Acupressure as Complementary Analgesia in Shock Wave Lithotripsy

NCT07885696 | Recruiting DMC

• 1 other identifier: 1255364
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Calculi; Urolithiasis; ESWL; Acupressure; Pain Score (VAS)

Keywords

acupressure; eswl; pain score

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 10, 20, 30, and 40 minutes during ESWL, and at the end of the procedure.

Secondary Outcomes (3)

• Procedural Intolerance

  Up to the end of the procedure (approximately 45 minutes).

• Need for Rescue Analgesia

  During the ESWL procedure.

• Patient Satisfaction

  At the end of the procedure.

Study Arms (3)

Acupressure Group

EXPERIMENTAL

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

Sham Group

SHAM COMPARATOR

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

Control Group

NO INTERVENTION

Patients receive standard ESWL protocol without any additional intervention or touching before the procedure.

Interventions

Acupressure BEHAVIORAL

Rhythmic thumb pressure applied to LI4 (Hegu) and Qiu points at a subjective intensity of warmth/heaviness without causing pain.

Acupressure Group

Sham Acupressure BEHAVIORAL

Superficial touch mimicking the duration and location of acupressure without applying therapeutic pressure.

Sham Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for ESWL due to kidney or proximal ureteral stones.
• First-time ESWL patients.
• Age ≥ 18 years.

You may not qualify if:

• Kidney anomaly (e.g., horseshoe kidney) or severe hydronephrosis.
• Morbid obesity.
• Chronic neuropathic disease that may affect pain perception or neural response to acupressure.
• Use of any analgesics within \[12/24\] hours prior to the procedure.
• Use of anticoagulants.
• Impaired skin integrity (wound, infection, tenderness) at the acupressure application sites (LI4 or Qiu).
• Amputation of the relevant extremity.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

istanbul başakşehir Çam Sakura city hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Ziaei Azarkhavarani F, Rejeh N, Valiani M, Kazemi R. Effect of acupressure on pain among older female patients undergoing extracorporeal shock wave lithotripsy: A randomized controlled clinical trial. Explore (NY). 2024 Mar-Apr;20(2):233-238. doi: 10.1016/j.explore.2023.07.010. Epub 2023 Aug 2.

  PMID: 37573221 RESULT

• Safdari A, Khazaei S, Biglarkhani M, Mousavibahar SH, Borzou SR. Effect of acupressure on pain intensity and physiological indices in patients undergoing extracorporeal shock wave lithotripsy: a randomized double-blind sham-controlled clinical trial. BMC Complement Med Ther. 2024 Jan 25;24(1):55. doi: 10.1186/s12906-024-04360-1.

  PMID: 38273233 RESULT

MeSH Terms

Conditions

Urinary Calculi; Urolithiasis

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

ALi İhsan memmi, medical doctor

CONTACT

+90 5379220977; alimemmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients assigned to the acupressure and sham groups will be blinded to their specific intervention. To achieve effective masking, the sham intervention is designed to perfectly mimic the true acupressure procedure; it is performed by the same practitioner, targets the identical anatomical points (bilateral LI4 and stone-side Qiu), utilizes the same patient positioning, and lasts for the exact same duration (9 minutes). The only difference is the application of superficial touch without therapeutic pressure, making it indistinguishable to the patient. Due to the lack of a physical intervention, patients in the control group are aware of their allocation (open-label). Additionally, the healthcare personnel responsible for assessing and recording the outcomes (Visual Analogue Scale scores and hemodynamic parameters), as well as the physician performing the Extracorporeal Shock Wave Lithotripsy (ESWL) procedure, will be strictly blinded to the group assignments. The practitioner applying
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: October 3, 2026
• First Posted: October 21, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)