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Trial registered on ANZCTR


Registration number
ACTRN12619000136101
Ethics application status
Approved
Date submitted
22/01/2019
Date registered
30/01/2019
Date last updated
21/01/2020
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the Effects of the ‘Actipatch’ Pulsed Shortwave Therapy Device in a Chronic Low Back Pain Population at an Australian Pain Management Centre
Scientific title
Investigation of the Effects of the ‘Actipatch’ Pulsed Shortwave Therapy Device in a Chronic Low Back Pain Population at an Australian Pain Management Centre on Pain, Function and Associated Issues
Secondary ID [1] 297095 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 311214 0
Condition category
Condition code
Musculoskeletal 309839 309839 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 309840 309840 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ActiPatch® is a TGA and FDA approved battery powered device and is sold over the counter. It emits a high frequency pulsed electromagnetic field.. The radiation is low level and undetectable by conscious sensation with no reported adverse effects. The power density at the skin surface is between 14 and 73 uW/cm2. Non-thermal effects of electromagnetic field exposure are due to the induced electric field in the tissue and not the magnetic field. ActiPatch produces an induced electric field of typically 10 milliVolt/cm. There is no ionizing radiation so output is 0 (zero) Sieverts. It can be applied over most parts of the body with reported analgesia and is also claimed to ameliorate central sensitisation that may underlie some chronic pain conditions.
The device can be used in the presence of underlying metallic implants, wounds, pacemakers and applied over the skin, or affixed over clothing or dressings, thereby having a broad range of applications and potential uses. During the trial the device is applied over the lumbar (low back) area.
The device is recommended to be used from 16 to 24 hours per day for optimal benefit and the trial will aim for daily use for a minimum of 16 hours per day use of the device over a 30 day period. The device has an on/off switch. When turned on, a green light turn is emitted. In the case of the sham device this light will appear when the on switch is turned “on” but the electromagnetic field will not be engaged. To determine if the device has been used as per recommendations and to check for any changes in other treatments during the trial a questionnaire will be provided at the end of the trial.
Intervention code [1] 313436 0
Treatment: Devices
Comparator / control treatment
Placebo: The active device produces a field that is not consciously perceivable and the sham device (that produces no electromagnetic field) is the same in every other way to the active device.
Control group
Placebo

Outcomes
Primary outcome [1] 318794 0
Brief Pain Inventory (Short form) (BPI-SF) questionnaire
Timepoint [1] 318794 0
Questionnaire delivered on day one that device is applied and again after 30 days of usage
Primary outcome [2] 318795 0
Patient Specific Functional Scale
Timepoint [2] 318795 0
Questionnaire delivered on day one that device is applied and again after 30 days of usage
Secondary outcome [1] 366065 0
Central Sensitisation Inventory – short form (CSI-9)
Timepoint [1] 366065 0
Questionnaire delivered on day one that device is applied and again after 30 days of usage
Secondary outcome [2] 366066 0
Pain Sleep Questionnaire PSQ-3
Timepoint [2] 366066 0
Questionnaire delivered on day one that device is applied and again after 30 days of usage
Secondary outcome [3] 366120 0
Post trial Questionnaire: This is a composite outcome measure specifically designed for this study and assesses the confidence of participants to use the device to aid in medication reduction. It will also assess adherence to the intervention (hours per day, days per week, if use was ceased, and if any changes to usual treatment occurred - pharmacological and non pharmacological) and success of blinding to the active or sham nature of the device used in the trial.
Timepoint [3] 366120 0
Questionnaire delivered after 30 days of usage

Eligibility
Key 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.
• Greater than 3 months duration of chronic low back pain i.e. cut off period for acute pain
• A current BPI pain rating greater than 5/10 on one 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered devices
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation - groups of ten sequentially numbered devices containing equal numbers of sham & active devices
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a dropout rate of 10% from pre- to post-intervention, the total sample required is 142 and is calculated as follows: The sample size is based on the mean between-group difference in pre-post intervention change scores for the primary outcome, using a two-tailed test with a = 0.05 and power = 0.8. Each group will require 64 participants in order to detect a moderate effect, operationalised a standardised mean difference of 0.5. This value of 0.5 is commonly used for patient-reported outcomes in the absence of results from previous similar trials, and corresponds to a 1-point change in the VAS, assuming a standard deviation of 2, which has been observed in normative data for pain intensity.
Primary and secondary outcomes will be examined using analysis of covariance on the pre-post intervention change scores. Condition (interventions vs. control) will be the independent variable of primary interest, and we will control for several covariates, including baseline scores for the outcomes and demographic and disease-related variables. Analysis will be intention-to-treat. Participants without a post-intervention score will be excluded from the analysis, but their baseline scores on all relevant variables will be compared to those with post-intervention scores to identify any differences that may contribute to bias in the results

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/02/2019
Actual
5/03/2019
Date of last participant enrolment
Anticipated
20/12/2021
Actual
Date of last data collection
Anticipated
20/01/2022
Actual
Sample size
Target
128
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12975 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25454 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 301662 0
Hospital
Name [1] 301662 0
Royal Prince Alfred Hospital Pain Management Centre
Country [1] 301662 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Pain Management Centre
Royal Prince Alfred Hospital
Level 4
Queen Elizabeth 2 Building
59 Missenden Road
Camperdown 2050
NSW
Country
Australia
Secondary sponsor category [1] 301464 0
None
Name [1] 301464 0
Not applicable
Address [1] 301464 0
Not applicable
Country [1] 301464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302382 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 302382 0
Ethics committee country [1] 302382 0
Australia
Date submitted for ethics approval [1] 302382 0
Approval date [1] 302382 0
13/12/2018
Ethics approval number [1] 302382 0
X18-0425 & HREC/18/RPAH/605

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90038 0
Mr Graeme Campbell
Address 90038 0
Pain Management Centre
Royal Prince Alfred Hospital
Queen Elizabeth 2 Building
59 Missenden Rd
Camperdown 2050
NSW
Country 90038 0
Australia
Phone 90038 0
+61,02,95159016
Fax 90038 0
61-02-95159831
Email 90038 0
graeme.campbell1@health.nsw.gov.au
Contact person for public queries
Name 90039 0
Graeme Campbell
Address 90039 0
Pain Management Centre
Royal Prince Alfred Hospital
Queen Elizabeth 2 Building
59 Missenden Rd
Camperdown 2050
NSW
Country 90039 0
Australia
Phone 90039 0
+61,02,95159016
Fax 90039 0
61-02-95159831
Email 90039 0
graeme.campbell1@health.nsw.gov.au
Contact person for scientific queries
Name 90040 0
Graeme Campbell
Address 90040 0
Pain Management Centre
Royal Prince Alfred Hospital
Queen Elizabeth 2 Building
59 Missenden Rd
Camperdown 2050
NSW
Country 90040 0
Australia
Phone 90040 0
+61,02,95159016
Fax 90040 0
61-02-95159831
Email 90040 0
graeme.campbell1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.