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

Chronic Pain Clinical Trial

— SIMTAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186341
• Other study ID #: Pro00018346
• Status: Completed
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
United States	University of Maryland Center for Integrative Medicine	Baltimore	Maryland
United States	Alliance Center for Integrative Medicine	Cincinnati	Ohio
United States	Duke Integrative Medicine	Durham	North Carolina
United States	Scripps Center for Integrative Medicine	La Jolla	California
United States	Penny George Institute for Health and Healing	Minneapolis	Minnesota
United States	The Continuum Center for Health and Healing	New York	New York
United States	Jefferson-Myrna Brind Center of Integrative Medicine	Philadelphia	Pennsylvania
United States	UCSF Osher Center for Integrative Medicine	San Francisco	California
United States	Venice Family Clinic Simms/Mann Health and Wellness Center	Santa Monica	California

Sponsors (10)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life	As measured by self report on a questionnaire	24 weeks
Secondary	Sense of control	As measured by a Visual Analog Scale	24 weeks
Secondary	Depression and Stress	As measured by self report questionnaires such as the depression (The Center for Epidemiologic Studies Depression Scale (CES-D)and stress (The Perceived Stress Scale - 4)	24 weeks
Secondary	Inflammatory Marker and Vitamin D	High-sensitivity C reactive protein (hs-CRP) and 25-hydroxy-vitamin D levels at baseline and 12 weeks	24 weeks
Secondary	Health services utilization	As measured by self report of health services(including medications and supplements).	24 weeks
Secondary	Work productivity and activity impairment	As measured by the Work Productivity and Activity Impairment (WPAI) survey.	24 weeks
Secondary	Estimate the effect size of IM interventions for reducing pain in chronic pain patients	As measured by the Pain-Visual analog scale of average and worst pain and (total) Brief Pain Inventory (BPI) interference scale	24 weeks