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

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed Shortwave Therapy
Placebo Pulsed Shortwave Therapy
Sponsored by
BioElectronics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Active Pulsed Shortwave therapy

    Placebo Pulsed Shortwave therapy

    Arm Description

    Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.

    Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.

    Outcomes

    Primary Outcome Measures

    Brief Pain Inventory (BPI) Short Form
    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: Pain severity is 0 - 10, with 10 being worst pain possible Pain inference score is 0 - 10, with 10 being worst possible pain inference

    Secondary Outcome Measures

    Central Sensitisation Inventory - short form (CSI-9)
    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
    Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance
    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

    Full Information

    First Posted
    February 1, 2019
    Last Updated
    February 1, 2019
    Sponsor
    BioElectronics Corporation
    Collaborators
    Royal Prince Alfred Hospital, Sydney, Australia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03828864
    Brief Title
    Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain
    Acronym
    PSWT
    Official Title
    Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2019 (Anticipated)
    Primary Completion Date
    February 1, 2020 (Anticipated)
    Study Completion Date
    May 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BioElectronics Corporation
    Collaborators
    Royal Prince Alfred Hospital, Sydney, Australia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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®.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.
    Allocation
    Randomized
    Enrollment
    142 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Pulsed Shortwave therapy
    Arm Type
    Active Comparator
    Arm Description
    Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.
    Arm Title
    Placebo Pulsed Shortwave therapy
    Arm Type
    Placebo Comparator
    Arm Description
    Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.
    Intervention Type
    Device
    Intervention Name(s)
    Pulsed Shortwave Therapy
    Other Intervention Name(s)
    ActiPatch
    Intervention Description
    Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
    Intervention Type
    Device
    Intervention Name(s)
    Placebo Pulsed Shortwave Therapy
    Other Intervention Name(s)
    Placebo ActiPatch
    Intervention Description
    Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
    Primary Outcome Measure Information:
    Title
    Brief Pain Inventory (BPI) Short Form
    Description
    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: Pain severity is 0 - 10, with 10 being worst pain possible Pain inference score is 0 - 10, with 10 being worst possible pain inference
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Central Sensitisation Inventory - short form (CSI-9)
    Description
    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
    Time Frame
    30 days
    Title
    Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance
    Description
    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
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Graeme Campbell
    Phone
    (02) 95159016
    Email
    graeme.campbell1@health.nsw.gov.au
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arun Aggarwal, Prof
    Phone
    02 9515 9870
    Email
    arun.a@sydney.edu.au
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Graeme Campbell
    Organizational Affiliation
    Royal Prince Alfred Hospital, Sydney, Australia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Arun Aggarwal, Professor
    Organizational Affiliation
    Royal Prince Alfred Hospital, Sydney, Australia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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