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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain

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.

• Study Type: Observational
• Enrollment (Actual): 1242

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic musculoskeletal pain (CMP)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity & interference	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.	Baseline, 1-, 3-, 6-months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Oregon Health and Science University; University of Arizona
• Investigators: Principal Investigator: Lynn DeBar, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• Penney LS, Ritenbaugh C, DeBar LL, Elder C, Deyo RA. Provider and patient perspectives on opioids and alternative treatments for managing chronic pain: a qualitative study. BMC Fam Pract. 2017 Mar 24;17(1):164. doi: 10.1186/s12875-016-0566-0.
• DeBar LL, Elder C, Ritenbaugh C, Aickin M, Deyo R, Meenan R, Dickerson J, Webster JA, Jo Yarborough B. Acupuncture and chiropractic care for chronic pain in an integrated health plan: a mixed methods study. BMC Complement Altern Med. 2011 Nov 25;11:118. doi: 10.1186/1472-6882-11-118.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Acupuncture; Chronic pain; Musculoskeletal pain; Chiropractic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1R01AT005896-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No