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

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ClinicalTrials.gov Identifier: NCT03828864
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Royal Prince Alfred Hospital, Sydney, Australia
Information provided by (Responsible Party):
BioElectronics Corporation

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®.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Pulsed Shortwave Therapy Device: Placebo Pulsed Shortwave Therapy Not Applicable

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®.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.
Primary Purpose: Treatment
Official Title: Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Active Pulsed Shortwave therapy
Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.
Device: Pulsed Shortwave Therapy
Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Other Name: ActiPatch

Placebo Comparator: Placebo Pulsed Shortwave therapy
Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.
Device: Placebo Pulsed Shortwave Therapy
Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Other Name: Placebo ActiPatch




Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) Short Form [ Time Frame: 30 days ]

    The BPI-SF is a questionnaire - self-administered or by interview - that assesses both pain intensity and pain interference in common aspects of one's life. It has reliability & validity across cultural and language groups & is one of the standard measures used by the national Electronic Persistent Pain Outcomes Collaboration (ePPOC) that collates data from various Pain Management Centres to evaluate outcomes in pain clinics Australia wide.

    Scoring

    Question answers are complied into two categories:

    1. Pain severity is 0 - 10, with 10 being worst pain possible
    2. Pain inference score is 0 - 10, with 10 being worst possible pain inference


Secondary Outcome Measures :
  1. Central Sensitisation Inventory - short form (CSI-9) [ Time Frame: 30 days ]

    Central Sensitisation (CS) is thought to be one underlying mechanism for the prevalence of chronic pain and the ActiPatch® device is believed to reduce central sensitization. Use of the CSI-9 will be used to assess the extent to which central sensitization is present in the study cohort and if use of the device produces a change in CS. This will then allow appraisal of the role of central sensitization in any outcomes achieved.

    Scoring, scores are totaled from the assessment Five severity levels (subclinical = 0-29, mild = 30-39, moderate = 40-49, severe = 50-59, and severe = 60-100) central sensitization


  2. Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance [ Time Frame: 30 days ]

    The interaction between sleep disturbance and chronic pain is widely reported in the literature, and is thought to be a two way interaction. Use of the PSQ-3 will be used to assess the extent to which perceived sleep disturbance is present in the study cohort and if use of the ActiPatch® device is associated with a change in sleep quality. Addressing sleep quality may help to treat chronic pain including LBP and thereby have clinical treatment applications.

    Scoring 0-30, 0 no sleep disturbance and 30 worst sleep disturbance Three visual analog scales of 0-10




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828864


Contacts
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Contact: Graeme Campbell (02) 95159016 graeme.campbell1@health.nsw.gov.au
Contact: Arun Aggarwal, Prof 02 9515 9870 arun.a@sydney.edu.au

Sponsors and Collaborators
BioElectronics Corporation
Royal Prince Alfred Hospital, Sydney, Australia
Investigators
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Principal Investigator: Graeme Campbell Royal Prince Alfred Hospital, Sydney, Australia
Study Chair: Arun Aggarwal, Professor Royal Prince Alfred Hospital, Sydney, Australia

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Responsible Party: BioElectronics Corporation
ClinicalTrials.gov Identifier: NCT03828864     History of Changes
Other Study ID Numbers: X18-0425
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms