Myasthenia Gravis
Conditions
Brief summary
The purpose of the study is to determine the effect acupuncture treatment on individuals with a diagnosis of Myasthenia Gravis (MG). A total of 20 people with MG will be enrolled in this study to receive acupuncture treatment 2 times a week for 12 weeks. Participants will be randomized into two groups: 1) Immediate start and 2) Delayed start (12 weeks). The delayed start group will act as a control group for the first 12 weeks, but then receive acupuncture treatment for 12 weeks. It is hypothesized that patients with MG who receive acupuncture treatment will have improved quality of life and activities of daily living compared to no treatment.
Interventions
OTHERAcupuncture
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.
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ability to provide and provision of signed and dated informed consent form * Age 18-80 * Diagnosis of MG
Exclusion criteria
* Non-English speaking * Participation in acupuncture treatment outside of the study, while enrolled * History of any other serious neurological, psychiatric, chronic pain disorders, or seizures * History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture * History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device * Recent or active substance use disorder * Women who are currently pregnant, lactating, or planning to become pregnant during the study * Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators) * Active participation or past participation ≤3 months in any other interventional study. * Unwilling to participate in all study related activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effect of Acupuncture on Quality of Life in Patients With MG | pre-acupuncture treatment and post-acupuncture treatment | A brief 15-item disease specific questionnaire. Myasthenia gravis-quality of life 15 (MG-QOL15). A higher score indicates a lower quality of life.\[range: 0-30\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG | pre-acupuncture treatment and post-acupuncture treatment | 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.\[range: 0-24\] |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 14 |
| Total | 24 |
Baseline characteristics
| Characteristic | Immediate Start | Total | Delayed Start |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 12 | 62 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 13 |
| Diagnosis Classification Base treatment | 1 Participants | 1 Participants | 0 Participants |
| Diagnosis Classification Stagnation pronounced | 1 Participants | 4 Participants | 3 Participants |
| Diagnosis Classification Withdrawn before classification | 2 Participants | 4 Participants | 2 Participants |
| Diagnosis Classification Yang deficiency | 4 Participants | 9 Participants | 5 Participants |
| Diagnosis Classification Yin deficiency | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 24 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 21 Participants | 13 Participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
| Time since MG Diagnosis | 6 years STANDARD_DEVIATION 8 | 8 years STANDARD_DEVIATION 9 | 10 years STANDARD_DEVIATION 11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 5 / 10 | 1 / 10 | 8 / 14 | 0 / 14 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 | 0 / 14 | 0 / 14 |
Outcome results
Primary
To Determine the Effect of Acupuncture on Quality of Life in Patients With MG
A brief 15-item disease specific questionnaire. Myasthenia gravis-quality of life 15 (MG-QOL15). A higher score indicates a lower quality of life.\[range: 0-30\]
Time frame: pre-acupuncture treatment and post-acupuncture treatment
Population: Participants withdrew prior to the post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Start | 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 |
| Immediate Start | 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 |
| Delayed Start | To Determine the Effect of Acupuncture on Quality of Life in Patients With MG | pre-treatment | 9.4 score on a scale | Standard Deviation 7.4 |
| Delayed Start | To Determine the Effect of Acupuncture on Quality of Life in Patients With MG | post-treatment | 8.3 score on a scale | Standard Deviation 7 |
Secondary
To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG
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.\[range: 0-24\]
Time frame: pre-acupuncture treatment and post-acupuncture treatment
Population: Participants withdrew prior to the post-treatment measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Start | 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 |
| Immediate Start | 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 |
| Delayed Start | To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG | Pre-treatment | 3.6 score on a scale | Standard Deviation 3 |
| Delayed Start | To Determine the Effect of Acupuncture on Activities of Daily Living in Patients With MG | Post-treatment | 3.5 score on a scale | Standard Deviation 2.4 |