PainNCT02190240
Effect of Complementary and Alternative Medicine on Pain Among Inpatients
An observational study of Pain, run by Allina Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 4,422 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2015
- 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: Abbott Northwestern Hospital Inpatients
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
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.
- Conditions
- Pain
- Keywords
- Complementary and Alternative Medicine, Integrative Medicine, Pain Management
- Medical subject headings
- Pain, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJan 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Enrolment
- 4,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Jeffery Dusek, PhD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190240
- Sponsor's protocol ID
- AT006518-01
- Other IDs
- R01AT006518-01
- Status last verified
- Jan 2017
- First submitted
- 8 Jul 2014
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33788611
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Complementary and Alternative Medicine on Pain Among Inpatients
- ClinicalTrials.gov ID
- NCT02190240
- Acronym / sponsor ID
- AT006518-01
- Conditions
- Pain
- Keywords
- Complementary and Alternative Medicine, Integrative Medicine, Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,422 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Abbott Northwestern Hospital Inpatients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 33788611Dusek 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Dusek, PhD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Allina Health System 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?
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 10 Jan 2017. 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?
Model of delivering CAM therapies (time frame: Up to 4 years). The study lists 3 primary outcomes in all. 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 NCT02190240, 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 10 Jan 2017.