PainNCT03331055
PENS or TENS for Pain in Pancreatic Cancer
A study testing PENS and TENS in people with Pain and Cancer Pain, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic cancer. Patients will randomly allocated into PENS group, Tens group and control group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Cancer Pain, Pancreatic Cancer
- What is being tested?
- PENS and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2017to 26 Aug 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic cancer with pain;
- Haven't underwent neurolytic celiac plexus block in the past 1 month;
- With anticipatory survival of more than 3 months.
Who cannot join
- Metastatic pancreatic cancer;
- Can not tolerate 30 min of lieing in prostrate or side position;
- PS>3;
- Who has been recruited in other clinical trial for pain releiving;
- Who underwent radiotherapy or local radiactive seeds implantation for pain releiving in the past month;
- Imaging diagnosed with encephalic tumor or metastasis;
- Who with cardiac pacemaker or metal stand;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer
This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic cancer. Patients will randomly allocated into PENS group, Tens group and control group.
Read the detailed description
PENS and TENS have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on.
Effect and mechanism of PENS on pain relieving has been widely researched. With additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. However, invasive operation limits its application and acceptability, especially on pancreatic cancer.
TENS is an advanced technique generated from PENS, which is much more welcome for its noninvasive character. Further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.
- Conditions
- Pain, Cancer Pain, Pancreatic Cancer
- Being tested
- PENS, TENS
- Keywords
- percutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation, pain, pancreatic cancer
- Medical subject headings
- Pain, Cancer Pain, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENSDevice
percutaneous electrical nerve stimulation
TENSDevice
transcutaneous electrical nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| percutaneous stimulation | Experimental | PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. Receives: Device: PENS |
| trancutaneous stimulation | Experimental | TENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. Receives: Device: TENS |
| Control | No intervention | Conventional analgesic medication is offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visal analogue scale (VAS) score
VAS score before,during and 3 days after treatment
Measured: D0-D6
Secondary outcomes (2)
quantity of analgesic medication
decreasing in quantity of analgesic medication
Measured: D0-D6
times of breakthrough pain (BTP)
times of BTP per day before,during and 3 days after treatment
Measured: D0-D6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start27 Oct 2017
- Primary completion26 Apr 2018
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Model description
- patients with pancreatic cancer pain
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, Dr., Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331055
- Sponsor's protocol ID
- 2017-TCM-01
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3.
PubMed 22419313Peng L, Min S, Zejun Z, Wei K, Bennett MI. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD009389. doi: 10.1002/14651858.CD009389.pub3.
PubMed 26121600Chen H, Liu TY, Kuai L, Zhu J, Wu CJ, Liu LM. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial. Pancreatology. 2013 Nov-Dec;13(6):594-7. doi: 10.1016/j.pan.2013.10.007. Epub 2013 Oct 23.
PubMed 24280575Paley CA, Johnson MI, Tashani OA, Bagnall AM. Acupuncture for cancer pain in adults. Cochrane Database Syst Rev. 2015 Oct 15;2015(10):CD007753. doi: 10.1002/14651858.CD007753.pub3.
PubMed 26468973He L, Tan K, Lin X, Yi H, Wang X, Zhang J, Lin J, Lin L. Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain. Medicine (Baltimore). 2021 Feb 5;100(5):e23748. doi: 10.1097/MD.0000000000023748.
PubMed 33592831
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03331055
- Acronym / sponsor ID
- 2017-TCM-01
- Conditions
- Pain, Cancer Pain, Pancreatic Cancer
- Keywords
- percutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation, pain, pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 6 Nov 2017 (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.
This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic cancer. Patients will randomly allocated into PENS group, Tens group and control group.
Detailed description
PENS and TENS have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on.
Effect and mechanism of PENS on pain relieving has been widely researched. With additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. However, invasive operation limits its application and acceptability, especially on pancreatic cancer.
TENS is an advanced technique generated from PENS, which is much more welcome for its noninvasive character. Further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- patients with pancreatic cancer pain
| Arm | Type | Receives |
|---|---|---|
| percutaneous stimulation | Experimental | Device: PENSPENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. |
| trancutaneous stimulation | Experimental | Device: TENSTENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. |
| Control | No intervention | –Conventional analgesic medication is offered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pancreatic cancer with pain;
- Haven't underwent neurolytic celiac plexus block in the past 1 month;
- With anticipatory survival of more than 3 months.
Key exclusion criteria (7 listed)
- Metastatic pancreatic cancer;
- Can not tolerate 30 min of lieing in prostrate or side position;
- PS>3;
- Who has been recruited in other clinical trial for pain releiving;
- Who underwent radiotherapy or local radiactive seeds implantation for pain releiving in the past month;
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 |
|---|---|---|
| PENSpercutaneous electrical nerve stimulation | Device | percutaneous stimulation |
| TENStranscutaneous electrical nerve stimulation | Device | trancutaneous stimulation |
Primary outcome
visal analogue scale (VAS) score
Time frame: D0-D6
VAS score before,during and 3 days after treatment
2 secondary outcomes
quantity of analgesic medication
Time frame: D0-D6
times of breakthrough pain (BTP)
Time frame: D0-D6
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 12 Sep 2019.
- Results publication: PubMed 22419313Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3.
- Results publication: PubMed 26121600Peng L, Min S, Zejun Z, Wei K, Bennett MI. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD009389. doi: 10.1002/14651858.CD009389.pub3.
- Results publication: PubMed 24280575Chen H, Liu TY, Kuai L, Zhu J, Wu CJ, Liu LM. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial. Pancreatology. 2013 Nov-Dec;13(6):594-7. doi: 10.1016/j.pan.2013.10.007. Epub 2013 Oct 23.
- Results publication: PubMed 26468973Paley CA, Johnson MI, Tashani OA, Bagnall AM. Acupuncture for cancer pain in adults. Cochrane Database Syst Rev. 2015 Oct 15;2015(10):CD007753. doi: 10.1002/14651858.CD007753.pub3.
- Derived from this study: PubMed 33592831He L, Tan K, Lin X, Yi H, Wang X, Zhang J, Lin J, Lin L. Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain. Medicine (Baltimore). 2021 Feb 5;100(5):e23748. doi: 10.1097/MD.0000000000023748.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Lizhi Niu, Dr. study chair
Fuda Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENS and TENS in people with Pain and Cancer Pain, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
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 3 inclusion and 7 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 12 Sep 2019. 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 China. 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. 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?
visal analogue scale (VAS) score (time frame: D0-D6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331055, which also lists 5 linked publications.
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 12 Sep 2019.