Trial Outcomes & Findings for Acupuncture for Plantar Fasciosis in the Primary Care Setting (NCT NCT03246087)
NCT ID: NCT03246087
Last Updated: 2024-03-08
Results Overview
Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
90 days
Results posted on
2024-03-08
Participant Flow
94 total subjects. 78 total subjects analyzed. 39 from the initial placebo group were allowed to crossover once their placebo study role was completed.
Participant milestones
| Measure |
Acupuncture
Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
Standard of Care
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Standard of care: standard of care home exercise program
|
Crossover
At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
|---|---|---|---|
|
Randomized
STARTED
|
47
|
47
|
0
|
|
Randomized
COMPLETED
|
39
|
39
|
0
|
|
Randomized
NOT COMPLETED
|
8
|
8
|
0
|
|
Crossover to Acupuncture
STARTED
|
0
|
0
|
39
|
|
Crossover to Acupuncture
COMPLETED
|
0
|
0
|
30
|
|
Crossover to Acupuncture
NOT COMPLETED
|
0
|
0
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Plantar Fasciosis in the Primary Care Setting
Baseline characteristics by cohort
| Measure |
Acupuncture
n=47 Participants
Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
Standard of Care
n=47 Participants
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Standard of care: standard of care home exercise program
|
Crossover
At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
age
|
41 years
STANDARD_DEVIATION 12 • n=5 Participants
|
45 years
STANDARD_DEVIATION 12 • n=7 Participants
|
—
|
43 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
—
|
94 participants
n=4 Participants
|
|
foot injury history
foot injury history-yes
|
36 participants
n=5 Participants
|
32 participants
n=7 Participants
|
—
|
68 participants
n=4 Participants
|
|
foot injury history
foot injury history-no
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
—
|
26 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Crossover pulls from the standard of care group. There are not 30 additional subjects, merely 30 subjects pulled from standard of care to crossover to acupuncture group.
Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain.
Outcome measures
| Measure |
Acupuncture
n=39 Participants
Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
Standard of Care
n=39 Participants
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Standard of care: standard of care home exercise program
|
Crossover
n=30 Participants
At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
|---|---|---|---|
|
NPRS-11
week 0
|
3.8 score on a scale
Standard Deviation 2.4
|
4.3 score on a scale
Standard Deviation 2.8
|
3.7 score on a scale
Standard Deviation 2.7
|
|
NPRS-11
week 2
|
3.1 score on a scale
Standard Deviation 2.3
|
3.7 score on a scale
Standard Deviation 2.8
|
3.0 score on a scale
Standard Deviation 2.6
|
|
NPRS-11
week 4
|
2.6 score on a scale
Standard Deviation 2.1
|
3.3 score on a scale
Standard Deviation 2.5
|
2.1 score on a scale
Standard Deviation 2.0
|
|
NPRS-11
week 6
|
2.5 score on a scale
Standard Deviation 2.2
|
3.0 score on a scale
Standard Deviation 2.2
|
2.6 score on a scale
Standard Deviation 2.2
|
|
NPRS-11
week 12
|
2.4 score on a scale
Standard Deviation 2.2
|
3.4 score on a scale
Standard Deviation 2.8
|
2.6 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Crossover pulls from the standard of care group. There are not 30 additional subjects, merely 30 subjects pulled from standard of care to crossover to acupuncture group.
Revised Foot Function Index Short Form. FFI-R measures the impact of foot pathology on function for 5 subscales of: pain (7 questions), stiffness (7 questions), difficulty (11 questions), activity limitation (3 questions), social issues (6 questions). Each question ranges from 1 (no pain/no stiffness/no difficulty/none of the time) to 4 (severe pain/stiffness/difficulty/all of the time). Subscale scores are added up to a total cumulative score. Minimum total score (least pain/stiffness/difficulty) is 34. Maximum total score (most pain/stiffness/difficulty) is 136.
Outcome measures
| Measure |
Acupuncture
n=39 Participants
Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
Standard of Care
n=39 Participants
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Standard of care: standard of care home exercise program
|
Crossover
n=39 Participants
At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
|---|---|---|---|
|
FFI-R
week 0
|
73 score on a scale
Standard Deviation 14
|
70 score on a scale
Standard Deviation 22
|
63 score on a scale
Standard Deviation 17
|
|
FFI-R
week 2
|
61 score on a scale
Standard Deviation 16
|
64 score on a scale
Standard Deviation 23
|
60 score on a scale
Standard Deviation 22
|
|
FFI-R
week 4
|
56 score on a scale
Standard Deviation 16
|
60 score on a scale
Standard Deviation 21
|
55 score on a scale
Standard Deviation 22
|
|
FFI-R
week 6
|
56 score on a scale
Standard Deviation 18
|
58 score on a scale
Standard Deviation 21
|
58 score on a scale
Standard Deviation 23
|
|
FFI-R
week 12
|
52 score on a scale
Standard Deviation 18
|
55 score on a scale
Standard Deviation 21
|
56 score on a scale
Standard Deviation 24
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Crossover
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 |
Acupuncture
n=47 participants at risk
Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
Standard of Care
n=47 participants at risk
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Standard of care: standard of care home exercise program
|
Crossover
n=39 participants at risk
At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Non Serious Adverse Event
|
8.5%
4/47 • Number of events 4 • 90 days
|
0.00%
0/47 • 90 days
|
0.00%
0/39 • 90 days
|
|
Gastrointestinal disorders
Non Serious Adverse Event
|
0.00%
0/47 • 90 days
|
2.1%
1/47 • Number of events 1 • 90 days
|
0.00%
0/39 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place