- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828864
Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain (PSWT)
Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Graeme Campbell
- Phone Number: (02) 95159016
- Email: graeme.campbell1@health.nsw.gov.au
Study Contact Backup
- Name: Arun Aggarwal, Prof
- Phone Number: 02 9515 9870
- Email: arun.a@sydney.edu.au
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Other Names:
|
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.
|
Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
30 days
|
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 |
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Graeme Campbell, Royal Prince Alfred Hospital, Sydney, Australia
- Study Chair: Arun Aggarwal, Professor, Royal Prince Alfred Hospital, Sydney, Australia
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X18-0425
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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