An interventional study of Acupressure and Sham Acupressure in Acupressure, Urinary Calculi and Urolithiasis, sponsored by Medipol University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Medipol University · Not applicable, Interventional, and Supportive care
This study aims to evaluate the efficacy of acupressure applied to the LI4 (Hegu) and Qiu points before Extracorporeal Shock Wave Lithotripsy (ESWL) in patients with kidney or proximal ureteral stones. The study compares intraprocedural pain scores and procedural tolerance between an acupressure group, a sham acupressure group, and a standard care control group.
Extracorporeal shock wave lithotripsy (ESWL) is a widely used non-invasive treatment for urinary tract stones; however, procedure-related pain can lead to patient movement and irregular breathing, which may reduce treatment efficacy and cause premature termination of the session. To manage this pain without the adverse effects associated with pharmacological agents, this prospective, randomized, sham-controlled, three-arm clinical trial evaluates the analgesic efficacy of acupressure during ESWL. A total of 105 eligible adult patients scheduled for their first ESWL session will be randomly assigned in a 1:1:1 ratio to an acupressure group, a sham group, or a standard care control group. Immediately prior to the procedure, the acupressure group will receive rhythmic thumb pressure on the bilateral LI4 (Hegu) and stone-side Qiu points for a total of 9 minutes (3 minutes per point). The sham comparator group will receive superficial touch on the exact same points for the same duration without therapeutic pressure, effectively blinding the patients to the intervention. The control group will receive standard care with no additional pre-procedural physical intervention. Throughout the ESWL procedure, pain severity will be systematically monitored using a 10-cm Visual Analogue Scale (VAS) at baseline, 10, 20, 30, and 40 minutes, and at the end of the procedure. Additionally, secondary outcomes including procedural intolerance, the need for rescue analgesia, changes in hemodynamic parameters (heart rate and blood pressure), overall patient satisfaction, and stone-free rates at three weeks post-procedure will be recorded to determine if acupressure serves as a safe and effective complementary analgesic method.
160 studies on the registry are indexed under Urinary Calculi; 29 are open to participants now.
This study's planned enrollment of 105 is close to the median of 110 across 111 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Medipol University is the lead sponsor of 320 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Patients receive superficial touch without pressure on the identical points (bilateral LI4 and stone-side Qiu) for the same duration (9 minutes) immediately before ESWL.
Behavioral: Acupressure
Patients receive superficial touch without pressure on the identical points (bilateral LI4 and stone-side Qiu) for the same duration (9 minutes) immediately before ESWL.
Behavioral: Sham Acupressure
Patients receive standard ESWL protocol without any additional intervention or touching before the procedure.
Rhythmic thumb pressure applied to LI4 (Hegu) and Qiu points at a subjective intensity of warmth/heaviness without causing pain.
Superficial touch mimicking the duration and location of acupressure without applying therapeutic pressure.
Pain Severity Assessed by Visual Analogue Scale (VAS)
Patients self-reported pain intensity on a 10-cm horizontal line (0 = no pain, 10 = worst possible pain).
Time frame: Baseline, 10, 20, 30, and 40 minutes during ESWL, and at the end of the procedure.
Procedural Intolerance
Premature termination of the ESWL procedure before reaching the planned shock number due to severe pain.
Time frame: Up to the end of the procedure (approximately 45 minutes).
Need for Rescue Analgesia
Number of patients requiring additional analgesia (e.g., paracetamol/NSAID) during the procedure.
Time frame: During the ESWL procedure.
Patient Satisfaction
Evaluated via a 5-point Likert scale (1: very dissatisfied, 5: very satisfied).
Time frame: At the end of the procedure.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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