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

Primary Purpose

Prostate Cancer, Perioperative Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acupuncture
Acupressure
Sponsored by
Martini-Klinik am UKE GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, pain management, acupuncture, acupressure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Martini-Klinik am UKE GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Acu Arm

SHAM Arm

CONTROL Arm

Arm Description

press tack needle acupuncture (ACU) and routine postoperative analgesic care

press tack placebo acupressure (SHAM) and routine postoperative analgesic care

Patients in the control group will receive only routine postoperative analgesic care

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cumulative use (sum in mg) of routine postoperative analgesics
Cumulative use (sum in mg) of routine postoperative analgesics
Time to first defecation following surgery
Time to first defecation following surgery
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.

Full Information

First Posted
November 13, 2019
Last Updated
April 11, 2023
Sponsor
Martini-Klinik am UKE GmbH
Collaborators
Seirin Corporation, Shizuoka City, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT04172649
Brief Title
Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy
Acronym
AcuPro
Official Title
A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Martini-Klinik am UKE GmbH
Collaborators
Seirin Corporation, Shizuoka City, Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Perioperative Pain
Keywords
prostate cancer, pain management, acupuncture, acupressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acu Arm
Arm Type
Experimental
Arm Description
press tack needle acupuncture (ACU) and routine postoperative analgesic care
Arm Title
SHAM Arm
Arm Type
Sham Comparator
Arm Description
press tack placebo acupressure (SHAM) and routine postoperative analgesic care
Arm Title
CONTROL Arm
Arm Type
No Intervention
Arm Description
Patients in the control group will receive only routine postoperative analgesic care
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)
Description
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).
Time Frame
postoperative day three
Secondary Outcome Measure Information:
Title
Cumulative use (sum in mg) of routine postoperative analgesics
Description
Cumulative use (sum in mg) of routine postoperative analgesics
Time Frame
postoperative day three
Title
Time to first defecation following surgery
Description
Time to first defecation following surgery
Time Frame
postoperative day three
Title
EQ-5D-5L for quality of life
Description
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.
Time Frame
7 days after catheter removal

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Heinzer, Prof.
Organizational Affiliation
Vice Medical Director and Faculty member of Martini-Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martini-Klinik am UKE GmbH
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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