Clinical trial NCT03828864: Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain
Official title: Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: BioElectronics Corporation
Sponsor class: INDUSTRY
Collaborators: name: Royal Prince Alfred Hospital, Sydney, Australia
First posted: 2019-02-04
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the efficacy of the ActiPatch® device by means of a randomized double blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.

Detailed description: This study aims to test the efficacy of the ActiPatch® device by means of a randomised double blind controlled trial in a convenience sample of chronic low back pain patients at Royal Prince Alfred Hospital (RPAH) pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.

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.
* 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.
* ≥3 months duration of chronic low back pain i.e. cut off period for acute pain
* a current BPI pain rating ≥5/10 on one of the 4 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

Primary outcomes:
measure: Brief Pain Inventory (BPI) Short Form
timeFrame: 30 days
Secondary outcomes:
measure: Central Sensitisation Inventory - short form (CSI-9)
timeFrame: 30 days
measure: Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Graeme Campbell
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Arun Aggarwal, Professor
role: STUDY_CHAIR
References: