Chronic Low Back PainPSWTNCT03828864
Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain
A study testing Pulsed Shortwave Therapy in people with Chronic Low Back Pain, run by BioElectronics Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Pulsed Shortwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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).
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
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®.
Read the 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®.
- Conditions
- Chronic Low Back Pain
- Being tested
- Pulsed Shortwave Therapy, Placebo Pulsed Shortwave Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Shortwave TherapyDevice
Also called ActiPatch
Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Placebo Pulsed Shortwave TherapyDevice
Also called Placebo ActiPatch
Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
| Study group | Role | What they receive |
|---|---|---|
| Active Pulsed Shortwave therapy | Active comparator | Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain. Receives: Device: Pulsed Shortwave Therapy |
| Placebo Pulsed Shortwave therapy | Placebo comparator | Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain. Receives: Device: Placebo Pulsed Shortwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
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
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioElectronics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Prince Alfred Hospital, Sydney, Australia
- Responsible party
- Sponsor
- Investigators
- Graeme Campbell, Principal investigator, Royal Prince Alfred Hospital, Sydney, AustraliaArun Aggarwal, Professor, Study chair, Royal Prince Alfred Hospital, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828864
- Sponsor's protocol ID
- X18-0425
- Acronym
- PSWT
- Status last verified
- Jan 2019
- First submitted
- 1 Feb 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03828864
- Acronym / sponsor ID
- PSWT / X18-0425
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- BioElectronics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Royal Prince Alfred Hospital, Sydney, Australia
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Pulsed Shortwave therapy | Active comparator | Device: Pulsed Shortwave TherapyApplication of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain. |
| Placebo Pulsed Shortwave therapy | Placebo comparator | Device: Placebo Pulsed Shortwave TherapyApplication of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Shortwave TherapyAlso: ActiPatchPulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day | Device | Active Pulsed Shortwave therapy |
| Placebo Pulsed Shortwave TherapyAlso: Placebo ActiPatchPlacebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day | Device | Placebo Pulsed Shortwave therapy |
Primary outcome
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
2 secondary outcomes
Central Sensitisation Inventory - short form (CSI-9)
Time frame: 30 days
Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graeme Campbell principal investigator
Royal Prince Alfred Hospital, Sydney, Australia
Arun Aggarwal, Professor study chair
Royal Prince Alfred Hospital, Sydney, Australia
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Shortwave Therapy in people with Chronic Low Back Pain, run by BioElectronics Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graeme Campbell ((02) 95159016, graeme.campbell1@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) Short Form (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.