PENS or TENS for Pain in Pancreatic Cancer

Pain Clinical Trial

Official title:

Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331055
• Other study ID #: 2017-TCM-01
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: August 26, 2019

Study information

• Verified date: October 2018
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 26, 2019
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cancer Pain
• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• PENS
percutaneous electrical nerve stimulation
• TENS
transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
China	Fuda Cancer Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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;(3):CD006276. doi: 10.1002/14651858.CD006276.pub3. Review. — View Citation

Paley CA, Johnson MI, Tashani OA, Bagnall AM. Acupuncture for cancer pain in adults. Cochrane Database Syst Rev. 2015 Oct 15;(10):CD007753. doi: 10.1002/14651858.CD007753.pub3. Review. — View 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;(6):CD009389. doi: 10.1002/14651858.CD009389.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complications	any correlated complications happen during or after procedure	D1-D2
Primary	visal analogue scale (VAS) score	VAS score before,during and 3 days after treatment	D0-D6
Secondary	quantity of analgesic medication	decreasing in quantity of analgesic medication	D0-D6
Secondary	times of breakthrough pain (BTP)	times of BTP per day before,during and 3 days after treatment	D0-D6