The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

NCT00703248 | Completed

• 1 other identifier: HPD-OST10030701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Human Immunodeficiency Virus (HIV); complementary therapies

Study Arms (2)

1

EXPERIMENTAL

Procedure: Osteopathic Manipulative Treatments

2

NO INTERVENTION

Interventions

Osteopathic Manipulative Treatments 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.

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 8, 2008

Record last verified: 2008-06

Locations

US (1)