PENS or TENS for Pain in Pancreatic Cancer

September 10, 2019 updated by: Fuda Cancer Hospital, Guangzhou

Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510665
        • Fuda Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: percutaneous stimulation
PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
Device: PENS
percutaneous electrical nerve stimulation
EXPERIMENTAL: trancutaneous stimulation
TENS in 2/100HZ, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visal analogue scale (VAS) score
Time Frame: D0-D6
VAS score before,during and 3 days after treatment
D0-D6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantity of analgesic medication
Time Frame: D0-D6
decreasing in quantity of analgesic medication
D0-D6
times of breakthrough pain (BTP)
Time Frame: D0-D6
times of BTP per day before,during and 3 days after treatment
D0-D6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: D1-D2
any correlated complications happen during or after procedure
D1-D2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Investigators

  • Study Chair: Lizhi Niu, Dr., Fuda Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2017

Primary Completion (ACTUAL)

April 26, 2018

Study Completion (ACTUAL)

August 26, 2019

Study Registration Dates

First Submitted

October 28, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-TCM-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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