PENS or TENS for Pain in Pancreatic Cancer

NCT ID: NCT03331055

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2019-08-26

Brief Summary

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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

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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.

Conditions

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Pain Cancer Pain Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients with pancreatic cancer pain
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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percutaneous stimulation

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

Group Type EXPERIMENTAL

PENS

Intervention Type DEVICE

percutaneous electrical nerve stimulation

trancutaneous stimulation

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

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

transcutaneous electrical nerve stimulation

Control

Conventional analgesic medication is offered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PENS

percutaneous electrical nerve stimulation

Intervention Type DEVICE

TENS

transcutaneous electrical nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lizhi Niu, Dr.

Role: STUDY_CHAIR

Fuda Cancer Hospital

Locations

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Fuda Cancer Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 22419313 (View on PubMed)

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.

Reference Type RESULT
PMID: 26121600 (View on PubMed)

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.

Reference Type RESULT
PMID: 24280575 (View on PubMed)

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.

Reference Type RESULT
PMID: 26468973 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33592831 (View on PubMed)

Other Identifiers

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2017-TCM-01

Identifier Type: -

Identifier Source: org_study_id

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