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Chronic PainReliefNCT01345409

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

An observational study of Chronic Pain, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
How many people
1,242 participants
Where
1 siteUnited States
Study dates
Dec 2010to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with chronic musculoskeletal pain (CMP)

Who may be able to join

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

Who cannot join

  • Malignant cancer diagnosis
  • Hospice or other end-of-life palliative care

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227

Other trials in United States

About this study

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).

Read more

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.

Read the 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.

Conditions
Chronic Pain
Keywords
Musculoskeletal pain, Chronic pain, Acupuncture, Chiropractic
Medical subject headings
Chronic Pain, Musculoskeletal Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1-, 3-, 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345409
Sponsor's protocol ID
1R01AT005896-01
Acronym
Relief
Status last verified
Dec 2016
First submitted
28 Apr 2011
Last updated
23 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 28403822
  • 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.

    PubMed 22118061

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain severity & interference (time frame: Baseline, 1-, 3-, 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01345409, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.

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