PENS or TENS for Pain in Liver Cancer

Not Applicable

Completed

• Conditions: Cancer Pain; Pain; Liver Neoplasms
• Interventions: Device: PENS; Device: TENS

• Registration Number: NCT03338543
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-10-31
• Study Start: 2017-11-01
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Primary Completion: 2018-04-30
• Status Verified: 2018-10
• Study Completion: 2019-08-30
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous stimulation	PENS	PENS in 2/100 hertz (HZ), 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.
transcutaneous stimulation	TENS	TENS in 2/100 HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary.

Primary Outcome Measures

Name	Time	Method
pain score	day0 to day6	pain score assessed via visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
quantity of analgesic medication	day0 to Day6	decreasing in quantity of analgesic medication
times of breakthrough pain (BTP)	day0 to day6	times of BTP per day

Trial Locations

Locations (1)

Fuda Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China