Parkinsons Disease
Conditions
Keywords
Parkinsons Disease, Fatigue
Brief summary
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.
Interventions
PROCEDUREAcupuncture
Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes
OTHERAcupuncture to treat fatigue in Parkinson disease
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with PD * Patients 40-99 years of age * Patients who have significant fatigue * Patients must be on a stable medication regimen for the treatment of PD
Exclusion criteria
* Patients who have had previous acupuncture within the past six months * Patients who have had deep brain stimulation (DBS) * Patients with dementia, depression, or sleep disorder * Patients who are currently taking medications known to affect fatigue, such as stimulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups | 6 weeks | The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Subjects Receive a Sham Acupuncture. Subjects were randomized in a 1:1 ratio to receive either real or sham acupuncture.
Acupuncture to treat fatigue in Parkinson disease: Subjects will be randomized in a 1:1 ratio to receive sham acupuncture. | 47 |
| Randomized Subjects Receive Real Acupuncture. Subjects were randomized in a 1:1 ratio to receive either real or sham acupuncture.
Acupuncture: Subjects will be randomized in a 1:1 ratio to receive real acupuncture.
Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes | 47 |
| Total | 94 |
Baseline characteristics
| Characteristic | Total | Randomized Subjects Receive Real Acupuncture. | Randomized Subjects Receive a Sham Acupuncture. |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 11.7 | 64.4 years STANDARD_DEVIATION 10.3 | 63.0 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 94 Participants | 47 Participants | 47 Participants |
| Modified Fatigue Impact Scale Total | 49.4 units on a scale STANDARD_DEVIATION 11.7 | 48.7 units on a scale STANDARD_DEVIATION 10.5 | 50.0 units on a scale STANDARD_DEVIATION 12.9 |
| 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 | 0 Participants | 0 Participants | 0 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 | 94 Participants | 47 Participants | 47 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 94 count of participants | 47 count of participants | 47 count of participants |
| Sex: Female, Male Female | 35 Participants | 17 Participants | 18 Participants |
| Sex: Female, Male Male | 59 Participants | 30 Participants | 29 Participants |
| Unified Parkinson Disease Rating Scale (UPDRS)-Motor subscale | 24.2 units on a scale STANDARD_DEVIATION 10 | 21.6 units on a scale STANDARD_DEVIATION 7.8 | 26.7 units on a scale STANDARD_DEVIATION 11.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 1 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Subjects Receive a Sham Acupuncture. | Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups | -13.2 units on a scale | Standard Deviation 13.8 |
| Randomized Subjects Receive Real Acupuncture. | Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups | -16.0 units on a scale | Standard Deviation 15.1 |