Effect of Complementary and Alternative Medicine on Pain Among Inpatients

January 9, 2017 updated by: Allina Health System

The proposed study has 3 aims: 1) quantitatively describe a model for delivering complementary and alternative medicine (CAM) therapies to understand the selection of patients and CAM therapies used for pain management, 2) examine the effects of selected CAM therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies on duration of pain change.

Positive results from this study will assist hospitals in the integration of usual care and CAM therapy for pain reduction. Findings may also drive future research on the cost effectiveness of these therapies for pain management, as well as the impact on patient outcomes such as length of stay and use of narcotics.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4422

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Abbott Northwestern Hospital Inpatients

Description

Aims 1 and 2 Inclusion Criteria:

  • Admission to Abbott Northwestern Hospital
  • Consent to release of electronic health record for research purposes
  • 18 years of age or older
  • Length of stay greater than 24 hours

Aims 1 and 2 Exclusion Criteria:

  • None

Aim 3 Inclusion Criteria:

  • Admission to Abbott Northwestern Hospital
  • Length of stay greater than 24 hours
  • 18 years of age or older
  • Consent to release of electronic health record for research purposes
  • Received CAM therapy in current hospitalization
  • Pain level of 1 or greater at the pre-treatment assessment by practitioner
  • English-speaking
  • Integrative medicine therapy ended between 9:00 am and 4:00 pm

Aim 3 Exclusion Criteria:

  • Refuses consent
  • Unable to provide consent due to competency concerns
  • Has declined study participation 3 times during current hospitalization
  • Has hard declined during current hospitalization
  • Has been approached 6 times during current hospitalization
  • Has been approached to consent earlier that day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Model of delivering CAM therapies
Time Frame: Up to 4 years
Quantitatively describe a model for delivering CAM therapies to understand selection of patients and CAM therapies used for pain management.
Up to 4 years
Effects of selected CAM therapies on immediate change in pain
Time Frame: CAM Visit (30-45 minutes)
We will examine the effectiveness of CAM therapies on self-reported (11 point scale) pain measured just before and immediately after service delivery.
CAM Visit (30-45 minutes)
Effects of selected CAM therapies on duration of pain change.
Time Frame: 5 hours
We will examine the effectiveness of CAM therapies on repeated measures of self-reported pain over several hours after therapy to assess the distribution and decay of the pain change effect.
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jeffery Dusek, PhD, Allina Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AT006518-01
  • R01AT006518-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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