ActiPatch Therapy for Back Pain

NCT ID: NCT02601807

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31

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.

Conditions

Back Ache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Subjects given active ActiPatch device before or after crossover (randomised)

Group Type: ACTIVE_COMPARATOR

ActiPatch (active)

Intervention Type: DEVICE

Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.

Placebo

Subjects given placebo ActiPatch device before or after crossover (randomised)

Group Type: PLACEBO_COMPARATOR

ActiPatch (placebo)

Intervention Type: DEVICE

Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.

Interventions

ActiPatch (active)

Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.

Intervention Type: DEVICE

ActiPatch (placebo)

Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.

Intervention Type: DEVICE

Other Intervention Names

Pulsed shortwave therapy (placebo); Pulsed shortwave therapy (active)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Tipu Z Aziz

Role: CONTACT

tipu.aziz@nds.ox.ac.uk

01865231885

Laurie Pycroft

Role: CONTACT

laurie.pycroft@nds.ox.ac.uk

07788804011

Facility Contacts

Tipu Z Aziz

Role: primary

tipu.aziz@nds.ox.ac.uk

01865231885

Other Identifiers

15/LO/0926

Identifier Type: -

Identifier Source: org_study_id