Clinical trial NCT02601807: ActiPatch Therapy for Back Pain
Official title: A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Ache
Keywords: Back
Pain
PSWT
ActiPatch
Pulsed shortwave therapy
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain-related disability, indexed by the Oswestry Disability Index (ODI)
timeFrame: Change from baseline ODI score at 2 weeks
Secondary outcomes:
measure: Subjective pain, indexed by Visual analogue pain scale
timeFrame: 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
measure: Medication intake
timeFrame: 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
measure: Pain related disability, indexed by the Roland Morris Instrument
timeFrame: Change from baseline Roland Morris Instrument scores at 2 weeks
measure: Quality of life, indexed by the EQ-5D-5L questionnaire
timeFrame: Change from baseline EQ-5D-5L scores at 2 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
References: