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ActiPatch Therapy for Back Pain

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ClinicalTrials.gov Identifier: NCT02601807
Recruitment Status : Unknown
Verified May 2016 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : November 10, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE October 21, 2015
First Posted Date  ICMJE November 10, 2015
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
Pain-related disability, indexed by the Oswestry Disability Index (ODI) [ Time Frame: Change from baseline ODI score at 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02601807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
  • 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 ]
  • 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 ]
  • Pain related disability, indexed by the Roland Morris Instrument [ Time Frame: Change from baseline Roland Morris Instrument scores at 2 weeks ]
  • Quality of life, indexed by the EQ-5D-5L questionnaire [ Time Frame: Change from baseline EQ-5D-5L scores at 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ActiPatch Therapy for Back Pain
Official Title  ICMJE A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Back Ache
Intervention  ICMJE
  • Device: ActiPatch (active)
    Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.
    Other Name: Pulsed shortwave therapy (placebo)
  • 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)
Study Arms  ICMJE
  • Active Comparator: Active
    Subjects given active ActiPatch device before or after crossover (randomised)
    Intervention: Device: ActiPatch (active)
  • Placebo Comparator: Placebo
    Subjects given placebo ActiPatch device before or after crossover (randomised)
    Intervention: Device: ActiPatch (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 6, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02601807
Other Study ID Numbers  ICMJE 15/LO/0926
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Oxford
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP