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

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: Prostate Cancer; Perioperative Pain
• Intervention / Treatment: Other: Acupuncture; Other: Acupressure

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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	Cumulative use (sum in mg) of routine postoperative analgesics	postoperative day three
Time to first defecation following surgery	Time to first defecation following surgery	postoperative day three
EQ-5D-5L for quality of life	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

• 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

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: prostate cancer; acupuncture; pain management; acupressure
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• 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