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Chronic Low Back PainCERCNCT03162952

RAND Center of Excellence for the Study of Appropriateness of Care in CAM

An observational study of Chronic Low Back Pain and Chronic Neck Pain, run by RAND 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

The RAND approach to appropriateness makes it feasible to take the best of what is known from research and apply it-using the expertise of experienced clinicians-over the wide range of patients and presentations seen in real-world clinical practice. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chronic Low Back Pain, Chronic Neck Pain
How many people
2,025 participants
Where
1 siteUnited States
Study dates
30 Sep 2011to 31 Dec 2018
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chiropractic physicians Chiropractic patients

Who may be able to join

  • Current chiropractic patient over 21 years with chronic low back pain and chronic cervical pain.
  • They must have had the pain for 3 months.

Who cannot join

  • Under 21, non-specific chronic low back pain or cervical pain, personal injury case able to access the project on line.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • RAND Corporation

    Santa Monica, California, 90407

Other trials in United States

About this study

The RAND approach to appropriateness makes it feasible to take the best of what is known from research and apply it-using the expertise of experienced clinicians-over the wide range of patients and presentations seen in real-world clinical practice. The major limitation of the RAND approach, however, is that it still utilizes a limited definition of appropriateness; one that relies heavily on safety, efficacy and effectiveness. Until now the RAND method has not included patient preferences or resource utilization effectiveness. These are both serious absences. In the past decade we have seen an evolution in outcome measures from clinician based objective measures to patient-centered and subjective measures. The development of Patient Based Outcome Assessments (PBOA); Patient Reported Outcomes Measurement Information System (PROMIS) and the recent establishment of Patient-Centered Outcomes Research Institute (PCORI) all contest to the growing importance of the patient's perspective in determining outcomes and therefore also appropriateness. In the Center, we propose to advance appropriateness methods by adding three additional dimensions to the RAND appropriateness methods: patient outcomes, patient preferences and cost

Read the detailed description

The primary objective of this Center of Excellence is:

Develop and refine methods for the study of the appropriateness of care in CAM.

This Center of Excellence will have four Projects.

  • Project 1: Clinician Based Appropriateness
  • Project 2: Outcomes Based Appropriateness
  • Project 3: Patient Preferences Appropriateness
  • Project 4 : Resource Utilization Based Appropriateness

Because much of CAM faces the challenge of limited evidence], and because these methods are well-established, we will have as our core project

Project 1: Clinician-Based Appropriateness the application of the RAND approach to the determination of appropriate care for Manipulation/Mobilization (M/M) for chronic .low back pain (CLBP) and chronic cervical pain (CCP). This approach uses a mixed (CAM and non-CAM) panel of expert clinicians to interpret syntheses of all available data on safety, efficacy and effectiveness and clinical experience to apply these data to the question of care appropriateness for low back and cervical M/M. This approach has been applied successfully to M/M for low back pain and a literature review and expert panel was previously done for M/M for cervical manipulation.

The main objectives of the core project (Project 1) are to develop a set of ratings of the appropriateness of M/M for chronic low back and chronic neck pain across various patient presentations, to be used in the determination of the prevalence of appropriate and inappropriate care in a national sample of these patients, and to provide feedback to the research community regarding the patient presentations where substantial uncertainty remains as to the appropriateness of M/M. We will also, however, in the Resource Utilization project examine M/M in relationship to other forms of a non-invasive therapy for cervical pain to get comparative ratings of appropriateness.

Objectives of the Other Center Projects. The other projects in the Center each add to the RAND-based method in different ways by exploring the broader dimensions of appropriateness which may be applicable for CAM as well as health care in general. Project 2 (Outcomes Based Appropriateness) will examine the patient-assessed outcomes which, in part, contribute to the determination of appropriateness made by patients. Its objectives include developing CAM-sensitive PROMIS measures for patients using manipulation/mobilization for CLBP and CCP and to analyze data collected from a national study of chiropractic patients with CLBP and that can be used to evaluate appropriateness of their care from the patient's perspective. Given the prevalence of patient self-referral in CAM and the health system-wide focus on patient-centered care, Project 3 (Patient Preference Appropriateness) will examine how patient preferences affect what is considered to be appropriate care. Objectives here include understanding how CLBP and CCP patients decide to use M/M and determining what they believe is appropriate care. Finally, given the high proportion of out-of-pocket costs in CAM and the dramatic rise of healthcare costs in general, Project 4 (Resource Utilization Based Appropriateness) will examine how cost affects both which care is most appropriate and the appropriate course of care once implemented. Objectives here include providing data on the relative cost-effectiveness of care options for CLBP and CCP to the Appropriateness Panel (Project 1) to see if cost data changes their ratings, and analyzing data from our national sample to begin to understand the characteristics of an appropriate course of care once M/M is chosen.

Keywords
Chronic pain
Medical subject headings
Chronic Pain

What is being measured

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

  1. Project 1 Clinical Appropriateness

    Measuring appropriateness rate of manipulation for chronic back pain

    Measured: 4 years

Timeline

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

  1. First posted22 May 2017
  2. Study start30 Sep 2011
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

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
Other
Enrolment
2,025 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03162952
Sponsor's protocol ID
1U19AT007912-10 REVISED
Other IDs
1U19AT007912
Acronym
CERC
Status last verified
Apr 2019
First submitted
16 Feb 2017
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Herman PM, Edgington SE, Sorbero ME, Hurwitz EL, Goertz CM, Coulter ID. Visit Frequency and Outcomes for Patients Using Ongoing Chiropractic Care for Chronic Low-Back and Neck Pain: An Observational Longitudinal Study. Pain Physician. 2021 Jan;24(1):E61-E74.

    PubMed 33400439

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Low Back Pain and Chronic Neck Pain, run by RAND 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 2 inclusion and 1 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 16 Apr 2019. 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?

Project 1 Clinical Appropriateness (time frame: 4 years). 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 NCT03162952, which also lists 1 linked publication.

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 16 Apr 2019.

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