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Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain

Unknown statusNot applicableNCT03828864
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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®.

Study details

Official title
Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
Interventions
  • Device: Pulsed Shortwave Therapy
  • Device: Placebo Pulsed Shortwave Therapy
Sponsor
BioElectronics Corporation
Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Start date
2019-02-01
Primary completion
2020-02-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03828864