NCT02190240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,422

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

July 8, 2014

Last Update Submit

January 9, 2017

Conditions

Pain

Keywords

Complementary and Alternative MedicineIntegrative MedicinePain Management

Outcome Measures

Primary Outcomes (3)

  • Model of delivering CAM therapies

    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

    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.

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Abbott Northwestern Hospital Inpatients

You may qualify if:

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

You may not qualify if:

  • None
  • Admission to Abbott Northwestern Hospital
  • Length of stay greater than 24 hours
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (1)

  • Dusek JA, Rivard RL, Griffin KH, Finch MD. Significant Pain Reduction in Hospitalized Patients Receiving Integrative Medicine Interventions by Clinical Population and Accounting for Pain Medication. J Altern Complement Med. 2021 Mar;27(S1):S28-S36. doi: 10.1089/acm.2021.0051.

    PMID: 33788611DERIVED

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Jeffery Dusek, PhD

    Allina Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 15, 2014

Study Start

January 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)