search
Back to results

PENS or TENS for Pain in Pancreatic Cancer

Primary Purpose

Pain, Cancer Pain, Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PENS
TENS
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring percutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation, pain, pancreatic cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Fuda Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

percutaneous stimulation

trancutaneous stimulation

Control

Arm Description

PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.

TENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.

Conventional analgesic medication is offered.

Outcomes

Primary Outcome Measures

visal analogue scale (VAS) score
VAS score before,during and 3 days after treatment

Secondary Outcome Measures

quantity of analgesic medication
decreasing in quantity of analgesic medication
times of breakthrough pain (BTP)
times of BTP per day before,during and 3 days after treatment

Full Information

First Posted
October 28, 2017
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
search

1. Study Identification

Unique Protocol Identification Number
NCT03331055
Brief Title
PENS or TENS for Pain in Pancreatic Cancer
Official Title
Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
August 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cancer Pain, Pancreatic Cancer
Keywords
percutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation, pain, pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with pancreatic cancer pain
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
percutaneous stimulation
Arm Type
Experimental
Arm Description
PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
Arm Title
trancutaneous stimulation
Arm Type
Experimental
Arm Description
TENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional analgesic medication is offered.
Intervention Type
Device
Intervention Name(s)
PENS
Intervention Description
percutaneous electrical nerve stimulation
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
transcutaneous electrical nerve stimulation
Primary Outcome Measure Information:
Title
visal analogue scale (VAS) score
Description
VAS score before,during and 3 days after treatment
Time Frame
D0-D6
Secondary Outcome Measure Information:
Title
quantity of analgesic medication
Description
decreasing in quantity of analgesic medication
Time Frame
D0-D6
Title
times of breakthrough pain (BTP)
Description
times of BTP per day before,during and 3 days after treatment
Time Frame
D0-D6
Other Pre-specified Outcome Measures:
Title
complications
Description
any correlated complications happen during or after procedure
Time Frame
D1-D2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, Dr.
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuda Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22419313
Citation
Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3.
Results Reference
result
PubMed Identifier
26121600
Citation
Peng L, Min S, Zejun Z, Wei K, Bennett MI. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD009389. doi: 10.1002/14651858.CD009389.pub3.
Results Reference
result
PubMed Identifier
24280575
Citation
Chen H, Liu TY, Kuai L, Zhu J, Wu CJ, Liu LM. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial. Pancreatology. 2013 Nov-Dec;13(6):594-7. doi: 10.1016/j.pan.2013.10.007. Epub 2013 Oct 23.
Results Reference
result
PubMed Identifier
26468973
Citation
Paley CA, Johnson MI, Tashani OA, Bagnall AM. Acupuncture for cancer pain in adults. Cochrane Database Syst Rev. 2015 Oct 15;2015(10):CD007753. doi: 10.1002/14651858.CD007753.pub3.
Results Reference
result
PubMed Identifier
33592831
Citation
He L, Tan K, Lin X, Yi H, Wang X, Zhang J, Lin J, Lin L. Multicenter, randomized, double-blind, controlled trial of transcutaneous electrical nerve stimulation for pancreatic cancer related pain. Medicine (Baltimore). 2021 Feb 5;100(5):e23748. doi: 10.1097/MD.0000000000023748.
Results Reference
derived

Learn more about this trial

PENS or TENS for Pain in Pancreatic Cancer

We'll reach out to this number within 24 hrs