None listed
Conditions
Brief summary
The ActiPatch is a small battery powered device that produces a very small electromagnetic field that you cannot feel but which early studies have found to be effective in some pain conditions. Our study aims to test what effects using this device has on pain in chronic low back pain and other aspects of the chronic pain experience. This will assist with knowing recommendations we should make to our patients about this device and how and when we might use it. As the device is relatively new on the market you would normally need to purchase this device so you will have the opportunity to trial this device at no cost to you.
Interventions
The ActiPatch® is a TGA and FDA approved battery powered device and is sold over the counter. It emits a high frequency pulsed electromagnetic field.. The radiation is low level and undetectable by conscious sensation with no reported adverse effects. The power density at the skin surface is between 14 and 73 uW/cm2. Non-thermal effects of electromagnetic field exposure are due to the induced electric field in the tissue and not the magnetic field. ActiPatch produces an induced electric field of
The ActiPatch® is a TGA and FDA approved battery powered device and is sold over the counter. It emits a high frequency pulsed electromagnetic field.. The radiation is low level and undetectable by conscious sensation with no reported adverse effects. The power density at the skin surface is between 14 and 73 uW/cm2. Non-thermal effects of electromagnetic field exposure are due to the induced electric field in the tissue and not the magnetic field. ActiPatch produces an induced electric field of typically 10 milliVolt/cm. There is no ionizing radiation so output is 0 (zero) Sieverts. It can be applied over most parts of the body with reported analgesia and is also claimed to ameliorate central sensitisation that may underlie some chronic pain conditions. The device can be used in the presence of underlying metallic implants, wounds, pacemakers and applied over the skin, or affixed over clothing or dressings, thereby having a broad range of applications and potential uses. During the trial the device is applied over the lumbar (low back) area. The device is recommended to be used from 16 to 24 hours per day for optimal benefit and the trial will aim for daily use for a minimum of 16 hours per day use of the device over a 30 day period. The device has an on/off switch. When turned on, a green light turn is emitted. In the case of the sham device this light will appear when the on switch is turned “on” but the electromagnetic field will not be engaged. To determine if the device has been used as per recommendations and to check for any changes in other treatments during the trial a questionnaire will be provided at the end of the trial.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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. • Male or female ages 18 or above with stable chronic lower back pain • Females of childbearing must be on birth control or practice abstinence during the study period. • In the event of possible pre-existing pregnancy, women of childbearing age will be screened with a urine pregnancy test. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. • Greater than 3 months duration of chronic low back pain i.e. cut off period for acute pain • A current BPI pain rating greater than 5/10 on one of the four pain VAS scales on the BPI • Most of the pain in the body is present in the lower back or buttock, NOT in the lower extremities, as determined during screening by the principal investigator. The investigator will verbally ask the participant if most of the pain being experienced is in the lower back/buttock area, and rely on the response for inclusion into the study. • Able to complete and tolerate treatment for the study period. • Pain stable in one area of the low back, i.e. not variable in location • Medication regime stable over the last 3 months
Exclusion criteria
• Female participant who is pregnant. • Subjects using personal home based electrical stimulation devices • Prior home use of pulsed shortwave therapy. i.e ActiPatch® • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. • Planned or scheduled variation in pain related medication (analgesic or psychoactive) regime during the course of the trial. • Active psychiatric disorders (e.g. participants using antipsychotic medication, with bipolar disorder or schizophrenia). • Subjects with other concomitant illnesses (e.g., malignancy) which, in the opinion of the investigator, would preclude successful subject participation • Subjects diagnosed with a history of significant mood disorder will be excluded (Note that subjects with depression or anxiety with adequate control would be acceptable). Participants would be required to be stable with their moods (EPPOC data or psychological or psychiatric evaluation can be referenced in the case of doubt) • 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 planning to change any other variables during the study period likely to affect their pain or function e.g. commencement of an exercise class; ceasing allied health treatment
Outcome results
None listed