Auricular Acupressure in Prehabilitation

NCT06516198 | Recruiting

• 1 other identifier: IRB24-0888
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Thoracic; Prehabilitation; Lung Surgery; Wedge Resection; Segmentectomy; Lobectomy; Pneumonectomy; Status

Keywords

accupressure; vaccaria seeds

Outcome Measures

Primary Outcomes (1)

• Number of patients enrolled

  The patient will complete a form after each seed pressing confirming the pressing and the time.

  2 weeks

Secondary Outcomes (1)

• Ease of participation in the study.

  End of Study (Week 4)

Other Outcomes (2)

• Accuracy of seed placement by a non-professional care partner.

  Weekly until Week 4

• The change of the intervention prehabilitation results

  End of Study (Week 4)

Study Arms (2)

Experimental Group

EXPERIMENTAL

A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group. o Intervention group seed points: 1. Shen Men (anxiety, depression, stress, pain) 2. Point 0 (homeostasis, energy, mood) 3. Endocrine (hormonal homeostasis) 4. Subcortex (insomnia, anxiety, pain, inflammation) 5. Autonomic (autonomic balance, pain)

Other: Auricular Acupressure

Control Group

SHAM COMPARATOR

A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group. o Control group sham seed points: 1. Inside edge, center of tragus 2. Helix midway between apex and tubercle 3. Helix 1 cm anterior to apex 4. 5 mm anterior to Shen Men 5. Covered, 5 mm anterior and superior to endocrine For the sham intervention (Sham Type II, same intervention with seeding and intermittent pressing) the seeds are placed at nonacupressure points for the control group.

Other: Auricular Acupressure

Interventions

Auricular Acupressure OTHER

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 the remaining 2 seeds. Pressing consists of applying pressure, gradually increasing the pressure until the patient expresses discomfort, and maintaining that pressure until 2 minutes have passed. After pressing has been performed for each seed, the seeds are removed in clinic prior to clinic discharge.

Control Group; Experimental Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Lucia Madariaga, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Lucia Madariaga, MD

CONTACT

7737022500; mlmadariaga@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group. For the sham intervention (Sham Type II, same intervention with seeding and intermittent pressing) the seeds are placed at nonacupressure points for the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 23, 2024
• Study Start: July 21, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)