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NCT Number: NCT03331055

PENS or TENS for Pain in Pancreatic Cancer

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

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Key information

Conditions

Pain Cancer Pain Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms 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

  • Pancreatic 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 pancreatic cancer;
  • Can not tolerate 30 min of lieing in prostrate or side position;
  • PS>3;
  • Who has been recruited in other clinical trial for pain releiving;
  • Who underwent radiotherapy or local radiactive seeds implantation for pain releiving 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. visal analogue scale (VAS) score

    Time frame: D0-D6

    VAS score before,during and 3 days after treatment

Secondary outcomes

  1. quantity of analgesic medication

    Time frame: D0-D6

    decreasing in quantity of analgesic medication

  2. times of breakthrough pain (BTP)

    Time frame: D0-D6

    times of BTP per day before,during and 3 days after treatment

Other outcomes

  1. complications

    Time frame: D1-D2

    any correlated complications happen during or after 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 Pancreatic Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 6, 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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