Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000080628
Ethics application status
Approved
Date submitted
30/11/2022
Date registered
25/01/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
25/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy and safety of Bioelectric Meridian Therapy on pain: a randomised, sham intervention-controlled study
Scientific title
The efficacy and safety of Bioelectric Meridian Therapy on pain in healthy volunteers: a randomised, sham intervention-controlled study
Secondary ID [1] 308519 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 328345 0
Condition category
Condition code
Anaesthesiology 325383 325383 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bioelectric Meridian Therapy (BMT) is a non-invasive, drug-free intervention for pain management, used clinically to manage pain, decrease inflammation, and improve function with only anecdotal evidence. BMT is delivered using the Bioelectric Meridian Massage Australia (ABMMA) Pro device which is very similar to well-established transcutaneous electrical stimulation (TENS), yet different. BMT is a combination of gentle massage by a therapist (on the back, legs, hips and thighs) and an electrical stimulation delivered via ABMMA Pro whereas TENS does not have a massage component. TENS specifically targets cutaneous nerves, whereas BMT stimulates acupuncture points, meridians and Ashi points. Cutaneous nerves may be stimulated, but they are not the target. TENS is delivered directly to patients through surface electrodes, whereas BMT delivers a small electrical signal to the patient body through the therapist’s hands. In BMT, the electrical current follows the movement of the measure’s hands so that the electrical current is delivered to a large area of the body whereas electrodes in TENS is often placed at a specific area without continuous changes in the site of stimulation.
In this study BMT will be delivered for 45 minutes by a qualified healthcare practitioner (with more than 15 years of experience in pain management) in the Pain Analysis Laboratory at RMIT University. The intervention will be delivered through a cross-over design with one treatment session and one sham session in a randomised order and a washout period of one week. A research assistant will be monitoring and organising the session schedules with the participants.
During the 45 minutes of intervention, the participant will first be in the prone position and the BMT pads will be placed on the lower abdomen (anterior sacroiliac spine area). The BMT gentle massage will be delivered on the back, and upper legs. Then, the participant will be asked to turn to in supine position, the BMT pads will be placed on the lower back (posterior sacroiliac joint area) and the gentle BMT massage will be delivered on the thigh. The parameters for the ABMMA Pro are high frequency and intensity level 8-12. The guiding principle is the intensity level needing to be comfortable to the individual. Intensity 12 is recommended if it is possible to reach.
Intervention code [1] 324960 0
Treatment: Devices
Comparator / control treatment
Each participant will act as their own control through a cross-over design. They will be randomised to receive either the real followed by the sham treatment or the sham followed by the real treatment. There will be a one-week washout period in between the two sessions.
The sham intervention will follow the same procedure (45 minutes with gentle massage by the same therapist and similar locations for the BMT pads) as the real treatment. However, the sham ABMMA Pro will be used. The sham ABMMA Pro is similar in appearance to the ABMMA Pro and also produce similar audio outputs, but there will be no electrical stimulation delivered by the sham ABMMA pro.
Control group
Placebo

Outcomes
Primary outcome [1] 333238 0
Pressure pain threshold (PPT) using a digital algometer on the back
Timepoint [1] 333238 0
baseline and 20minutes post-treatment
Primary outcome [2] 333528 0
Pressure pain threshold (PPT) using a digital algometer on the calves
Timepoint [2] 333528 0
baseline and 20 minutes post-treatment
Primary outcome [3] 333529 0
Pressure pain threshold (PPT) using a digital algometer on the wrists
Timepoint [3] 333529 0
baseline and 20 post-treatment
Secondary outcome [1] 416303 0
Suprathreshold pressure stimulus (SUPRA) using a digital algometer on the lower back.
Timepoint [1] 416303 0
baseline and 20minutes post-treatment
Secondary outcome [2] 416304 0
Skin temperature on the lower back using an infrared camera
Timepoint [2] 416304 0
before and after treatment
Secondary outcome [3] 417425 0
Suprathreshold pressure stimulus (SUPRA) using a digital algometer on the calves.
Timepoint [3] 417425 0
before and 20 minutes post-treatment
Secondary outcome [4] 417426 0
Suprathreshold pressure stimulus (SUPRA) using a digital algometer on the wrists
Timepoint [4] 417426 0
before and 20 minutes post-treatment
Secondary outcome [5] 417427 0
Adverse events associated to the real/sham BMT and pain tests will be recorded by the BMT therapist. The therapist will ask the participants to self-report any adverse events associated to the real/sham BMT and pain tests. For example participants may experience a small amount of discomfort due to pain from measuring their pressure pain thresholds and suprathreshold sensitivity. Another example is after a BMT session the participant may experience tiredness, sleepiness, headache and / or muscle soreness at the site of treatment.
Timepoint [5] 417427 0
immediately after the session and within the week following the session
Secondary outcome [6] 417751 0
Skin temperature on the legs using an infrared camera
Timepoint [6] 417751 0
before and after treatment
Secondary outcome [7] 417752 0
Skin temperature on the wrists using an infrared camera
Timepoint [7] 417752 0
before and after treatment

