Effect of Complementary and Alternative Medicine on Pain Among Inpatients

Pain Clinical Trial

Official title:

Effect of Complementary and Alternative Medicine on Pain Among Inpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190240
• Other study ID #: AT006518-01
• Secondary ID: R01AT006518-01
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: January 9, 2017
• Start date: January 2012
• Est. completion date: May 2015

Study information

• Verified date: January 2017
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4422
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Allina Health System	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Primary	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	No