Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bei-Hung Chang, Boston University
ClinicalTrials.gov Identifier:
NCT00545623
First received: October 15, 2007
Last updated: August 31, 2014
Last verified: August 2014
Results First Received: July 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Procedure: Acupuncture
Behavioral: Relaxation Response
Other: sham acupuncture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
ACUP+RR

acupuncture + relaxation response CD

Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

SHAM+RR

sham acupuncture + relaxation response CD

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

ACUP+EDU

acupuncture+education CD

Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

SHAM+EDU

sham acupuncture+education CD

sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks


Participant Flow:   Overall Study
    ACUP+RR     SHAM+RR     ACUP+EDU     SHAM+EDU  
STARTED     32     31     33     34  
COMPLETED     25     21     20     23  
NOT COMPLETED     7     10     13     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 15 patients did not start the intervention after enrollment, 1, 4, 6, and 4 patients in ACUP+RR, SHAM+RR, ACUP+EDU, and SHAM+EDU arms respectively. As such there are a total of 115 patients with baseline data.

Reporting Groups
  Description
ACUP+RR

acupuncture + relaxation response CD

Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

SHAM+RR

sham acupuncture + relaxation response CD

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

ACUP+EDU

acupuncture+education CD

Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

SHAM+EDU

sham acupuncture+education CD

sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Total Total of all reporting groups

Baseline Measures
    ACUP+RR     SHAM+RR     ACUP+EDU     SHAM+EDU     Total  
Number of Participants  
[units: participants]
  31     27     27     30     115  
Age  
[units: years]
Mean ± Standard Deviation
  47.2  ± 8.8     45.0  ± 7.1     47.1  ± 9.9     47.0  ± 8.2     46.6  ± 8.5  
Gender  
[units: participants]
         
Female     9     9     7     9     34  
Male     22     18     20     21     81  
Region of Enrollment  
[units: participants]
         
United States     31     27     27     30     115  



  Outcome Measures

1.  Primary:   Changes in GI Symptom Per Intervention Session   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bei-Hung Chang
Organization: Boston University
phone: 508-856-8959
e-mail: bhchang@bu.edu


Publications of Results:

Responsible Party: Bei-Hung Chang, Boston University
ClinicalTrials.gov Identifier: NCT00545623     History of Changes
Other Study ID Numbers: R21 AT003377-01, R21AT003377-01
Study First Received: October 15, 2007
Results First Received: July 25, 2014
Last Updated: August 31, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board