PENS or TENS for Pain in Liver 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 liver 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 Liver Cancer

Conditions
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Pain, Cancer Pain, Liver Neoplasms

Intervention / Treatment
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* Device: PENS
* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary liver 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 liver cancer; Can not tolerate a flat or side lying or sitting prostrate for 30 min; performance score>3; Who has been recruited in other clinical trial for pain relieving; Who underwent radiotherapy or local radioactive seeds implantation for pain relieving 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 liver cancer pain.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: percutaneous stimulation<br>PENS in 2/100 hertz (HZ), 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: transcutaneous stimulation<br>TENS in 2/100 HZ, 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 |
| --- | --- | --- |
| pain score | pain score assessed via visual analogue scale (VAS) | day0 to day6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantity of analgesic medication | decreasing in quantity of analgesic medication | day0 to Day6 | 
| times of breakthrough pain (BTP) | times of BTP per day | day0 to day6 | 

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