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2017-10-27
2018-04-26
2019-08-26
36
NCT03331055
Fuda Cancer Hospital, Guangzhou
Fuda Cancer Hospital, Guangzhou
INTERVENTIONAL
PENS or TENS for Pain in Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-10-28 | N/A | 2019-09-10 |
2017-10-31 | N/A | 2019-09-12 |
2017-11-06 | N/A | 2018-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: percutaneous stimulation PENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. | DEVICE: PENS
|
| EXPERIMENTAL: trancutaneous stimulation TENS in 2/100HZ, 30 min for each time, twice a day, for 3 days. With conventional analgesic medication if necessary. | DEVICE: TENS
|
| NO_INTERVENTION: Control Conventional analgesic medication is offered. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| visal analogue scale (VAS) score | VAS score before,during and 3 days after treatment | D0-D6 |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
