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| ID | Type | Description | Link |
|---|---|---|---|
| DRK S00019884 | Registry Identifier | German Clinical Trials Register |
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| Name | Class |
|---|---|
| Seirin Corporation, Shizuoka City, Japan | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acu Arm | Experimental | press tack needle acupuncture (ACU) and routine postoperative analgesic care |
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| SHAM Arm | Sham Comparator | press tack placebo acupressure (SHAM) and routine postoperative analgesic care |
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| CONTROL Arm | No Intervention | Patients in the control group will receive only routine postoperative analgesic care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
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
Prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Hans Heinzer, Prof. | Vice Medical Director and Faculty member of Martini-Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martini-Klinik am UKE GmbH | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
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| Acupressure | Other | 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). |
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |