ActiPatch Therapy for Back Pain

NCT02601807 | Unknown DMC

• 1 other identifier: 15/LO/0926
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Back; Pain; PSWT; ActiPatch; Pulsed shortwave therapy

Outcome Measures

Primary Outcomes (1)

• Pain-related disability, indexed by the Oswestry Disability Index (ODI)

  Change from baseline ODI score at 2 weeks

Secondary Outcomes (4)

• Subjective pain, indexed by Visual analogue pain scale

  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

  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

  Change from baseline Roland Morris Instrument scores at 2 weeks

• Quality of life, indexed by the EQ-5D-5L questionnaire

  Change from baseline EQ-5D-5L scores at 2 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Device: ActiPatch (active)

Placebo

PLACEBO COMPARATOR

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

Device: ActiPatch (placebo)

Interventions

ActiPatch (active) DEVICE

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

Also known as: Pulsed shortwave therapy (placebo)

Active

ActiPatch (placebo) DEVICE

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

Also known as: Pulsed shortwave therapy (active)

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Back Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tipu Z Aziz

CONTACT

01865231885; tipu.aziz@nds.ox.ac.uk

Laurie Pycroft

CONTACT

07788804011; laurie.pycroft@nds.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: November 10, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

GB (1)