Trial Outcomes & Findings for Acupuncture for Fatigue in Parkinson's Disease (NCT NCT01360229)
NCT ID: NCT01360229
Last Updated: 2019-08-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-08-12
Participant Flow
Participant milestones
| Measure |
Randomized Subjects Receive a Sham Acupuncture.
Subjects will be 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.
|
Randomized Subjects Receive Real Acupuncture.
Subjects will be 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
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Fatigue in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Randomized Subjects Receive a Sham Acupuncture.
n=47 Participants
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.
|
Randomized Subjects Receive Real Acupuncture.
n=47 Participants
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
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 count of participants
n=5 Participants
|
47 count of participants
n=7 Participants
|
94 count of participants
n=5 Participants
|
|
Modified Fatigue Impact Scale Total
|
50.0 units on a scale
STANDARD_DEVIATION 12.9 • n=5 Participants
|
48.7 units on a scale
STANDARD_DEVIATION 10.5 • n=7 Participants
|
49.4 units on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Unified Parkinson Disease Rating Scale (UPDRS)-Motor subscale
|
26.7 units on a scale
STANDARD_DEVIATION 11.1 • n=5 Participants
|
21.6 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
24.2 units on a scale
STANDARD_DEVIATION 10.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
Randomized Subjects Receive a Sham Acupuncture.
n=47 Participants
Subjects will be 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.
|
Randomized Subjects Receive Real Acupuncture.
n=47 Participants
Subjects will be 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
|
|---|---|---|
|
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
|
-13.2 units on a scale
Standard Deviation 13.8
|
-16.0 units on a scale
Standard Deviation 15.1
|
Adverse Events
Randomized Subjects Receive a Sham Acupuncture.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Randomized Subjects Receive Real Acupuncture.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Randomized Subjects Receive a Sham Acupuncture.
n=47 participants at risk
Subjects will be 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.
|
Randomized Subjects Receive Real Acupuncture.
n=47 participants at risk
Subjects will be 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
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
2.1%
1/47 • Number of events 1 • 12 weeks
|
0.00%
0/47 • 12 weeks
|
Additional Information
Dr. Benzi Kluger
University of Colorado School of Medicine
Phone: 3037242194
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place