Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan (Relief)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Arizona
Oregon Health and Science University
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01345409
First received: April 28, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

Recent research examines many types of complementary and alternative (CAM) therapies. However, "real-world" use of CAM has been largely overlooked.

This project consists of four discrete sets of project activities (that largely follow one another chronologically).

Phase1 uses information from the EMR (patient electronic medical records) to identify unique clusters of patients with CMP (chronic musculoskeletal pain), their care within the health plan, and to examine how those in unique clusters may have different uses for A/C (acupuncture and chiropractic) services and/or differential outcomes associated with such care.

Phase 2 will conduct a survey of CMP patients from KPNW (Kaiser Permanente Northwest region) to establish a broad sample of patients and their use of out-of-plan CAM services.

Phase 3 will collect qualitative data (focus groups and individual interviews) from KP members, KP providers, and acupuncturists and chiropractors from the community to examine KP providers' decision to recommend A/C services, A/C services delivered to KP patients, and patients' decisions to pursue and retain CAM care. A secondary purpose is to have KP members with CMP review planned assessment instruments to improve understandability of the instruments. They will provide feedback on: relevancy, any notable omissions of domains important in patients' decision to use CAM services for pain treatment. They will also provide insight to broader health and quality of life outcomes associated with such CAM treatments.

Phase 4 is a prospective cohort study to evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Pain severity & interference [ Time Frame: Baseline, 1-, 3-, 6-, 12-months ] [ Designated as safety issue: No ]
    Two subscales -- the 4-item pain severity and the 7-item pain interference subscales -- from the short form of the Brief Pain Inventory (BPI-SF) will be used to assess pain and related disability.


Estimated Enrollment: 1320
Study Start Date: December 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Substantial recent research examines the efficacy and biological basis of many types of complementary and alternative (CAM) therapies. However, "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced and urging high prioritization for research that includes clinical outcomes, cost-effectiveness, and the decision-making process for patients and providers. There is, therefore, heightened need for enriched understanding—particularly given CAM's growing popularity, which fortunately offers stores of new data for research. Recent studies suggests that Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain—despite their high costs, potential adverse effects, and modest efficacy—suggests the need to evaluate the outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community.

This study responds to the NCCAM program announcement PAR-08-045, "Outcomes, Cost-Effectiveness and the Decision Making Process to Use CAM."

Because this project consists of four discrete sets of project activities (that largely follow one another chronologically), the investigators plan to submit separate IRQs to cover each set of project activities as follows:

(Phase1) Retrospective study using information from the EMR to identify unique clusters of patients with CMP, their trajectories of care within the health plan, and to examine how those in unique clusters may have differing propensities for the use of A/C services and/or differential outcomes associated with such care. The IRQ for this study has been submitted (Phase 2) The administration of an out-of-plan CAM survey to determine from a broad sample of KP members their use of such services.

(Phase 3) The collection of qualitative data (focus groups and individual interviews) from KP members, KP providers, and acupuncturists and chiropractors from the community to examine KP providers decision to recommend A/C services, A/C services delivered to KP patients, and patients' decisions to pursue and retain CAM care. A secondary purpose is to have KP members with CMP review planned assessment instruments for phase 4 of the study to provide feedback on: relevancy, any notable omissions of domains important in patients' decision to use CAM services for pain treatment and broader health and quality of life outcomes associated with such CAM treatments, as well as to review understandability of the assessment instruments.

(Phase 4) A prospective cohort study to evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic musculoskeletal pain (CMP)

Criteria

Inclusion Criteria:

  • KPNW health plan members
  • 18 or older
  • Evidence of CMP

Exclusion Criteria:

  • Malignant cancer diagnosis
  • Hospice or other end-of-life palliative care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345409

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
University of Arizona
Oregon Health and Science University
Investigators
Principal Investigator: Lynn DeBar, PhD Kaiser Permanente
  More Information

No publications provided by Kaiser Permanente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01345409     History of Changes
Other Study ID Numbers: 1 R01 AT 005896-01
Study First Received: April 28, 2011
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Musculoskeletal pain
Chronic pain
Acupuncture
Chiropractic

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014