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Recruiting NCT06516198

Auricular Acupressure in Prehabilitation

No phase Interventional Frailty Thoracic Prehabilitation Lung Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricular Acupressure.
Who it may be relevant to
Registry conditions: Frailty, Thoracic, Prehabilitation, Lung Surgery. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study of the Utility of Auricular Acupressure in Enhancing Prehabilitation Benefits in Candidates for Thoracic Surgery.

Overview

Complementary medicine is recognized for its ability to enhance appetite, increase energy, reduce anxiety, decrease pain, and improve sleep, among many other benefits. Acupuncture is among the most frequent types of complementary medicine practiced in the US, and Medicare currently includes back pain as a reimbursable indication for this therapy. Acupuncture-related therapies may enhance efforts at prehabilitation in candidates for major lung resection.

Detailed description

The plan is to use a small number of points for auricular acupressure that are selected to improve overall health, both physical and mental. Auricular acupuncture for management of pain using 5 points, informally referred to as "battlefield acupuncture" has demonstrated significant improvement in acute and chronic pain management. Auricular acupressure using a similarly small number of points has demonstrated improvement in chemotherapy-related disturbed sleep, fatigue, and appetite, postpartum depression and fatigue, and chemotherapy related fatigue and depression. It appears that auricular acupressure may be suitable for enhancing prehabilitation interventions for preoperative patients.

Patients will be selected from among individuals being considered for major lung surgery (wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy; open or minimally invasive) who are expected to pursue a period of prehabilitation of 2 or more weeks prior to surgery.

Interventions

  • Other Auricular Acupressure
    Seeds will be placed during the clinic visit by the acupuncturist or the research associate according to the group the patient was assigned to. The care partner will observe the placement. A photograph of the seed placement will be taken and given to the care partner and to the patient after the relevant points are labeled by number or letter. The method of pressing is demonstrated for 1 one of the seeds, the care partner practices pressing on 2 other seeds, and the patient practices pressing on

Primary outcome measures

  • Number of patients enrolled [Time frame: 2 weeks]
Secondary outcome measures (1)
  • Ease of participation in the study. [Time frame: End of Study (Week 4)]

Eligibility criteria

Inclusion criteria

  • Being considered for major lung surgery
  • Surgery is not scheduled for at least 2 weeks
  • Age ≥ 50 years
  • Able to understand English at a 4th grade level
  • No known contraindications to prehabilitation (strength, endurance, balance exercises)
  • Able to provide informed consent for participation
  • Has an adult care partner who will be available and capable of placing seeds
  • Has access to smart phone for communication and image sharing
  • Underwent frailty screening (given any score)
  • Able to perform spirometry testing in clinic

Exclusion criteria

  • Allergy to Vaccaria seeds
  • Medical condition affecting either ear preventing use of auricular acupressure such as eczema, frostbite, sunburn

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Chicago — Chicago

Publications

  • Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19. PMID 24138333
  • Ferguson MK, Watson S, Johnson E, Vigneswaran WT. Predicted postoperative lung function is associated with all-cause long-term mortality after major lung resection for cancer. Eur J Cardiothorac Surg. 2014 Apr;45(4):660-4. doi: 10.1093/ejcts/ezt462. Epub 2013 Sep 19. PMID 24052607

Identifiers

NCT: NCT06516198 · IRB24-0888

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