Trial Outcomes & Findings for Acupuncture in Myasthenia Gravis (AcuMG) (NCT NCT05230082)
NCT ID: NCT05230082
Last Updated: 2025-09-18
Results Overview
A brief 15-item disease specific questionnaire. Myasthenia gravis-quality of life 15 (MG-QOL15). A higher score indicates a lower quality of life.\[range: 0-30\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
pre-acupuncture treatment and post-acupuncture treatment
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
Immediate Start
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
Period 1: Acupuncture - Weeks 1-12 Period 2: No Acupuncture - Weeks 13-27
|
Delayed Start
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
Period 1: No Acupuncture - Weeks 1-12 Period 2: Acupuncture - Weeks 13-24
|
|---|---|---|
|
Period 1: Weeks 1-12
STARTED
|
10
|
14
|
|
Period 1: Weeks 1-12
COMPLETED
|
6
|
13
|
|
Period 1: Weeks 1-12
NOT COMPLETED
|
4
|
1
|
|
Period 2: Weeks 13-24
STARTED
|
6
|
13
|
|
Period 2: Weeks 13-24
COMPLETED
|
6
|
11
|
|
Period 2: Weeks 13-24
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture in Myasthenia Gravis (AcuMG)
Baseline characteristics by cohort
| Measure |
Immediate Start
n=10 Participants
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start
n=14 Participants
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 12 • n=5 Participants
|
59 years
STANDARD_DEVIATION 13 • n=7 Participants
|
62 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Time since MG Diagnosis
|
6 years
STANDARD_DEVIATION 8 • n=5 Participants
|
10 years
STANDARD_DEVIATION 11 • n=7 Participants
|
8 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Diagnosis Classification
Yang deficiency
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diagnosis Classification
Yin deficiency
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Diagnosis Classification
Stagnation pronounced
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diagnosis Classification
Base treatment
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diagnosis Classification
Withdrawn before classification
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-acupuncture treatment and post-acupuncture treatmentPopulation: Participants withdrew prior to the post-treatment measurement.
A brief 15-item disease specific questionnaire. Myasthenia gravis-quality of life 15 (MG-QOL15). A higher score indicates a lower quality of life.\[range: 0-30\]
Outcome measures
| Measure |
Immediate Start
n=10 Participants
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start
n=14 Participants
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
To Determine the Effect of Acupuncture on Quality of Life in Patients With MG
pre-treatment
|
10.8 score on a scale
Standard Deviation 6.7
|
9.4 score on a scale
Standard Deviation 7.4
|
|
To Determine the Effect of Acupuncture on Quality of Life in Patients With MG
post-treatment
|
3.6 score on a scale
Standard Deviation 2.0
|
8.3 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: pre-acupuncture treatment and post-acupuncture treatmentPopulation: Participants withdrew prior to the post-treatment measurement.
A brief 8-item disease specific questionnaire. Myasthenia gravis-activities of daily living (MG-ADL). A higher score indicates activities of daily living are more difficult.\[range: 0-24\]
Outcome measures
| Measure |
Immediate Start
n=10 Participants
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start
n=14 Participants
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG
Pre-treatment
|
5.0 score on a scale
Standard Deviation 3.1
|
3.6 score on a scale
Standard Deviation 3.0
|
|
To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG
Post-treatment
|
2.3 score on a scale
Standard Deviation 1.6
|
3.5 score on a scale
Standard Deviation 2.4
|
Adverse Events
Immediate Start - Period 1 - Acupuncture Treatment
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Immediate Start - Period 2 - No Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Delayed Start - Period 1 - No Intervention
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Delayed Start - Period 2 - Acupuncture Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Start - Period 1 - Acupuncture Treatment
n=10 participants at risk
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Immediate Start - Period 2 - No Intervention
n=10 participants at risk
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start - Period 1 - No Intervention
n=14 participants at risk
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start - Period 2 - Acupuncture Treatment
n=14 participants at risk
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastroparesis
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
Other adverse events
| Measure |
Immediate Start - Period 1 - Acupuncture Treatment
n=10 participants at risk
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Immediate Start - Period 2 - No Intervention
n=10 participants at risk
Patients will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start - Period 1 - No Intervention
n=14 participants at risk
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Delayed Start - Period 2 - Acupuncture Treatment
n=14 participants at risk
Patients will act as control group for the first 12 weeks then will receive acupuncture treatment two times per week for 12 weeks.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
20.0%
2/10 • Number of events 7 • 8 months
|
10.0%
1/10 • Number of events 1 • 8 months
|
7.1%
1/14 • Number of events 2 • 8 months
|
0.00%
0/14 • 8 months
|
|
Injury, poisoning and procedural complications
Needling pain/bruising
|
30.0%
3/10 • Number of events 5 • 8 months
|
0.00%
0/10 • 8 months
|
21.4%
3/14 • Number of events 4 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 4 • 8 months
|
0.00%
0/10 • 8 months
|
14.3%
2/14 • Number of events 2 • 8 months
|
0.00%
0/14 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus issues
|
40.0%
4/10 • Number of events 6 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • 8 months
|
0.00%
0/10 • 8 months
|
14.3%
2/14 • Number of events 2 • 8 months
|
0.00%
0/14 • 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 2 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Sleep disturbances
|
0.00%
0/10 • 8 months
|
0.00%
0/10 • 8 months
|
14.3%
2/14 • Number of events 2 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
COVID-19
|
0.00%
0/10 • 8 months
|
0.00%
0/10 • 8 months
|
14.3%
2/14 • Number of events 2 • 8 months
|
0.00%
0/14 • 8 months
|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
|
Eye disorders
Eye Tearing
|
0.00%
0/10 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Vaccine Reactions
|
0.00%
0/10 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Eye Ptosis
|
0.00%
0/10 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Hip Vibration Sensation
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/10 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Restless Leg
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Phantom Sensation
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Numbness
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
Blood and lymphatic system disorders
Eye Bruising
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
0.00%
0/14 • 8 months
|
0.00%
0/14 • 8 months
|
|
General disorders
Pneumonia and Flu
|
10.0%
1/10 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
7.1%
1/14 • Number of events 1 • 8 months
|
0.00%
0/14 • 8 months
|
Additional Information
Amanda Herrmann, PhD
HealthPartners Institute Neuroscience Research Center
Phone: 651-495-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place