NCT04044716

Nurse Initiated Acupressure for Pain Management

Completed NA Results posted Last updated 7 December 2022

What this trial tests

NA trial testing Auricular acupressure in Pain, Postoperative in 65 participants. Completed in 4 October 2021.

Timeline

31 December 2019

Primary endpoint
4 October 2021

4 October 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	65
Start date	31 December 2019
Primary completion	4 October 2021
Estimated completion	4 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Auricular acupressure
• Standard of care pain management

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Pain, Acute — all drugs for Pain, Acute →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 80, any sex, with Pain, Postoperative or Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analogue Pain Scale Primary · 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.

Group	Value	95% CI
Auricular Acupressure Group	3.03	± 2.04
Standard of Care Group	4.37	± 2.18

Visual Analogue Pain Scale Primary · 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.

Group	Value	95% CI
Auricular Acupressure Group	5.27	± 2.51
Standard of Care Group	6.11	± 2.21

Medication Use - Outpatient Opioids Primary · Up to post-operatively day 4

Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively

Group	Value	95% CI
Auricular Acupressure Group	74.2	± 58.9
Standard of Care Group	88.6	± 73.1

Medication Use - Inpatient Opioids Primary · Up to post-operatively day 4

Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)

Group	Value	95% CI
Auricular Acupressure Group	37.8	± 28.3
Standard of Care Group	35.8	± 28.6

Medication Use - Total Other Analgesics Primary · 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.

Group	Value	95% CI
Auricular Acupressure Group	13643	± 4615
Standard of Care Group	13766	± 3395

Visual Analogue Pain Scale Secondary · Baseline

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Group	Value	95% CI
Auricular Acupressure Group	2.30	± 2.28
Standard of Care Group	2.84	± 2.69

Visual Analogue Pain Scale Secondary · post-operatively day 1, at rising

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Group	Value	95% CI
Auricular Acupressure Group	3.05	± 2.36
Standard of Care Group	3.90	± 2.52

Visual Analogue Pain Scale Secondary · post-operatively day 2, at rising

Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.

Group	Value	95% CI
Auricular Acupressure Group	3.76	± 2.79
Standard of Care Group	5.01	± 2.70

Visual Analogue Pain Scale Secondary · post-operatively day 3, at rising

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Group	Value	95% CI
Auricular Acupressure Group	2.60	± 2.02
Standard of Care Group	4.46	± 2.42

Visual Analogue Pain Scale Secondary · post-operatively day 4, at rising

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Group	Value	95% CI
Auricular Acupressure Group	2.81	± 2.13
Standard of Care Group	4.25	± 2.37

Visual Analogue Pain Scale Secondary · post-operatively day 1, at the end of the day

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Group	Value	95% CI
Auricular Acupressure Group	5.64	± 3.11
Standard of Care Group	6.46	± 2.54

Visual Analogue Pain Scale Secondary · post-operatively day 2, at the end of the day

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Group	Value	95% CI
Auricular Acupressure Group	5.79	± 2.73
Standard of Care Group	6.48	± 2.41

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events collected from post-operative day 0 - post-operative day 5. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Auricular Acupressure Group

Serious: 0/30 (0%)

Deaths: 0/30

Standard of Care Group

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (1 terms — click to expand)

Reaction	System	Auricular Acupressure Group	Standard of Care Group
Irritation at auricular acupressure site	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04044716 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nurse initiated auricular acupressure for post-operative pain control in patients undergoing TKA or THA: A randomized controlled trial.
   Huffman C, Olson J, Evans JK, Brady T, et al · · 2024 · cited 3× · PMID 37429783 · DOI 10.1016/j.ijotn.2023.101035