Eligibility
Key inclusion criteria
-aged between 18 and 50 years,
-without any current pain or ongoing pain or other major health issues;
-not taking any analgesics or anti-inflammatory medications;
-not wearing a pacemaker or having any metal implant in the areas of BMT therapy,
-fluent in English,
-without Bioelectrical Massage Therapy experience in the last three years
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Pregnancy or intent to become pregnant
-Regular use of analgesics
-Heavy user of alcohol
-Previous neurological or cognitive illnesses
-Injuries
-having had massage or acupuncture treatment in the last two weeks.

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)
Before the first session, each participant will be invited to draw a sealed envelope out of a stack of 30, each containing a number corresponding to a random number sequence generated using Excel by the trial therapist who delivers BMT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence generated using Excel by the trial therapist who delivers BMT.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Paired tests and Chi-square tests will be used to analyze the baseline data. Two-way (site, BMT session) with two repeated measure (site and BMT) analysis of variance (ANOVA) will be used to assess the main effect of mode (real and sham BMT) and site and their interactions in the percentage changes of PPTs and SUPRA. Appropriate post-hoc analyses, such as one-way ANOVA or paired t tests, will be used when necessary. Data will be presented as mean and standard deviation. A p < 0.05 will be statistically significant. The Holm-Bonferroni correction will be used for multiple comparisons. A p-value that is smaller than the Holm-Bonferroni-adjusted significance is considered statistically significant. Any adverse event that occurs immediately after the treatment will be recorded.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
3/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39074 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 312758 0
Commercial sector/Industry
Name [1] 312758 0
ABMMA
Country [1] 312758 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
PO Box 71, Bundoora Victoria, 3083, Australia
Country
Australia
Secondary sponsor category [1] 314389 0
None
Name [1] 314389 0
none
Address [1] 314389 0
Country [1] 314389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312060 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 312060 0
124 La Trobe Street, Melbourne VIC 3000
Ethics committee country [1] 312060 0
Australia
Date submitted for ethics approval [1] 312060 0
30/11/2022
Approval date [1] 312060 0
25/01/2023
Ethics approval number [1] 312060 0
25932

Summary
Brief summary
Bioelectric Meridian Therapy (BMT) is a non-invasive, drug-free intervention for pain management. It has been used clinically to manage pain, decrease inflammation and improve function with only anecdotal evidence. BMT is a combination of gentle massage by a therapist and an electrical stimulation delivered via an innovative device, called ABMMA Pro. ABMMA Pro is very similar to well-established transcutaneous electrical stimulation (TENS), yet different. There is ample anecdotal evidence supporting the analgesic effect of BMT, but there is insufficient research data on the efficacy and safety of BMT. In this randomised, sham-intervention controlled study with a cross-over design, we aim to examine (1) if BMT induces analgesia, by assessing changes in pain threshold and if BMT is safe to use; 2) if BMT induces local and / or distal analgesia effect. Thirty healthy individuals (free from ongoing pain) will be recruited to participate in the study. Each participant will receive the real and sham BMT in a random order, with one week in between the two sessions. Their pressure pain thresholds (PPT) will be measured before and after the intervention using an algometer. PPT will be measured on the calves, low back and wrists. Confounding measures that will be measured are quality of life, severity of anxiety and expectancy. One researcher will measure PPT and experimental pain, and another will deliver the intervention. The participants and the researcher measuring the PPT will be blinded to the intervention that the participants receive. Any adverse event that occurs immediately after the treatment will be recorded. The results of this study will provide essential evidence of the efficacy and safety of BMT on moderating pain in healthy volunteers. If BMT is found to be superior to sham intervention, future studies should assess its efficacy among patients with chronic pain. BMT could be a valid alternative to pain medications for many people who cannot tolerate analgesics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123318 0
A/Prof Zhen Zheng
Address 123318 0
PO Box 71, Bundoora Victoria, 3083, Australia
Country 123318 0
Australia
Phone 123318 0
+61 3 9925 7167
Fax 123318 0
Email 123318 0
zhen.zheng@rmit.edu.au
Contact person for public queries
Name 123319 0
A/Prof Zhen Zheng
Address 123319 0
PO Box 71, Bundoora Victoria, 3083, Australia
Country 123319 0
Australia
Phone 123319 0
+61 3 9925 7167
Fax 123319 0
Email 123319 0
zhen.zheng@rmit.edu.au
Contact person for scientific queries
Name 123320 0
A/Prof Zhen Zheng
Address 123320 0
PO Box 71, Bundoora Victoria, 3083, Australia
Country 123320 0
Australia
Phone 123320 0
+61 3 9925 7167
Fax 123320 0
Email 123320 0
zhen.zheng@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group data will be shared on request.


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.