ActiPatch Therapy for Back Pain

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

Study Description

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Tipu Z Aziz; 01865231885; tipu.aziz@nds.ox.ac.uk

Contact: Laurie Pycroft; 07788804011; laurie.pycroft@nds.ox.ac.uk

Locations

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

More Information

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT02601807
• Other Study ID Numbers: 15/LO/0926
• First Posted: November 10, 2015
• 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:

Back Pain; Pain; Neurologic Manifestations