Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy
NCT ID: NCT04172649
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2020-03-01
2021-12-31
Brief Summary
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The investigator will also investigate whether or not acupuncture with needle skin penetration is more efficacious than acupressure.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acu Arm
press tack needle acupuncture (ACU) and routine postoperative analgesic care
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 Arm
press tack placebo acupressure (SHAM) and routine postoperative analgesic care
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).
CONTROL Arm
Patients in the control group will receive only routine postoperative analgesic care
No interventions assigned to this group
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
MALE
No
Sponsors
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Seirin Corporation, Shizuoka City, Japan
UNKNOWN
Martini-Klinik am UKE GmbH
OTHER
Responsible Party
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Principal Investigators
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Hans Heinzer, Prof.
Role: PRINCIPAL_INVESTIGATOR
Vice Medical Director and Faculty member of Martini-Klinik
Locations
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Martini-Klinik am UKE GmbH
Hamburg, , Germany
Countries
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Other Identifiers
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DRK S00019884
Identifier Type: REGISTRY
Identifier Source: secondary_id
AcuPro 09.2019
Identifier Type: -
Identifier Source: org_study_id
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