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The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study (HOME)

This study has been completed.
Sponsor:
Information provided by:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00703248
First received: June 19, 2008
Last updated: July 7, 2008
Last verified: June 2008

June 19, 2008
July 7, 2008
October 2007
June 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00703248 on ClinicalTrials.gov Archive Site
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The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
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Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. However, the efficacy of OMT to boost immune function among people living with HIV has not yet been examined in a controlled study. Our experiment is designed to examine the short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months prior to enrollment in the study.

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Interventional
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Primary Purpose: Supportive Care
HIV Infections
Procedure: Osteopathic Manipulative Treatments
  1. opening the thoracic inlet
  2. pectoral traction for 1 minute bilaterally
  3. rib raising for a total of 4 minutes- 2 minutes on each side of the thoracic spine ]
  4. thoracic pump at a rate of 60 times per minute for a total of 5 minutes bilaterally
  5. abdominal pump at a rate of 30 times per minute for a total of 5 minutes bilaterally.
  • Experimental: 1
    Intervention: Procedure: Osteopathic Manipulative Treatments
  • No Intervention: 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • are either Antiretroviral Therapy (ART) naïve or not have taken ART for the past 12 months
  • are between the ages of 18 to 65
  • have a CD4+ T cell count between 200-700cells/mm3
  • have viral loads less than 100,000 copies/mL
  • do not have any medical condition that limits his ability to participate in this study as defined by his physician (e.g., cancer, blood clotting disorder etc.)
  • are willing to provide informed consent
  • are not using any drugs recreationally
  • are not on prescribed systemic steroids
  • are willing to recruit a friend/partner, aware of the their HIV serostatus, to be trained in OMT techniques and apply it to him daily.

Exclusion Criteria:

  • history of malignancy excluding both squamous cell carcinoma and basal cell carcinoma of the skin and/or any malignancies fully treated and considered cured by the treating physician for at least 1 year
  • aortic aneurism/disease
  • vertebral artery disease
  • carotid artery stenosis/disease
  • abdominal hernias
  • portal hypertension
  • cirrhosis
  • cervical disc disease currently exhibiting radicular symptomatology (i.e. numbness, burning, muscle weakness, etc)
  • infectious mononucleosis in the past 12 weeks,
  • pneumothorax
  • bone disease
  • Participants with a medical access port and/or a noncompliant ribcage will be excluded from the study.
  • The potential causes for ribcage noncompliance include:

    • congestive obstructive pulmonary disorder (COPD)
    • spinal arthritis
    • costochondritis
    • congestive heart failure (CHF)
    • pulmonary edema
    • recent trauma to the ribcage
    • certain connective tissue disease such as Ankylosing Spondylitis
  • There is a risk of abdominal aortic aneurysm (AAA) rupture in participants with AAA and these participants are excluded from the study.
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00703248
HPD-OST10030701
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Mark A Newberry
Nova Southeastern University
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Nova Southeastern University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP