Pain, PostoperativeNCT04044716

Nurse Initiated Acupressure for Pain Management

A study testing Auricular acupressure in people with Pain, Postoperative and Pain, Acute, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain, Postoperative, Pain, Acute
What is being tested?: Auricular acupressure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 31 Dec 2019to 4 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults 18-80 admitted for knee or hip arthroplasty
Pre-surgery morphine equivalent < 50
American Society of Anaesthesiologists (ASA) score < 3

Who cannot join

Participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Davie Medical Center
Bermuda Run, North Carolina, 27006

Other trials in United States

About this study

Official title: Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and Hip Arthroplasty Patients

The purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management.

Read the detailed description

Postoperative pain management has become an area of concern over the last decade due to the opioid epidemic and concerns related to their use as the primary pain management strategy. Joint Commission requires that hospitals have additional pain non-pharmacologic pain management tools at their disposal to an effort decrease the reliance on opioids. Acupuncture and acupressure have been used for centuries in the management of a variety of disorders including pain. Unlike acupuncture, acupressure can be easily applied with limited training and is within the scope of practice for nurses, according to the North Carolina Board of Nursing. Thus evidence based non-pharmacologic strategies that can be deployed by nursing are of benefit to hospital organizations.

Conditions: Pain, Postoperative, Pain, Acute
Being tested: Auricular acupressure, Standard of care pain management
Keywords: auricular acupressure, anesthesia
Medical subject headings: Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Auricular acupressureDevice
Also called acupressure
Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist.
Standard of care pain managementOther
The participant post-operative pain will be managed following the standard protocol by the treating physician.

Study groups in NCT04044716
Study group	Role	What they receive
Auricular acupressure Group	Experimental	The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively. Receives: Device: Auricular acupressure; Other: Standard of care pain management
Standard of care Group	Active comparator	Participants in this group will receive standard of care pain management by the treating physician. Receives: Other: Standard of care pain management
Nurse Interventionists	No intervention	Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4.
Measured: Up to Post-operatively day 4, at rising approximately 6 am
Visual Analogue Pain Scale
Average "pain before bed" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).Pain score averaged across post-op days 0 - 4.
Measured: Up to Post-operatively day 4, at the end of the day approximately 10 pm
Medication Use - Outpatient Opioids
Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively
Measured: Up to post-operatively day 4
Medication Use - Inpatient Opioids
Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)
Measured: Up to post-operatively day 4
Medication Use - Total Other Analgesics
Amount of of other analgesics other than aspirin and not part of anesthesia record from immediate post-operative period to day 4 post-op in reported milligrams.
Measured: Up to post-operatively day 4

Secondary outcomes (14)

Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: Baseline
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 1, at rising
Visual Analogue Pain Scale
Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.
Measured: post-operatively day 2, at rising
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 3, at rising
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 4, at rising
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 1, at the end of the day
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 2, at the end of the day
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 3, at the end of the day
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Measured: post-operatively day 4, at the end of the day
Mean Number of Pellets Retained
Mean number of pellets retained on post-operative day 4. This Outcome Measure was pre-specified to be assessed for the "Auricular Acupressure Group" Arm only.
Measured: Up to post-operatively day 4
Number of Participants Who Responded They Were Satisfied With Pain Management
Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes. Force choice: very satisfied, satisfied, somewhat satisfied, somewhat dissatisfied, dissatisfied, very dissatisfied. Any degree of satisfaction compared to any degree of dissatisfaction. Satisfied included responses very satisfied to somewhat satisfied
Measured: post-operatively day 4
Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future."
Participants were asked if they "would consider using auricular acupressure in the future for pain if recommended by a nurse or physician?" Possible answers are "no, would not use again", "maybe", or "Yes, would definitely consider using in the future."
Measured: post-operatively day 4
Nurse Time to Deploy Pellets
Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction.
Measured: post-operatively day 5
Number of Nurse Concerns Reported
Review nurse reports in encounters. Count number of concerns pooled across all participants in encounters with disruption of workflow due to care unit or patient barriers documented while participant was in hospital. Concerns included workflow and patient barriers. This outcome applies to nurse interventionists arm only.
Measured: post-operatively day 0 and 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 20194 Oct 2021

First posted5 Aug 2019
Study start31 Dec 2019
Primary completion4 Oct 2021
Study completion4 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04044716
Sponsor's protocol ID: IRB00057513
Status last verified: Dec 2022
First submitted: 1 Aug 2019
Last updated: 7 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and Hip Arthroplasty Patients
ClinicalTrials.gov ID: NCT04044716
Acronym / sponsor ID: IRB00057513
Conditions: Pain, Postoperative, Pain, Acute
Keywords: auricular acupressure, anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 31 Dec 2019 (actual)
Primary completion: 4 Oct 2021 (actual)
Study completion: 4 Oct 2021 (actual)
First posted: 5 Aug 2019 (actual)
Results: Posted 7 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group

