Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Neck Pain in Adults

• ClinicalTrials.gov Identifier: NCT05889039
• Recruitment Status: Completed
• First Posted: June 5, 2023
• Results First Posted: November 15, 2023
• Last Update Posted: November 15, 2023
• Sponsor: Lake Erie College of Osteopathic Medicine
• Information provided by (Responsible Party): Santiago Lorenzo, PhD, Lake Erie College of Osteopathic Medicine

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Neck Pain
• Interventions: Device: BEMER; Procedure: OMT; Procedure: Sham OMT + Sham BEMER
• Enrollment: 44

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
Arm/Group Description	Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated. Sham OMT + Sham BEMER: Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.	Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. OMT was performed prior to BEMER therapy for those in the combined group. Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
Period Title: Overall Study
Started	12	12	10	10
Completed	8	10	10	10
Not Completed	4	2	0	0
Reason Not Completed
error in completing survey	0	2	0	0
Lost to Follow-up	4	0	0	0

Baseline Characteristics

Arm/Group Title		OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER	Total
Arm/Group Description		Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated. Sham OMT + Sham BEMER: Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.	Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. OMT was performed prior to BEMER therapy for those in the combined group. Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Total of all reporting groups
Overall Number of Baseline Participants		12	12	10	10	44
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	10 participants	10 participants	44 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	12 100.0%	12 100.0%	10 100.0%	10 100.0%	44 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12 participants	12 participants	10 participants	10 participants	44 participants
		25.3 (1.6)	24.6 (1.6)	25.9 (2.5)	24.8 (1.8)	25.2 (1.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	10 participants	10 participants	44 participants
	Female	8 66.7%	9 75.0%	7 70.0%	8 80.0%	32 72.7%
	Male	4 33.3%	3 25.0%	3 30.0%	2 20.0%	12 27.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	10 participants	10 participants	44 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	12 100.0%	12 100.0%	10 100.0%	10 100.0%	44 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	12 participants	12 participants	10 participants	10 participants	44 participants
		12	12	10	10	44
Visual Analog Scale [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	12 participants	12 participants	10 participants	10 participants	44 participants
		20.3 (20.2)	13.2 (14.0)	16.5 (13.8)	32.9 (33.4)	20.7 (20.4)
		[1] Measure Description: Scale range (0-100) to determine level of pain (0:no pain, 100: the most pain ever experienced)

Outcome Measures

1. Primary Outcome

Title	Neck Pain Rating Neck Disability Index (NDI)
Description	Assessed by questionnaire rating, compared with pre-intervention rating Neck Disability Index (NDI). Score ranges 0-50. Minimum score=0 (no activity limitation), Maximum score=50 (complete activity limitation). Lower scores is better as it reflect lower activity limitation
Time Frame	Within 1 week of completion of 3-week intervention period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
Arm/Group Description:	Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated. Sham OMT + Sham BEMER: Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.	Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. OMT was performed prior to BEMER therapy for those in the combined group. Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
Overall Number of Participants Analyzed	8	10	10	10
Mean (Standard Deviation); Unit of Measure: units on a scale
	13 (7.6)	7.4 (8.5)	12.2 (10.9)	11.2 (7.6)

2. Primary Outcome

Title	Neck Pain Rating Visual Analog Scale (VAS)
Description	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
Time Frame	Within 1 week of completion of 3-week intervention period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
Arm/Group Description:	Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated. Sham OMT + Sham BEMER: Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.	Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. OMT was performed prior to BEMER therapy for those in the combined group. Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
Overall Number of Participants Analyzed	8	10	10	10
Mean (Standard Deviation); Unit of Measure: units on a scale
	15.5 (13.4)	7.1 (10.8)	16 (14.2)	11.5 (8.4)

3. Primary Outcome

Title	Quality of Life Rating Short Form 12-item (SF-12) Health Survey
Description	Assessed 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
Time Frame	Within 1 week of completion of 3-week intervention period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
Arm/Group Description:	Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated. Sham OMT + Sham BEMER: Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.	Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. OMT was performed prior to BEMER therapy for those in the combined group. Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
Overall Number of Participants Analyzed	8	10	10	10
Mean (Standard Deviation); Unit of Measure: units on a scale
	47.5 (11.1)	45.4 (9)	43.7 (14.7)	45.6 (13)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
Arm/Group Description	Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated. Sham OMT + Sham BEMER: Participants in the CONTROL group received light touch and BEMER sham treatments. Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.	Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.	Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG). The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3. The B.Pad (BEMER International AG) was placed under their cervical region. B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3. These settings were selected based on the manufacturer's recommendations. OMT was performed prior to BEMER therapy for those in the combined group. Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found. BEMER: Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain. OMT: Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
All-Cause Mortality
	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/12 (0.00%)	0/12 (0.00%)	0/10 (0.00%)	0/10 (0.00%)
Serious Adverse Events
	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/12 (0.00%)	0/12 (0.00%)	0/10 (0.00%)	0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	OMT + BEMER PLACEBO	Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy	OMT (Osteopathic Manipulative Treatment)	OMT+BEMER
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/12 (0.00%)	0/12 (0.00%)	0/10 (0.00%)	0/10 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Santiago Lorenzo
• Organization: LECOM
• Phone: 941-782-5974
• EMail: slorenzo@lecom.edu

• Responsible Party: Santiago Lorenzo, PhD, Lake Erie College of Osteopathic Medicine
• ClinicalTrials.gov Identifier: NCT05889039
• Other Study ID Numbers: 26-164
• First Submitted: May 10, 2023
• First Posted: June 5, 2023
• Results First Submitted: October 2, 2023
• Results First Posted: November 15, 2023
• Last Update Posted: November 15, 2023