PENS or TENS for Pain in Liver Cancer

Overview

This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with liver cancer. Patients will randomly allocated into PENS group, Tens group and control group.

Full Title of Study: “Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Liver Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: percutaneous stimulation
    • PENS in 2/100 hertz (HZ), 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
  • Experimental: transcutaneous stimulation
    • TENS in 2/100 HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
  • No Intervention: Control
    • Conventional analgesic medication is offered.

Clinical Trial Outcome Measures

Primary Measures

  • pain score
    • Time Frame: day0 to day6
    • pain score assessed via visual analogue scale (VAS)

Secondary Measures

  • quantity of analgesic medication
    • Time Frame: day0 to Day6
    • decreasing in quantity of analgesic medication
  • times of breakthrough pain (BTP)
    • Time Frame: day0 to day6
    • times of BTP per day

Participating in This Clinical Trial

Inclusion Criteria

  • Primary liver 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 liver cancer; – Can not tolerate a flat or side lying or sitting prostrate for 30 min; – performance score>3; – Who has been recruited in other clinical trial for pain relieving; – Who underwent radiotherapy or local radioactive seeds implantation for pain relieving in the past month; – Imaging diagnosed with encephalic tumor or metastasis; – Who with cardiac pacemaker or metal stand;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lizhi Niu, Dr., Study Chair, Fuda Cancer Hospital

References

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.

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.

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.

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.

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