Clinical trial NCT03331055: PENS or TENS for Pain in Pancreatic Cancer
Official title: Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Cancer Pain
Pancreatic Cancer
Keywords: percutaneous electrical nerve stimulation
transcutaneous electrical nerve stimulation
pain
pancreatic cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with pancreatic cancer pain
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Pancreatic cancer with pain;
* Haven't underwent neurolytic celiac plexus block in the past 1 month;
* With anticipatory survival of more than 3 months.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: visal analogue scale (VAS) score
timeFrame: D0-D6
Secondary outcomes:
measure: quantity of analgesic medication
timeFrame: D0-D6
measure: times of breakthrough pain (BTP)
timeFrame: D0-D6
Other outcomes:
measure: complications
timeFrame: D1-D2
Locations:
city: Guangzhou
country: China
facility: Fuda Cancer Hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: Peng 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.
citation: Chen 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.
citation: Paley 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.
citation: He 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.