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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

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.

Condition or disease Intervention/treatment Phase
Back Ache Device: ActiPatch (active) Device: ActiPatch (placebo) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2015
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Pain-related disability, indexed by the Oswestry Disability Index (ODI) [ Time Frame: Change from baseline ODI score at 2 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Pain related disability, indexed by the Roland Morris Instrument [ Time Frame: Change from baseline Roland Morris Instrument scores at 2 weeks ]
  4. Quality of life, indexed by the EQ-5D-5L questionnaire [ Time Frame: Change from baseline EQ-5D-5L scores at 2 weeks ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): NCT02601807


Contacts
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Contact: Tipu Z Aziz 01865231885 tipu.aziz@nds.ox.ac.uk
Contact: Laurie Pycroft 07788804011 laurie.pycroft@nds.ox.ac.uk

Locations
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United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Tipu Z Aziz    01865231885    tipu.aziz@nds.ox.ac.uk   
Principal Investigator: Tipu Z Aziz         
Sub-Investigator: Laurie Pycroft         
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02601807     History of Changes
Other Study ID Numbers: 15/LO/0926
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by University of Oxford:
Back
Pain
PSWT
ActiPatch
Pulsed shortwave therapy
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms