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PENS or TENS for Pain in Liver Cancer

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ClinicalTrials.gov Identifier: NCT03338543
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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.

Condition or disease Intervention/treatment Phase
Pain Cancer Pain Liver Neoplasms Device: PENS Device: TENS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients with liver cancer pain.
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.
Primary Purpose: Treatment
Official Title: Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Liver Cancer
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
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.
Device: PENS
percutaneous electrical nerve stimulation

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.
Device: TENS
transcutaneous electrical nerve stimulation

No Intervention: Control
Conventional analgesic medication is offered.



Primary Outcome Measures :
  1. pain score [ Time Frame: day0 to day6 ]
    pain score assessed via visual analogue scale (VAS)


Secondary Outcome Measures :
  1. quantity of analgesic medication [ Time Frame: day0 to Day6 ]
    decreasing in quantity of analgesic medication

  2. times of breakthrough pain (BTP) [ Time Frame: day0 to day6 ]
    times of BTP per day


Other Outcome Measures:
  1. complications [ Time Frame: day1 to day3 ]
    any correlated complications happen during procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338543


Contacts
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Contact: Lihua He, Dr. 86-20-38993912 quincyhe@163.com

Locations
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China, Guangdong
Fuda Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Lihua He, Dr.         
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, Dr. Fuda Cancer Hospital

Publications:
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03338543     History of Changes
Other Study ID Numbers: 2017-TCM-02
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fuda Cancer Hospital, Guangzhou:
percutaneous electrical nerve stimulation
transcutaneous electrical nerve stimulation
pain
liver cancer
hepatocellular carcinoma

Additional relevant MeSH terms:
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Liver Neoplasms
Cancer Pain
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Pain
Neurologic Manifestations
Signs and Symptoms