Prostate CancerAcuProNCT04172649
Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy
A study testing Acupuncture and Acupressure in people with Prostate Cancer and Perioperative Pain, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostate Cancer, Perioperative Pain
- What is being tested?
- Acupuncture and Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Prostate Cancer, Perioperative Pain
- Being tested
- Acupuncture, Acupressure
- Keywords
- prostate cancer, pain management, acupuncture, acupressure
- Medical subject headings
- Prostatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Acu Arm | Experimental | press tack needle acupuncture (ACU) and routine postoperative analgesic care Receives: Other: Acupuncture |
| SHAM Arm | Sham comparator | press tack placebo acupressure (SHAM) and routine postoperative analgesic care Receives: Other: Acupressure |
| CONTROL Arm | No intervention | Patients in the control group will receive only routine postoperative analgesic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: postoperative day three
Secondary outcomes (3)
Cumulative use (sum in mg) of routine postoperative analgesics
Cumulative use (sum in mg) of routine postoperative analgesics
Measured: postoperative day three
Time to first defecation following surgery
Time to first defecation following surgery
Measured: 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.
Measured: 7 days after catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Mar 2020
- Primary completion9 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Seirin Corporation, Shizuoka City, Japan
- Responsible party
- Sponsor
- Investigators
- Hans Heinzer, Prof., Principal investigator, Vice Medical Director and Faculty member of Martini-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172649
- Sponsor's protocol ID
- AcuPro 09.2019
- Other IDs
- DRK S00019884
- Acronym
- AcuPro
- Status last verified
- Apr 2023
- First submitted
- 13 Nov 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04172649
- Acronym / sponsor ID
- AcuPro / AcuPro 09.2019
- Conditions
- Prostate Cancer, Perioperative Pain
- Keywords
- prostate cancer, pain management, acupuncture, acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Collaborators
- Seirin Corporation, Shizuoka City, Japan
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acu Arm | Experimental | Other: Acupuncturepress tack needle acupuncture (ACU) and routine postoperative analgesic care |
| SHAM Arm | Sham comparator | Other: Acupressurepress tack placebo acupressure (SHAM) and routine postoperative analgesic care |
| CONTROL Arm | No intervention | –Patients in the control group will receive only routine postoperative analgesic care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureOn 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). | Other | Acu Arm |
| AcupressureOn 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). | Other | SHAM Arm |
Primary outcome
Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)
Time frame: postoperative day three
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).
3 secondary outcomes
Cumulative use (sum in mg) of routine postoperative analgesics
Time frame: postoperative day three
Time to first defecation following surgery
Time frame: postoperative day three
EQ-5D-5L for quality of life
Time frame: 7 days after catheter removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Heinzer, Prof. principal investigator
Vice Medical Director and Faculty member of Martini-Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Acupressure in people with Prostate Cancer and Perioperative Pain, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity measured by Numeric Rating Scale (NRS-11) (time frame: postoperative day three). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.