None listed
Conditions
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.
Interventions
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
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.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed