Auricular Acupressure in Prehabilitation

NCT ID: NCT06516198

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2027-06-20

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

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)

Group Type: EXPERIMENTAL

Auricular Acupressure

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Auricular Acupressure

Intervention Type: 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.

Interventions

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 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Lucia Madariaga, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maria Lucia Madariaga, MD

Role: CONTACT

mlmadariaga@bsd.uchicago.edu

7737022500

Facility Contacts

Maria Lucia Madariaga

Role: primary

mlmadariaga@bsd.uchicago.edu

773-702-2500

References

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.

Reference Type: RESULT

PMID: 24138333 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24052607 (View on PubMed)

Other Identifiers

IRB24-0888

Identifier Type: -

Identifier Source: org_study_id