"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02821442|
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Acupuncture Device: Sham Acupuncture||Not Applicable|
A double blind prospective randomized controlled pilot study with cross over.
To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.
Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.
Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA).
Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients
Sham Comparator: Sham Acupuncture
Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on.
Device: Sham Acupuncture
Placebo needles appear to penetrate but do not actually penetrate the skin
- S-Lanss (short- Leads assessment of neuropathic symptoms and signs) [ Time Frame: 2 years ]16 point pain questionnaire that differentiates nociceptive from neuropathic pain
- VAS (Visual Analogue Scale) [ Time Frame: 2 years ]10 point verbal rating pain scale to measure participants pain in each assessment
- DASH (Disabilities of the arm, shoulder, hand) [ Time Frame: 2 years ]30 item questionnaire measuring upper limb function
- LEFS (Lower extremity functional scale) [ Time Frame: 2 years ]20 item questionnaire measuring lower limb function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821442
|Contact: Elizabeth Hammond, M.Sc.||firstname.lastname@example.org|
|Contact: Barbara Shay, PhDemail@example.com|
|University of Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada, R3E 0T6|
|Contact: Barbara Shay, PhD 204 977 5636 Barbara.Shay@med.umanitoba.ca|
|Principal Investigator: Barbara L Shay, PhD|
|Principal Investigator:||Barbara Shay, PhD||University of Manitoba|