Trial Outcomes & Findings for Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Low Back Pain in Adults. (NCT NCT04704375)
NCT ID: NCT04704375
Last Updated: 2023-11-18
Results Overview
Assessed by questionnaire rating, compared with pre-intervention rating Visual Analog Scale (VAS). Score ranges 0-100. Minimum score=0 (no pain), Maximum score=100 (worst pain ever felt). Lower scores is better as it reflect lower pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Within 1 week of completion of 3-week intervention period
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
BEMER
Subjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
|
OMT (Osteopathic Manipulative Treatment)
Each subject in the OMT group received treatment 3 times per week for a period of 3 weeks.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
BEMER + OMT
Each subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
Control
Finally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.
Light touch: Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Low Back Pain in Adults.
Baseline characteristics by cohort
| Measure |
BEMER
n=10 Participants
Subjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
|
OMT (Osteopathic Manipulative Treatment)
n=10 Participants
Each subject in the OMT group received treatment 3 times per week for a period of 3 weeks.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
BEMER + OMT
n=10 Participants
Each subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
Control
n=10 Participants
Finally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.
Light touch: Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Visual Analog Scale
|
44.5 units on a scale
STANDARD_DEVIATION 20.6 • n=5 Participants
|
32.1 units on a scale
STANDARD_DEVIATION 25.2 • n=7 Participants
|
38.2 units on a scale
STANDARD_DEVIATION 26.8 • n=5 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 26.0 • n=4 Participants
|
37.2 units on a scale
STANDARD_DEVIATION 24.7 • n=21 Participants
|
PRIMARY outcome
Timeframe: Within 1 week of completion of 3-week intervention periodAssessed by questionnaire rating, compared with pre-intervention rating Visual Analog Scale (VAS). Score ranges 0-100. Minimum score=0 (no pain), Maximum score=100 (worst pain ever felt). Lower scores is better as it reflect lower pain
Outcome measures
| Measure |
BEMER
n=10 Participants
Subjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
|
OMT (Osteopathic Manipulative Treatment)
n=10 Participants
Each subject in the OMT group received treatment 3 times per week for a period of 3 weeks.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
BEMER + OMT
n=10 Participants
Each subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
Control
n=10 Participants
Finally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.
Light touch: Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.
|
|---|---|---|---|---|
|
Low Back Pain Rating Visual Analog Scale
|
44.5 units on a scale
Standard Deviation 20.6
|
32.1 units on a scale
Standard Deviation 25.2
|
38.2 units on a scale
Standard Deviation 26.8
|
34.1 units on a scale
Standard Deviation 26
|
PRIMARY outcome
Timeframe: Within 1 week of completion of 3-week intervention periodAssessed by questionnaire rating, compared with pre-intervention rating Oswestry low back pain questionnaire: Scores range 0-50. 0-4 indicating no disability; 5-14 indicating minimal disability; 15-24 moderate disability; 25-34 severe disability; 35-50 complete disability. Lower scores is better as it reflect lower pain
Outcome measures
| Measure |
BEMER
n=10 Participants
Subjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
|
OMT (Osteopathic Manipulative Treatment)
n=10 Participants
Each subject in the OMT group received treatment 3 times per week for a period of 3 weeks.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
BEMER + OMT
n=10 Participants
Each subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
Control
n=10 Participants
Finally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.
Light touch: Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.
|
|---|---|---|---|---|
|
Low Back Pain Rating Oswestry Low Back Pain Questionnaire
|
14.8 units on a scale
Standard Deviation 10.8
|
14.4 units on a scale
Standard Deviation 12.1
|
11.2 units on a scale
Standard Deviation 10.8
|
10.8 units on a scale
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: Within 1 week of completion of 3-week intervention periodAssessed by questionnaire rating, compared with pre-intervention rating Short form 12-item (SF-12) health survey. Scores range 0%-100%. Score of 0 (minimum) no pain. Score of 100 (maximum) lot of pain. Lower scores is better as it reflect lower pain
Outcome measures
| Measure |
BEMER
n=10 Participants
Subjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
|
OMT (Osteopathic Manipulative Treatment)
n=10 Participants
Each subject in the OMT group received treatment 3 times per week for a period of 3 weeks.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
BEMER + OMT
n=10 Participants
Each subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.
Bio Electro-Magnetic Regulation (BEMER) Therapy: BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
OMT (osteopathic manipulative treatment): i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
|
Control
n=10 Participants
Finally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.
Light touch: Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.
|
|---|---|---|---|---|
|
Quality of Life Rating Short Form 12-item (SF-12) Health Survey
|
46.8 units on a scale
Standard Deviation 6.5
|
44.9 units on a scale
Standard Deviation 8.9
|
46.0 units on a scale
Standard Deviation 11.4
|
48.6 units on a scale
Standard Deviation 6.9
|
Adverse Events
BEMER
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OMT (Osteopathic Manipulative Treatment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BEMER + OMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place