Clinical trial NCT06978816: Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Official title: Auricular Acupoint Embedding as Adjunctive Therapy to NSAIDs for Accelerated Relief of Renal Colic in Urolithiasis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Colic
Acupuncture, Ear
Keywords: Kidney Calculi
Renal Colic
acupuncture, ear
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate of Visual Analog Scale (VAS) reduction
timeFrame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Secondary outcomes:
measure: Incidence of adverse reactions
timeFrame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
measure: body temperature
timeFrame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
measure: Blood pressure
timeFrame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
measure: Heart rate
timeFrame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Other outcomes:
Locations:
Study officials:
References: