Clinical trial NCT06516198: Auricular Acupressure in Prehabilitation
Official title: A Pilot Study of the Utility of Auricular Acupressure in Enhancing Prehabilitation Benefits in Candidates for Thoracic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Thoracic
Prehabilitation
Lung Surgery
Wedge Resection
Segmentectomy
Lobectomy
Pneumonectomy; Status
Keywords: accupressure
vaccaria seeds
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of patients enrolled
timeFrame: 2 weeks
Secondary outcomes:
measure: Ease of participation in the study.
timeFrame: End of Study (Week 4)
Other outcomes:
measure: Accuracy of seed placement by a non-professional care partner.
timeFrame: Weekly until Week 4
measure: The change of the intervention prehabilitation results
timeFrame: End of Study (Week 4)
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Maria Lucia Madariaga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.