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Trial registered on ANZCTR


Registration number
ACTRN12615000236594
Ethics application status
Approved
Date submitted
24/02/2015
Date registered
16/03/2015
Date last updated
3/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Electromagnetic Millimetre Wave Therapy for pain relief
Scientific title
Comparing pain levels before and after Electromagnetic Millimetre Wave Therapy (EMT) in patients presenting with chronic pain
Secondary ID [1] 286254 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain experienced for longer than 1 month 294307 0
Condition category
Condition code
Musculoskeletal 294632 294632 0 0
Other muscular and skeletal disorders
Neurological 294633 294633 0 0
Other neurological disorders
Injuries and Accidents 294634 294634 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electromagnetic Millimetre Wave Therapy (EMT), originally developed in Russia, has shown promise in pain relief therapy in several randomised controlled trials conducted in the USA and Europe in the last 15 years. EMT was shown to be effective in reducing painful conditions, including joint pain, headache, postoperative pain, and neuropathic pain.
EMT involves a local exposure of the skin (2-3 cm2) to low power electromagnetic waves (<20mW/cm2) in the millimetre range (30-300GHz).
Phase 1: Consenting patients will holds the device on Day 1 once for 15 minutes either to the localised area of pain or, in case of systemic pain, to the sternum.
Phase 2: Treatment is to be repeated 4x a week on every 2nd day as per protocols in the literature.
EMT may have three main effects: (i) sedative and analgesic; (ii) anti-inflammatory action and enhancement of tissue generation processes and (iii) immune stimulation.
Intervention code [1] 291272 0
Treatment: Devices
Comparator / control treatment
Intra-individual pain after intervention compared to before
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294398 0
Pain levels assessed by
Q1a. visual analogue validated 11-point scale (Farrar 2001)
Q1b. type of pain (multiple choice, developed for this study)
Q2. location and severity of pain (developed by C. Dunlop for this study)
Q3. quality of life/ validated pain self-efficacy scale (Nicholas 1998)
Timepoint [1] 294398 0
Day 1: 10 minutes after EMT treatment
Primary outcome [2] 294399 0
Pain levels assessed by
Q1a. visual analogue validated 11-point scale (Farrar 2001)
Q1b. type of pain (multiple choice, developed for this study)
Q2. location and severity of pain (developed by C. Dunlop for this study)
Q3. quality of life/ validated pain self-efficacy scale (Nicholas 1998)
Timepoint [2] 294399 0
Phase 1: Day 2 after EMT treatment Day 3 after EMT treatment Day 4 after EMT treatment
Phase 2: Every day for 1 week, days 2-7.
Secondary outcome [1] 313192 0
Safety/ tolerability: blood pressure
Timepoint [1] 313192 0
during 15 min EMT treatment
Secondary outcome [2] 313401 0
Safety/ tolerability: heart rate
Timepoint [2] 313401 0
during 15 min EMT treatment

Eligibility
Key inclusion criteria
Adults 18-80 years, presenting with pain experienced for at least 1 month
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
acute pain (< 1 month)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
On the basis of their history of pain, a health practitioner will select and approach patients to participate in the study. Consenting patients will receive 15 minutes of EMT treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an exploratory pilot study. We aim to recruit 2x20 patients presenting with any type of pain (e.g. localised muscular skeletal or systemic neurological pain). Phase 1: Patients will receive only one EMT session (n=20). Phase 2: Patients will receive 4x weekly EMT sessions every 2nd day (n=20). The protocol will be adjusted in accordance with recruitment and findings. The pilot study will provide mean changes and standard deviations needed for future sample size calculations.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
31/03/2015
Actual
3/08/2015
Date of last participant enrolment
Anticipated
31/01/2022
Actual
23/01/2020
Date of last data collection
Anticipated
28/02/2022
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9278 0
3122 - Hawthorn West

Funding & Sponsors
Funding source category [1] 290815 0
Self funded/Unfunded
Name [1] 290815 0
Country [1] 290815 0
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
21 Burwood Rd, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 289501 0
None
Name [1] 289501 0
Address [1] 289501 0
Country [1] 289501 0
Other collaborator category [1] 278366 0
Individual
Name [1] 278366 0
Prof Iain Wallace
Address [1] 278366 0
Emeritus Professor
Swinburne University
PO Box 218
Hawthorn, VIC 3122
Country [1] 278366 0
Australia
Other collaborator category [2] 278367 0
Individual
Name [2] 278367 0
Prof Avni Sali
Address [2] 278367 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country [2] 278367 0
Australia
Other collaborator category [3] 278384 0
Individual
Name [3] 278384 0
Prof Nguyen Tran
Address [3] 278384 0
Industrial Research Institute of Swinburne
Swinburne University
PO Box 218
Hawthorn, VIC 3122
Country [3] 278384 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292440 0
NIIM HREC
Ethics committee address [1] 292440 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Ethics committee country [1] 292440 0
Australia
Date submitted for ethics approval [1] 292440 0
10/02/2015
Approval date [1] 292440 0
16/02/2015
Ethics approval number [1] 292440 0
0020N_2015

Summary
Brief summary
Electromagnetic Millimetre Wave Therapy (EMT), originally developed in Russia, has shown promise in pain relief therapy in several randomised controlled trials conducted in the USA and Europe in the last 15 years. EMT was shown to be effective in reducing painful conditions, including joint pain, headache, postoperative pain, and neuropathic pain.

Aims of this study
In this study, we want to find out:
1. The effect of EMT on pain relief
2. The effect of EMT on pain related quality of life
3. The duration of pain relief by EMT
4. The tolerability of EMT

The proposed study will be a preliminary investigation of the effectiveness of EMT in pain relief. Data will inform the proposal for a larger cohort study.
Patients, presenting with chronic pain and attending the NIIM clinic, will be approached to participate. Pain levels and locations will be variable, in this pilot phase. Consenting patients will be treated with EMT therapy for 15 minutes. Subjective pain levels, and the impact on the quality of life will be assessed at baseline, shortly after EMT treatment, and at regular intervals for three days after the clinical session, using validated pain scales.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55282 0
Dr Karin Ried
Address 55282 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country 55282 0
Australia
Phone 55282 0
+61 3 9912 9545
Fax 55282 0
Email 55282 0
[email protected]
Contact person for public queries
Name 55283 0
Karin Ried
Address 55283 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country 55283 0
Australia
Phone 55283 0
+61 3 9912 9545
Fax 55283 0
Email 55283 0
[email protected]
Contact person for scientific queries
Name 55284 0
Karin Ried
Address 55284 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country 55284 0
Australia
Phone 55284 0
+61 3 9912 9545
Fax 55284 0
Email 55284 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.