Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief

Gao Xiaofeng

Status: Not yet enrolling

Conditions: Acupuncture, Ear; Renal Colic

Treatments: Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS); Other: Sham Acupoint Embedding; Other: Auricular Acupoint Embedding

Study type: Interventional

Funder types: Other

Identifiers

NCT06978816

CHC2025-130

Details and patient eligibility

About

Title: Can Ear Acupressure Help Relieve Kidney Stone Pain Faster When Combined with Painkillers?

Purpose:

This study tests whether adding ear acupressure to standard painkillers (NSAIDs) helps adults with kidney stone pain feel better faster. The investigators also want to know if this combination causes any side effects.

Key Questions:

Does ear acupressure + NSAIDs reduce pain more quickly than NSAIDs alone? Are there any safety concerns with this treatment? How does real ear acupressure compare to a fake (placebo) procedure? Who Can Join? Adults aged 18-75 Experiencing moderate-to-severe kidney stone pain (confirmed by CT or ultrasound) No recent painkiller use or allergies to NSAIDs

What Participants Will Do:

Receive in the emergency room:

Real treatment: Tiny needles placed on 3 ear points + NSAIDs (ketorolac injection) OR Placebo treatment: Fake tape on ear points + NSAIDs (same injection) Rate their pain on a 0-10 scale over 60 minutes. Have their heart rate and blood pressure checked.

Study Details:

Duration: Single ER visit (no long-term follow-up) Participants Needed: 116 Safety: Rescue pain medication (like morphine) is available if needed.

Why This Matters:

Kidney stones cause severe pain, and current painkillers may not work fast enough. Ear acupressure is a low-risk method from traditional Chinese medicine that could provide quicker relief.

Ethics:

Approved by Changhai Hospital's Ethics Committee. Participants can leave the study anytime.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 15 and 75 years (inclusive)
2. Diagnosis of urinary tract stones confirmed by CT or ultrasound
3. Visual Analog Scale (VAS) score ≥ 4 (indicating moderate to severe renal colic)
4. No severe cardiac, hepatic, or pulmonary dysfunction, and no coagulation disorders.
5. No psychiatric disorders

Exclusion criteria

1. Use of any analgesic medication within the past 6 hours.
2. Allergy to NSAIDs, morphine, or anisodamine (scopolamine derivatives)
3. History of asthma, urticaria, congestive heart failure, acute ischemic heart disease, acute cerebrovascular disease, or increased intracranial pressure
4. Active peptic ulcer, pyloric obstruction, or intestinal obstruction
5. Severe adverse reactions to acupuncture in the past
6. Pregnancy or lactation
7. Unwillingness to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

Verum Auricular Acupoint Embedding Group

Experimental group

Description:

In the experimental group, patients received verum auricular acupoint embedding using disposable sterile press needles (0.22×0.5 mm) at three ipsilateral ear points - thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1) - combined with intravenous infusion of 50 mg dexketoprofen trometamol (a non-steroidal anti-inflammatory drug) as adjuvant therapy.

Treatment:

Other: Auricular Acupoint Embedding

Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS)

Sham Auricular Acupoint Embedding Group

Sham Comparator group

Description:

In the control group, participants received sham auricular stimulation using non-penetrating adhesive patches applied to the same ipsilateral ear points (thalamus \[MA-AT\], kidney \[MA-SC\], and shenmen \[MA-TF1\]) without needle insertion, combined with identical intravenous administration of 50 mg dexketoprofen trometamol (NSAID) as per the experimental protocol

Treatment:

Other: Sham Acupoint Embedding

Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS)