Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy (AcuPro)

April 11, 2023 updated by: Martini-Klinik am UKE GmbH

A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy

Acupuncture has been shown in several meta-analyses and clinical studies, in different surgical settings and chronic back pain, to be a safe adjuvant option for postoperative pain treatment. In this study, the investigator hypothesize that acupuncture can decrease postoperative pain intensity and amount of given analgesics, and accelerate recovery of bowel motility, in patients after open radical prostatectomy.

The investigator will also investigate whether or not acupuncture with needle skin penetration is more efficacious than acupressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized, controlled and partially blinded study with three arms: 1) press tack needle acupuncture (ACU) and routine postoperative analgesic care, 2) press tack placebo acupressure (SHAM) and routine postoperative analgesic care, and 3) only routine postoperative analgesic care (CONTROL).

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Martini-Klinik am UKE GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males aged 18-70 years
  • Diagnosis with prostate cancer and scheduled for open radical prostatectomy
  • Ability and willingness to follow study instructions and complete all required questionnaires during hospitalization and follow-up
  • Written informed consent

Exclusion Criteria:

  • Inability to understand the terms of this study

  • Simultanously participation in other clinical trials possibly influencing primary or secondary endpoints or any acupuncture-related clinical trials within 30 days prior to inclusion

    • Prior surgery within the last three months
    • Received acupuncture within 6 weeks before surgery
    • Known hypersensitivity or fear of acupuncture
    • Known abuse of drugs, medications and alcohol
    • Chronic pain for more than 3 months
    • Continuous opioid analgesic medications for more than 3 days during the 4 weeks prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acu Arm
press tack needle acupuncture (ACU) and routine postoperative analgesic care
Other: Acupuncture
On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack needles (diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).
Sham Comparator: SHAM Arm
press tack placebo acupressure (SHAM) and routine postoperative analgesic care
Other: Acupressure
On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack placebos (knob without needle, diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).
No Intervention: CONTROL Arm
Patients in the control group will receive only routine postoperative analgesic care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)
Time Frame: postoperative day three
The primary outcome is to check the effects of permanent needle acupuncture at 6 acupuncture points for changing postoperative pain intensity as measured by the Numeric Rating Scale (NRS-11), calculated as area under the curve (AUC).
postoperative day three

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative use (sum in mg) of routine postoperative analgesics
Time Frame: postoperative day three
Cumulative use (sum in mg) of routine postoperative analgesics
postoperative day three
Time to first defecation following surgery
Time Frame: postoperative day three
Time to first defecation following surgery
postoperative day three
EQ-5D-5L for quality of life
Time Frame: 7 days after catheter removal
fill out a questionnaire: According to the website httpp://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ under the tab "User guide 5L", page 5 in a blue box, it states that EQ-5D-5L is not an abbreviation and should be used and quoted as is. The EQ-5D-5L questionnaire measures quality of life based on 5 different levels (no problems, slight problems, moderate problems, severe problems and extreme problems) to each of the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
7 days after catheter removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martini-Klinik am UKE GmbH

Collaborators

Seirin Corporation, Shizuoka City, Japan

Investigators

  • Principal Investigator: Hans Heinzer, Prof., Vice Medical Director and Faculty member of Martini-Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

April 9, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AcuPro 09.2019
  • DRK S00019884 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe