AcupressureNCT07885696
Acupressure as Complementary Analgesia in Shock Wave Lithotripsy
A study testing Acupressure in people with Acupressure and Urinary Calculi, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupressure, Urinary Calculi, Urolithiasis
- What is being tested?
- Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for ESWL due to kidney or proximal ureteral stones.
- First-time ESWL patients.
- Age ≥ 18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
istanbul başakşehir Çam Sakura city hospital
Istanbul
ali ihsan memmi, +905379220997, alimemmi@gmail.com
About this study
Official title: The Effect of Acupressure Application on Pain Scores and Procedure Tolerance in Extracorporeal Shock Wave Lithotripsy Treatment
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.
Read the detailed description
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.
- Conditions
- Acupressure, Urinary Calculi, Urolithiasis, ESWL, Pain Score (VAS)
- Being tested
- Acupressure, Sham Acupressure
- Keywords
- acupressure, eswl, pain score
- Medical subject headings
- Urinary Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureBehavioural
Rhythmic thumb pressure applied to LI4 (Hegu) and Qiu points at a subjective intensity of warmth/heaviness without causing pain.
Sham AcupressureBehavioural
Superficial touch mimicking the duration and location of acupressure without applying therapeutic pressure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Acupressure |
| Control Group | No intervention | Patients receive standard ESWL protocol without any additional intervention or touching before the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 10, 20, 30, and 40 minutes during ESWL, and at the end of the procedure.
Secondary outcomes (3)
Procedural Intolerance
Premature termination of the ESWL procedure before reaching the planned shock number due to severe pain.
Measured: 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.
Measured: During the ESWL procedure.
Patient Satisfaction
Evaluated via a 5-point Likert scale (1: very dissatisfied, 5: very satisfied).
Measured: At the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AcupressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885696
- Sponsor's protocol ID
- 1255364
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37573221Safdari 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.
PubMed 38273233
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Application on Pain Scores and Procedure Tolerance in Extracorporeal Shock Wave Lithotripsy Treatment
- ClinicalTrials.gov ID
- NCT07885696
- Acronym / sponsor ID
- 1255364
- Conditions
- Acupressure, Urinary Calculi, Urolithiasis, ESWL, Pain Score (VAS)
- Keywords
- acupressure, eswl, pain score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Behavioral: AcupressurePatients receive superficial touch without pressure on the identical points (bilateral LI4 and stone-side Qiu) for the same duration (9 minutes) immediately before ESWL. |
| Sham Group | Sham comparator | Behavioral: Sham AcupressurePatients receive superficial touch without pressure on the identical points (bilateral LI4 and stone-side Qiu) for the same duration (9 minutes) immediately before ESWL. |
| Control Group | No intervention | –Patients receive standard ESWL protocol without any additional intervention or touching before the procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for ESWL due to kidney or proximal ureteral stones.
- First-time ESWL patients.
- Age ≥ 18 years.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureRhythmic thumb pressure applied to LI4 (Hegu) and Qiu points at a subjective intensity of warmth/heaviness without causing pain. | Behavioural | Acupressure Group |
| Sham AcupressureSuperficial touch mimicking the duration and location of acupressure without applying therapeutic pressure. | Behavioural | Sham Group |
Primary outcome
Pain Severity Assessed by Visual Analogue Scale (VAS)
Time frame: Baseline, 10, 20, 30, and 40 minutes during ESWL, and at the end of the procedure.
Patients self-reported pain intensity on a 10-cm horizontal line (0 = no pain, 10 = worst possible pain).
3 secondary outcomes
Procedural Intolerance
Time frame: Up to the end of the procedure (approximately 45 minutes).
Need for Rescue Analgesia
Time frame: During the ESWL procedure.
Patient Satisfaction
Time frame: At the end of the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Results publication: PubMed 37573221Ziaei 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.
- Results publication: PubMed 38273233Safdari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Acupressure and Urinary Calculi, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALi İhsan memmi, medical doctor (+90 5379220977, alimemmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity Assessed by Visual Analogue Scale (VAS) (time frame: Baseline, 10, 20, 30, and 40 minutes during ESWL, and at the end of the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07885696, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.