ActiPatch Therapy for Back Pain

May 10, 2016 updated by: University of Oxford

A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • John Radcliffe Hospital
        • Contact:
        • Principal Investigator:
          • Tipu Z Aziz
        • Sub-Investigator:
          • Laurie Pycroft

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Pulsed shortwave therapy (active)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain-related disability, indexed by the Oswestry Disability Index (ODI)
Time Frame: Change from baseline ODI score at 2 weeks
Change from baseline ODI score at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Change from baseline EQ-5D-5L scores at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Study record dates

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 Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (ESTIMATE)

November 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/LO/0926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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