Trial Outcomes & Findings for Percutaneous Microelectrolysis on Myofascial Trigger Points Pain. (NCT NCT03636386)
NCT ID: NCT03636386
Last Updated: 2023-04-18
Results Overview
Pain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by participants when performing algometry test at sensitive point of upper trapezius muscle. PPT was valued in four occasions: PPT1 pre (baseline), PPT1 post, PPT 2 (at day 3) and PPT 3 (at day 7). PPT will be evaluated through the BASELINE® pressure algometer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
PPTpre1 (baseline), PPTpost1 (post baseline), PPT2 (Day 3), PPT3 (Day 7), assessed an average of 30 minutes at each session
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
Percutaneous Microelectrolysis Group (MEP)
Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
Control Group (Ultrasound Therapy)
Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Percutaneous Microelectrolysis on Myofascial Trigger Points Pain.
Baseline characteristics by cohort
| Measure |
Percutaneous Microelectrolysis Group (MEP)
n=24 Participants
Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
Ultrasound Therapy
n=24 Participants
Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 1.9 • n=99 Participants
|
22.0 years
STANDARD_DEVIATION 1.6 • n=107 Participants
|
22.3 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Body mass index (BMI)
|
24.5 kg/m2
STANDARD_DEVIATION 3.4 • n=99 Participants
|
22.9 kg/m2
STANDARD_DEVIATION 2.3 • n=107 Participants
|
23.6 kg/m2
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Short trapezius muscle laterality
Right
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Short trapezius muscle laterality
Left
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
SP-AC
|
9.2 centimeters
STANDARD_DEVIATION 1.8 • n=99 Participants
|
8.4 centimeters
STANDARD_DEVIATION 1.7 • n=107 Participants
|
8.7 centimeters
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
PPTpre intervention (PPTpre1)
|
1.4 Kg/cm2
STANDARD_DEVIATION 0.2 • n=99 Participants
|
1.4 Kg/cm2
STANDARD_DEVIATION 0.2 • n=107 Participants
|
1.4 Kg/cm2
STANDARD_DEVIATION 0.2 • n=206 Participants
|
|
PIpre intervention (PIpre1)
|
32.1 mm
STANDARD_DEVIATION 13.6 • n=99 Participants
|
31.4 mm
STANDARD_DEVIATION 15.1 • n=107 Participants
|
32.0 mm
STANDARD_DEVIATION 14.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: PPTpre1 (baseline), PPTpost1 (post baseline), PPT2 (Day 3), PPT3 (Day 7), assessed an average of 30 minutes at each sessionPain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by participants when performing algometry test at sensitive point of upper trapezius muscle. PPT was valued in four occasions: PPT1 pre (baseline), PPT1 post, PPT 2 (at day 3) and PPT 3 (at day 7). PPT will be evaluated through the BASELINE® pressure algometer.
Outcome measures
| Measure |
Percutaneous Microelectrolysis Group (MEP)
n=24 Participants
Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
Control Group (Ultrasound Therapy)
n=24 Participants
Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
|---|---|---|
|
Pain Pressure Threshold (PPT)
PPTdiff2-1
|
0.4 Kg/cm2
Standard Deviation 0.2
|
0.2 Kg/cm2
Standard Deviation 0.2
|
|
Pain Pressure Threshold (PPT)
PPTdiff3-1
|
0.5 Kg/cm2
Standard Deviation 0.4
|
0.3 Kg/cm2
Standard Deviation 0.3
|
|
Pain Pressure Threshold (PPT)
PPTpre1
|
1.4 Kg/cm2
Standard Deviation 0.2
|
1.4 Kg/cm2
Standard Deviation 0.2
|
|
Pain Pressure Threshold (PPT)
PPTpost1
|
1.6 Kg/cm2
Standard Deviation 0.2
|
1.6 Kg/cm2
Standard Deviation 0.2
|
|
Pain Pressure Threshold (PPT)
PPT2
|
1.7 Kg/cm2
Standard Deviation 0.1
|
1.6 Kg/cm2
Standard Deviation 0.2
|
|
Pain Pressure Threshold (PPT)
PPT3
|
1.9 Kg/cm2
Standard Deviation 0.3
|
1.7 Kg/cm2
Standard Deviation 0.2
|
|
Pain Pressure Threshold (PPT)
PPTdiff1-1
|
0.2 Kg/cm2
Standard Deviation 0.2
|
0.2 Kg/cm2
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: PIpre1 (baseline), PIpost1 (post baseline), PI2 (Day 3), PI3 (Day 7), assessed an average of 3 minutes at each sessionMagnitude of pain expressed in millimeters (mm) referred by participants. PI was evaluated through visual analogue scale at moment of performing pressure algometry test in the sensitive point of upper trapezius muscle. PI was assessed with an analogous visual scale where the participant will mark the pain generated by the algometry on a scale of 1 to 100 millimeters. PI was valued in four occasions: PI1 pre (baseline), PI1 post, PI 2 (at day 3) and PI 3 (at day 7).
Outcome measures
| Measure |
Percutaneous Microelectrolysis Group (MEP)
n=24 Participants
Group exposed to direct current application using an acupuncture needle with intensities in microamps (μA) in MTrP of upper trapezius muscle. Acupuncture needle correspond to negative electrode or cathode. This group was also be treated with conventional ultrasound (US) before MEP application. US treatments parameters will include; 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Percutaneous microelectrolysis: 284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
Control Group (Ultrasound Therapy)
n=24 Participants
Group treated with conventional ultrasound (US) on MTrP with 1MHz, 1.5W/cm2, 5cm2 ERA, 100% duty cycle and 15 minutes treatment time.
Ultrasound therapy: Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
|
|---|---|---|
|
Pain Intensity (PI)
PIdiff1-1
|
-7.5 mm
Standard Deviation 8.4
|
-6.6 mm
Standard Deviation 8.6
|
|
Pain Intensity (PI)
PIpre1
|
32.1 mm
Standard Deviation 13.6
|
31.4 mm
Standard Deviation 15.1
|
|
Pain Intensity (PI)
PIpost1
|
24.6 mm
Standard Deviation 12.7
|
24.8 mm
Standard Deviation 15.1
|
|
Pain Intensity (PI)
PI2
|
21.6 mm
Standard Deviation 11.0
|
23.8 mm
Standard Deviation 14.0
|
|
Pain Intensity (PI)
PI3
|
18.1 mm
Standard Deviation 9.9
|
20.0 mm
Standard Deviation 13.2
|
|
Pain Intensity (PI)
PIdiff2-1
|
-10.5 mm
Standard Deviation 11.9
|
-7.6 mm
Standard Deviation 12.1
|
|
Pain Intensity (PI)
PIdiff3-1
|
-14.0 mm
Standard Deviation 12.3
|
-11.5 mm
Standard Deviation 13.1
|
Adverse Events
Percutaneous Microelectrolysis Group (MEP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (Ultrasound Therapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Hernán Andrés de la Barra Ortiz
Universidad Andrés Bello
Phone: +56984706322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place