BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain

NCT01186341 | Completed

• 1 other identifier: Pro00018346
• Study Type: observational
• Target: 418
• Locations: 1 country
• Sites: 9

Brief Summary

Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet Outpatient Clinics indicate that pain was the leading reason for patient visits. As a precursor to a large multi-site clinical trial, this study aims to determine the feasibility of collecting outcomes data on integrative treatment for pain. These preliminary data will also provide an estimation of effect size for powering the multi-site clinical trial.

Conditions

Chronic Pain

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility of assessing the impact of IM intervention on chronic pain

  As measured by the number of patients approached to participate, number who refuse to participate, reasons for refusal, and the number of people who provide consent.

  24 weeks

Secondary Outcomes (7)

• Quality of Life

  24 weeks

• Sense of control

  24 weeks

• Depression and Stress

  24 weeks

• Inflammatory Marker and Vitamin D

  24 weeks

• Health services utilization

  24 weeks

Study Arms (1)

Chronic Pain

New or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic \> 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the Visual Analog Scale.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending one of the nine Integrative Medicine Clinics of the BraveNet research network.

You may qualify if:

• Subjects will be men and women aged 18 and over.
• Patient Status: Participants are eligible if they are new or existing patients of the center who are seeking their initial treatment at the Integrative Medicine center for chronic pain (chronic \> 3 months) who report their average pain level over the past month to be at least a 4 of 10 on the VAS.
• English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent.
• Subject must provide written informed consent before initiation of any study-related procedures.
• Subject must be able to understand and comply with the requirements of the study, as judged by the investigator.

You may not qualify if:

• A subject will not be eligible if he/she is unable to provide Informed Consent.
• Inability to read and write in English or Spanish.
• Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the patients risk by participating in the study.

Sponsors & Collaborators

• Duke University: lead
• The Bravewell Collaborative: collaborator
• Alliance Institute for Integrative Medicine: collaborator
• Allina Health System: collaborator
• University of Maryland: collaborator
• Beth Israel Medical Center: collaborator
• Thomas Jefferson University: collaborator
• University of California, San Francisco: collaborator
• Scripps Clinic: collaborator
• Venice Family Clinic: collaborator

Study Sites (9)

Scripps Center for Integrative Medicine

La Jolla, California, 92037, United States

Location

UCSF Osher Center for Integrative Medicine

San Francisco, California, 94143, United States

Location

Venice Family Clinic Simms/Mann Health and Wellness Center

Santa Monica, California, 90405, United States

Location

University of Maryland Center for Integrative Medicine

Baltimore, Maryland, 21207, United States

Location

Penny George Institute for Health and Healing

Minneapolis, Minnesota, 55407, United States

Location

The Continuum Center for Health and Healing

New York, New York, 10016, United States

Location

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

Alliance Center for Integrative Medicine

Cincinnati, Ohio, 45236, United States

Location

Jefferson-Myrna Brind Center of Integrative Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.

  PMID: 23800144 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rowena Dolor, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Ruth Wolever, PhD

  Duke Integrative Medicine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 26, 2023

Record last verified: 2011-06

Locations

US (9)