Arm	Type	Receives
Auricular acupressure Group	Experimental	Device: Auricular acupressure, Other: Standard of care pain managementThe Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.
Standard of care Group	Active comparator	Other: Standard of care pain managementParticipants in this group will receive standard of care pain management by the treating physician.
Nurse Interventionists	No intervention	–Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults 18-80 admitted for knee or hip arthroplasty
Pre-surgery morphine equivalent < 50
American Society of Anaesthesiologists (ASA) score < 3

Key exclusion criteria (1 listed)

Participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Auricular acupressureAlso: acupressureTrained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist.	Device	Auricular acupressure Group
Standard of care pain managementThe participant post-operative pain will be managed following the standard protocol by the treating physician.	Other	Auricular acupressure Group, Standard of care Group

Primary outcome

Visual Analogue Pain Scale
Time frame: Up to Post-operatively day 4, at rising approximately 6 am
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4.
Visual Analogue Pain Scale
Time frame: Up to Post-operatively day 4, at the end of the day approximately 10 pm
Average "pain before bed" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).Pain score averaged across post-op days 0 - 4.
Medication Use - Outpatient Opioids
Time frame: Up to post-operatively day 4
Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively
Medication Use - Inpatient Opioids
Time frame: Up to post-operatively day 4
Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)
Medication Use - Total Other Analgesics
Time frame: Up to post-operatively day 4
Amount of of other analgesics other than aspirin and not part of anesthesia record from immediate post-operative period to day 4 post-op in reported milligrams.

14 secondary outcomes

Visual Analogue Pain Scale
Time frame: Baseline
Visual Analogue Pain Scale
Time frame: post-operatively day 1, at rising
Visual Analogue Pain Scale
Time frame: post-operatively day 2, at rising
Visual Analogue Pain Scale
Time frame: post-operatively day 3, at rising
Visual Analogue Pain Scale
Time frame: post-operatively day 4, at rising
Visual Analogue Pain Scale
Time frame: post-operatively day 1, at the end of the day
Visual Analogue Pain Scale
Time frame: post-operatively day 2, at the end of the day
Visual Analogue Pain Scale
Time frame: post-operatively day 3, at the end of the day
Visual Analogue Pain Scale
Time frame: post-operatively day 4, at the end of the day
Mean Number of Pellets Retained
Time frame: Up to post-operatively day 4
Number of Participants Who Responded They Were Satisfied With Pain Management
Time frame: post-operatively day 4
Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future."
Time frame: post-operatively day 4
Nurse Time to Deploy Pellets
Time frame: post-operatively day 5
Number of Nurse Concerns Reported
Time frame: post-operatively day 0 and 1

Results and safety

Results posted to the registry on 7 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Auricular Acupressure Group	30	27
Standard of Care Group	30	27
Nurse Interventionists	5	5

Primary outcome: Visual Analogue Pain Scale

Time frame: Up to Post-operatively day 4, at rising approximately 6 am. Mean (Standard Deviation). Unit: units on a scale

Measure	Auricular Acupressure Group n = 26	Standard of Care Group n = 25
Value	3.03 (2.04)	4.37 (2.18)

Auricular Acupressure Group vs Standard of Care Group: p = .048, ANCOVA

Population analysed: 1 in Treatment and 2 in Standard of Care (SOC) group with incomplete missing data.

Primary outcome: Visual Analogue Pain Scale

Time frame: Up to Post-operatively day 4, at the end of the day approximately 10 pm. Mean (Standard Deviation). Unit: units on a scale

Measure	Auricular Acupressure Group n = 24	Standard of Care Group n = 24
Value	5.27 (2.51)	6.11 (2.21)

Auricular Acupressure Group vs Standard of Care Group: p = 0.29, ANCOVA

Population analysed: 3 in Treatment group and 3 in Standard of Care (SOC) group with missing data.

Primary outcome: Medication Use - Outpatient Opioids

Time frame: Up to post-operatively day 4. Mean (Standard Deviation). Unit: morphine milligram equivalents

Measure	Auricular Acupressure Group n = 26	Standard of Care Group n = 26
Value	74.2 (58.9)	88.6 (73.1)

Auricular Acupressure Group vs Standard of Care Group: p = 0.64, ANCOVA

Population analysed: 1 in Treatment group and 1 in Standard of Care (SOC) group with missing data.

Primary outcome: Medication Use - Inpatient Opioids

Time frame: Up to post-operatively day 4. Mean (Standard Deviation). Unit: MME

Measure	Auricular Acupressure Group n = 30	Standard of Care Group n = 30
Value	37.8 (28.3)	35.8 (28.6)

Auricular Acupressure Group vs Standard of Care Group: p = 0.86, ANCOVA

Population analysed: Data obtained from hospital medication administration record on all participants.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected from post-operative day 0 - post-operative day 5. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Auricular Acupressure Group	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
Standard of Care Group	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Carolyn S Huffman, WHNP, PhD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupressure in people with Pain, Postoperative and Pain, Acute, run by Wake Forest University Health Sciences 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?

The sponsor lists 3 inclusion and 1 exclusion criteria. 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 7 Dec 2022. 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?

Yes. Results are posted in the registry (first posted 7 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Visual Analogue Pain Scale (time frame: Up to Post-operatively day 4, at rising approximately 6 am). The study lists 5 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 NCT04044716.

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 7 Dec 2022.