Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review.
Claire Shuiqing Zhang, Angela Weihong Yang, Anthony Lin Zhang...
https://pubmed.ncbi.nlm.nih.gov/24138333/Actively Recruiting
Led by University of Chicago · Updated on 2025-12-09
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the use of auricular acupressure to enhance overall health and prehabilitation benefits in patients preparing for major lung surgery. This study focuses on adults aged 50 years or older who are candidates for lung procedures such as wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy. Auricular acupuncture, which targets specific points on the ear, has shown benefits in managing pain, sleep disturbances, fatigue, and mood issues, making it a promising approach for preoperative support. Participants will be randomly assigned to either an experimental group receiving auricular acupressure at specific therapeutic points or a control group receiving sham acupressure at non-therapeutic points. The acupressure seeds will be placed during a clinic visit, with instructions given to the patient and their care partner on how to press the seeds to apply pressure for two minutes per point. The seeds are removed before the patient leaves the clinic. This intervention is designed to be used during a prehabilitation period lasting at least two weeks before surgery. During the study, patients and their care partners will participate in seed placement and pressing as demonstrated by the research staff. The study will monitor enrollment numbers over two weeks and assess the ease of participation by the end of four weeks. Patients must be able to perform spirometry testing and have access to a smartphone for communication and image sharing. The study includes follow-up assessments focused on the patients ability to take part in the intervention and the overall impact on prehabilitation efforts.
CONDITIONS
Auricular Acupressure in Prehabilitation
M
Maria Lucia Madariaga, MD
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University of Chicago
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Auricular Acupressure | Sham Acupressure |
|---|---|---|
| What it is | Application of special seeds to specific points on the ear, pressed regularly by the patient and care partner, supervised by a study team member. | Placement of seeds on the ear to mimic the intervention without targeting known acupressure points, applied in a way that appears similar but lacks specific therapeutic intention. |
| Role in the trial | Evaluates whether targeted auricular acupressure before lung surgery can affect preparation and recovery for adults with frailty undergoing major surgery. | Controls for placebo effects and participant expectations, providing a comparison to measure the true effect of targeted auricular acupressure. |
| Primary use | Investigational intervention for supporting surgical preparation and recovery in frail adults undergoing lung surgery. | Placebo-like procedure to provide an active control for comparative purposes in the study. |
| How it is given or performed | Seeds are placed on specific ear points by a team member; the patient and care partner practice applying pressure to the seeds for two minutes each, with guidance, then all seeds are removed before leaving clinic. | Seeds are applied to non-acupressure points on the ear, with the same demonstration and pressing steps for face validity, then removed in the same way as the intervention group. |
| Evidence status | Currently being evaluated in a clinical trial for acceptability and ability to enroll participants prior to major lung surgery; no trial results have been posted. | Serves as the comparator; no outcome data yet available. |
| Important limitations | Effectiveness for improving prehabilitation outcomes before lung surgery is not established; results may not generalize beyond the studied population. | Does not provide therapeutic acupressure stimulation and may not be entirely inert due to touch and expectation effects. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 weeks prior to surgery
Participants receive auricular acupressure with seeds placed on specific points by an acupuncturist or research associate. The care partner observes seed placement and practices pressing the seeds alongside the participant. Seeds are pressed for 2 minutes each and removed prior to clinic discharge.
1 clinic visit for seed placement and removal
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Claire Shuiqing Zhang, Angela Weihong Yang, Anthony Lin Zhang...
https://pubmed.ncbi.nlm.nih.gov/24138333/Mark K Ferguson, Sydeaka Watson, Elizabeth Johnson...
https://pubmed.ncbi.nlm.nih.gov/24052607/University of Chicago
Lead Sponsor