NCT02888340

Brief Summary

The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory (and potential cycle) of medication misuse by providing an alternative at a critical point of contact within the healthcare system, potentially disrupting the pathway from ED visit to opioid usage after discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

March 25, 2016

Last Update Submit

May 3, 2018

Conditions

Keywords

AcupunctureEmergency DepartmentPain

Outcome Measures

Primary Outcomes (1)

  • Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department

    Assess feasibility of triaging and treating patients presenting to the emergency department with protocol defining criteria and then having that patient participate in a randomized controlled trial comparing acupuncture to usual care. This will be assessed by the number of patients approached compared to the number of patients consented and by the number of patients able to receive acupuncture while in the Emergency Department.

    At study completion, one year

Secondary Outcomes (2)

  • Pain Reduction

    During day 1 of study participation

  • Opioid use

    At study completion, one year

Study Arms (2)

Acupuncture

EXPERIMENTAL

One session of acupuncture prior to receiving pain medications after arriving to the emergency department with pain as a symptom.

Other: Acupuncture

Usual Care

NO INTERVENTION

Usual care for pain, without intervention, after arriving to the emergency department with pain as a symptom.

Interventions

Acupuncture involves inserting thin, sterile needles into the skin. The needles do not go into the skin very far. Number of acupuncture sessions: one.

Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Ability to communicate in English
  • Non-critical status as determined at triage and / or by a clinic provider
  • Presentation to the emergency department with acute musculoskeletal, back, pelvic, non-cardiac chest, abdominal, and headache pain (≥ 4 on the numerical rating scale), due to non-penetrating injury. Acute pain is defined by pain occurring within 72 hours of ED presentation (this can be an acute flare-up of a chronic pain condition).

You may not qualify if:

  • Current pregnancy
  • Need for emergent treatment as determined at triage and / or by a clinic provider (Level 1 or 2 on triage rating scale)
  • Bone fracture
  • Joint dislocation
  • Fever exceeding 100° F
  • Opioid medication taken orally within 4 hours (determined per patient report)
  • Current use of a pharmaceutical analgesic patch
  • Presenting with a chief complaint of a psychological / psychiatric concern
  • Presenting with a migraine
  • Having a unique treatment plan (UTP) on file with Abbott Northwestern Hospital
  • Patient arriving via ambulance due to skipping triage
  • Currently participating in this study due to previous ED admission
  • Medical provider decision / clinical judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (1)

  • Reinstein AS, Erickson LO, Griffin KH, Rivard RL, Kapsner CE, Finch MD, Dusek JA. Acceptability, Adaptation, and Clinical Outcomes of Acupuncture Provided in the Emergency Department: A Retrospective Pilot Study. Pain Med. 2017 Jan 30;18(1):169-178. doi: 10.1093/pm/pnv114.

    PMID: 26917627BACKGROUND

MeSH Terms

Conditions

PainEmergencies

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2016

First Posted

September 5, 2016

Study Start

April 1, 2016

Primary Completion

July 6, 2017

Study Completion

July 6, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations