NCT03338543

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 12, 2019

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 31, 2017

Last Update Submit

September 10, 2019

Conditions

PainCancer PainLiver Neoplasms

Keywords

percutaneous electrical nerve stimulationtranscutaneous electrical nerve stimulationpainliver cancerhepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • pain score

    pain score assessed via visual analogue scale (VAS)

    day0 to day6

Secondary Outcomes (2)

  • quantity of analgesic medication

    day0 to Day6

  • times of breakthrough pain (BTP)

    day0 to day6

Other Outcomes (1)

  • complications

    day1 to day3

Study Arms (3)

percutaneous stimulation

EXPERIMENTAL

PENS in 2/100 hertz (HZ), 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.

Device: PENS

transcutaneous stimulation

EXPERIMENTAL

TENS in 2/100 HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.

Device: TENS

Control

NO INTERVENTION

Conventional analgesic medication is offered.

Interventions

PENSDEVICE

percutaneous electrical nerve stimulation

percutaneous stimulation
TENSDEVICE

transcutaneous electrical nerve stimulation

transcutaneous stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

Related Publications (4)

  • 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.

    PMID: 22419313BACKGROUND

  • 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.

    PMID: 26121600BACKGROUND

  • 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.

    PMID: 24280575BACKGROUND

  • 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.

    PMID: 26468973BACKGROUND

MeSH Terms

Conditions

PainCancer PainLiver NeoplasmsCarcinoma, Hepatocellular

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Lizhi Niu, Dr.

    Fuda Cancer Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participant is allocated randomly by staff A, and grouping situation is concealed; Technician (stuff B) or chargeing docotor operates PENS or TENS, or administers oral analgesic medication; Related datas are collected according to perdetermined forms by stuff C; Outcomes are assessed by stuff D.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients with liver cancer pain.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 9, 2017

Study Start

November 1, 2017

Primary Completion

April 30, 2018

Study Completion

August 30, 2019

Last Updated

September 12, 2019

Record last verified: 2018-10

Locations

CN(1)