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NCT Number: NCT03338543

PENS or TENS for Pain in Liver Cancer

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.

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Key information

Conditions

Pain Adenocarcinoma Cancer Pain Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

PENS

Device

percutaneous electrical nerve stimulation

TENS

Device

transcutaneous electrical nerve stimulation

Primary outcomes

  1. pain score

    Time frame: day0 to day6

    pain score assessed via visual analogue scale (VAS)

Secondary outcomes

  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 outcomes

  1. complications

    Time frame: day1 to day3

    any correlated complications happen during procedure

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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