Replies to post #66417 on Bioelectronics Corp (BIEL)

[seven-up]

LMAO-ClinicalTrials.gov-A-service-of-the-U.S.-National-Institutes of Health

ActiPatch Therapy for Back Pain
This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Oxford
Sponsor:
University of Oxford
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02601807
First received: October 21, 2015
Last updated: November 6, 2015
Last verified: November 2015
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. However there is no class 1 evidence for this on back pain. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at two weeks, the efficacy or otherwise can be established. Low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.

Condition Intervention
Back Ache
Device: ActiPatch (active)
Device: ActiPatch (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
Pain-related disability, indexed by the Oswestry Disability Index (ODI) [ Time Frame: Change from baseline ODI score at 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Subjective pain, indexed by Visual analogue pain scale [ Time Frame: Change from baseline visual analogue score over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary ] [ Designated as safety issue: No ]
Medication intake [ Time Frame: Change from baseline medication intake rate over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary ] [ Designated as safety issue: No ]
Pain related disability, indexed by the Roland Morris Instrument [ Time Frame: Change from baseline Roland Morris Instrument scores at 2 weeks ] [ Designated as safety issue: No ]
Quality of life, indexed by the EQ-5D-5L questionnaire [ Time Frame: Change from baseline EQ-5D-5L scores at 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2015
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
Subjects given active ActiPatch device before or after crossover (randomised)
Device: ActiPatch (active)
Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.
Other Name: Pulsed shortwave therapy (placebo)
Placebo Comparator: Placebo
Subjects given placebo ActiPatch device before or after crossover (randomised)
Device: ActiPatch (placebo)
Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.
Other Name: Pulsed shortwave therapy (active)

Eligibility

Ages Eligible for Study: 18 Years to 90 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the trial.
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Male or female ages 18-90 years old with stable chronic low back pain
≥3 months duration of chronic low back pain
a current VAS pain rating ≥5/10
no radiating pain below the knee
≥75% back or buttock pain rather than lower extremity pain
Able to complete and tolerate treatment for the study period.
Exclusion Criteria:

Female participant who is pregnant
Significant renal or hepatic impairment.
Prior home use of pulsed shortwave therapy
Prior history of spinal fusion or failed spinal surgery syndrome.
Laminectomy, laminotomy or discectomy within 12 months of enrollment.
Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency neuroablation within 6 months of enrollment.
Any addition of strong opiates, pregabalin and gabapentin to the treatment regime during the course of the trial
Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.
Patients using personal home based electrical stimulation devices
Patients with other concomitant illnesses (e.g., malignancy, osteoporosis) which, in the opinion of the investigator, would preclude successful patient participation will also be excluded
Active psychiatric disorders (as evidenced by use of antipsychotic or medication).
Patients diagnosed with history of significant mood disorder will be excluded (depression or anxiety with adequate control would be acceptable).
Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
Participant with life expectancy of less than 6 months, or inappropriate for placebo medication.
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Participants who are not able to understand verbal or written English, and for whom adequate translation/interpretation cannot be readily obtained.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02601807

Contacts
Contact: Tipu Z Aziz 01865231885 [e-mail]
Contact: Laurie Pycroft 07788804011 [e-mail]

Locations
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Tipu Z Aziz 01865231885 [e-mail]
Principal Investigator: Tipu Z Aziz
Sub-Investigator: Laurie Pycroft
Sponsors and Collaborators
University of Oxford
More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02601807 History of Changes
Other Study ID Numbers: 15/LO/0926
Study First Received: October 21, 2015
Last Updated: November 6, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Back
Pain
PSWT
ActiPatch
Pulsed shortwave therapy

ClinicalTrials.gov processed this record on December 14, 2015

TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CONTACT NLM HELP DESK
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services

[edbi46]

This might be approved this year in Dec. or in first 6 months of 2016 and the stock might be $1.25 easy. Biel might buy back most of the stock when everybody sells off at .30 - .50 cents and this company will skyrocket like VNDA .. I owned that stock for years before it went from .40 to $9.40 in one day .. $$$$$$ Go Biel be patient......this is from one of the poster's on Yahoo and in my opinion it is VERY POSSIBLE!!!!!!!!!!!!!

[edbi46]

Can you provide PROOF you called FDA and someone spoke to you about BIEL indirect and gave you a classified information about the company???