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The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

NCT ID: NCT00703248

Last Updated: 2008-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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Human Immunodeficiency Virus (HIV) complementary therapies

Study Design

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Primary Study Purpose

SUPPORTIVE_CARE

Study Groups

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1

Group Type EXPERIMENTAL

Osteopathic Manipulative Treatments

Intervention Type PROCEDURE

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.

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Locations

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Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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HPD-OST10030701

Identifier Type: -

Identifier Source: org_study_id