Clinical trial NCT01186341: BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain
Official title: BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic Pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Bravewell Collaborative
name: Alliance Institute for Integrative Medicine
name: Allina Health System
name: University of Maryland
name: Beth Israel Medical Center
name: Thomas Jefferson University
name: University of California, San Francisco
name: Scripps Clinic
name: Venice Family Clinic
First posted: 2010-08-23
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending one of the nine Integrative Medicine Clinics of the BraveNet research network.

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.

Detailed description: Integrative medicine (IM) provides a comprehensive approach to care in which healing and wellness of the whole person are the foremost goals. IM is not simply complementary and alternative medicine (CAM), but it stresses patient-centered, healing-oriented care that emphasizes the patient-caregiver relationship.

Little is known about the health outcomes of patients who present to an IM center and undergo a variety of treatment modalities to treat a specific condition. Adequately capturing and describing IM patient outcomes is a challenge for many reasons. First, given the whole person focus of IM, multiple domains of outcomes must be considered including physical, psychological, social, and spiritual. Second, since the patient-centric notion of individualized care is seminal to IM, IM outcomes must allow for patient-reported outcomes. Finally, the complexity of whole system care creates a natural barrier when measuring IM efficacy. Whole systems of care theoretically rely on synergistic and inseparable components and conceptualize the patient-practitioner interaction as a key component of care.

The Bravewell Integrative Medicine Research Network (BraveNet) is a practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of IM. These centers may differ in terms of patient population, medical conditions seen, IM services offered, and treatment outcomes, but all are committed to the provision of integrative care.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To evaluate the feasibility of assessing the impact of IM intervention on chronic pain
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 24 weeks
measure: Sense of control
timeFrame: 24 weeks
measure: Depression and Stress
timeFrame: 24 weeks
measure: Inflammatory Marker and Vitamin D
timeFrame: 24 weeks
measure: Health services utilization
timeFrame: 24 weeks
measure: Work productivity and activity impairment
timeFrame: 24 weeks
measure: Estimate the effect size of IM interventions for reducing pain in chronic pain patients
timeFrame: 24 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Center for Integrative Medicine
state: California
city: San Francisco
country: United States
facility: UCSF Osher Center for Integrative Medicine
state: California
city: Santa Monica
country: United States
facility: Venice Family Clinic Simms/Mann Health and Wellness Center
state: California
city: Baltimore
country: United States
facility: University of Maryland Center for Integrative Medicine
state: Maryland
city: Minneapolis
country: United States
facility: Penny George Institute for Health and Healing
state: Minnesota
city: New York
country: United States
facility: The Continuum Center for Health and Healing
state: New York
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Alliance Center for Integrative Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson-Myrna Brind Center of Integrative Medicine
state: Pennsylvania
Study officials:
affiliation: Duke Clinical Research Institute
name: Rowena Dolor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Integrative Medicine Center
name: Ruth Wolever, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.