NCT01621139

Brief Summary

The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

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

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2.5 years

First QC Date

March 29, 2012

Last Update Submit

November 12, 2013

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

  • RASS (Richmond Agitation Sedation Scale)

    baseline to six months

Secondary Outcomes (2)

  • ABPS (Aberdeen Back Pain Scale)

    baseline to six months

  • Pain Scale

    baseline to six months

Study Arms (2)

Real acupuncture

EXPERIMENTAL

Real acupuncture group

Procedure: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Sham acupuncture group

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group

Real acupunctureSham acupuncture

Eligibility Criteria

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

You may qualify if:

  • Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included.

You may not qualify if:

  • Children \< 18 years of age
  • Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication)
  • Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP \< 90 or \> 180 mm Hg for longer than 2 continuous hours
  • Patients who are pregnant or pre-menopausal
  • Patients with expected survival less than 6 3 months
  • Major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupuncture treatment areas.
  • Patients with a pacemaker or other implanted electronic device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 29, 2012

First Posted

June 18, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

US(1)