PENS or TENS for Pain in Pancreatic Cancer

Study Overview
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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.

Official Title
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Percutaneous Electrical Nerve Stimulation or Transcutaneous Electrical Nerve Stimulation for Pain in Patients With Pancreatic Cancer

Conditions
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Pain, Cancer Pain, Pancreatic Cancer

Intervention / Treatment
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* Device: PENS
* Device: TENS


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with pancreatic cancer pain
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: percutaneous stimulation<br>PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. | Device: PENS<br>* percutaneous electrical nerve stimulation<br>|
| Experimental: trancutaneous stimulation<br>TENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. | Device: TENS<br>* transcutaneous electrical nerve stimulation<br>|
| No Intervention: Control<br>Conventional analgesic medication is offered. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, percutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation, pancreatic cancer