NCT04172649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

November 13, 2019

Last Update Submit

April 11, 2023

Conditions

Prostate CancerPerioperative Pain

Keywords

prostate cancerpain managementacupunctureacupressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cumulative use (sum in mg) of routine postoperative analgesics

    postoperative day three

  • Time to first defecation following surgery

    postoperative day three

  • EQ-5D-5L for quality of life

    7 days after catheter removal

Study Arms (3)

Acu Arm

EXPERIMENTAL

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

Other: Acupuncture

SHAM Arm

SHAM COMPARATOR

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

Other: Acupressure

CONTROL Arm

NO INTERVENTION

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

Interventions

AcupunctureOTHER

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).

Acu Arm
AcupressureOTHER

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).

SHAM Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to understand the terms of this study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Prostatic NeoplasmsAgnosia

Interventions

Acupuncture TherapyAcupressure

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hans Heinzer, Prof.

    Vice Medical Director and Faculty member of Martini-Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 21, 2019

Study Start

March 1, 2020

Primary Completion

April 9, 2021

Study Completion

December 31, 2021

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)