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Completed

NCT Number: NCT01186341

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Center for Integrative Medicine, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Quality of Life

    Time frame: 24 weeks

    As measured by self report on a questionnaire

  2. Sense of control

    Time frame: 24 weeks

    As measured by a Visual Analog Scale

  3. Depression and Stress

    Time frame: 24 weeks

    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)

  4. Inflammatory Marker and Vitamin D

    Time frame: 24 weeks

    High-sensitivity C reactive protein (hs-CRP) and 25-hydroxy-vitamin D levels at baseline and 12 weeks

  5. Health services utilization

    Time frame: 24 weeks

    As measured by self report of health services(including medications and supplements).

  6. Work productivity and activity impairment

    Time frame: 24 weeks

    As measured by the Work Productivity and Activity Impairment (WPAI) survey.

  7. Estimate the effect size of IM interventions for reducing pain in chronic pain patients

    Time frame: 24 weeks

    As measured by the Pain-Visual analog scale of average and worst pain and (total) Brief Pain Inventory (BPI) interference scale

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • 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

Registry information

Acronym: SIMTAP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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