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Clinical Trials/NCT03338543
NCT03338543CompletedNot Applicable

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

Fuda Cancer Hospital, Guangzhou1 site in 1 country36 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
pain score

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

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.

Intervention: PENS (Device)

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.

Intervention: TENS (Device)

Control

No Intervention

Conventional analgesic medication is offered.

Outcomes

Primary Outcomes

pain score

Time Frame: day0 to day6

pain score assessed via visual analogue scale (VAS)

Secondary Outcomes

  • quantity of analgesic medication(day0 to Day6)
  • times of breakthrough pain (BTP)(day0 to day6)

Investigators

Sponsor
Fuda Cancer Hospital, Guangzhou
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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