 23, 2008

Last Update Posted:

Jul 11, 2022

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by University of Alberta

infectious mononucleosis, mono, acupuncture

Additional relevant MeSH terms:

Communicable Diseases

Infections

Infectious Mononucleosis

Study Results

No Results Posted as of Jul 11, 2022