Trial Outcomes & Findings for Photobiomodulation for Plantar Fasciitis (NCT NCT03015116)
NCT ID: NCT03015116
Last Updated: 2021-09-21
Results Overview
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Baseline, 3 weeks, and 6 weeks
Results posted on
2021-09-21
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
38
|
|
Overall Study
COMPLETED
|
31
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
2
|
Reasons for withdrawal
| Measure |
Usual Care
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
|
Overall Study
Subject has New Medical Status
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Photobiomodulation for Plantar Fasciitis
Baseline characteristics by cohort
| Measure |
Usual Care
n=38 Participants
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=38 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
n=38 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
38 participants
n=5 Participants
|
114 participants
n=4 Participants
|
|
Body Mass Index
Underweight (Less than 18.5)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Body Mass Index
Normal Weight (18.5 - 24.9)
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Body Mass Index
Overweight (25-29.9)
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Body Mass Index
Obese (Greater than or Equal to 30.0)
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Number of Months with Plantar Fasciitis or Plantar Heel Pain
0 to 6 Months
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Number of Months with Plantar Fasciitis or Plantar Heel Pain
7 to 12 Months
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Number of Months with Plantar Fasciitis or Plantar Heel Pain
13 to 24 Months
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Number of Months with Plantar Fasciitis or Plantar Heel Pain
Greater than 24 months
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Number of Months with Plantar Fasciitis or Plantar Heel Pain
Missing Data
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type I
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type II
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type III
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type V
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Missing Data
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 weeks, and 6 weeksPopulation: 7 withdrew from Usual Care group; 2 each from treatment groups.
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
Outcome measures
| Measure |
Usual Care
n=31 Participants
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=36 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
n=36 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Baseline ADL Subscale
|
66.2 percentage of total score
Interval 61.2 to 71.2
|
72.4 percentage of total score
Interval 67.3 to 77.4
|
69.9 percentage of total score
Interval 64.8 to 74.9
|
|
Foot and Ankle Ability Measure (FAAM)
Week 3 ADL Subscale
|
69.3 percentage of total score
Interval 63.9 to 74.9
|
81.4 percentage of total score
Interval 76.2 to 86.5
|
78.5 percentage of total score
Interval 73.4 to 83.6
|
|
Foot and Ankle Ability Measure (FAAM)
Week 6 ADL Subscale
|
70.4 percentage of total score
Interval 65.1 to 75.7
|
82.9 percentage of total score
Interval 77.7 to 88.0
|
82.3 percentage of total score
Interval 77.2 to 87.4
|
|
Foot and Ankle Ability Measure (FAAM)
Baseline Sports Subscale
|
46.4 percentage of total score
Interval 39.4 to 53.3
|
46.5 percentage of total score
Interval 39.5 to 53.5
|
46.3 percentage of total score
Interval 39.3 to 53.3
|
|
Foot and Ankle Ability Measure (FAAM)
Week 3 Sports Subscale
|
46.6 percentage of total score
Interval 39.2 to 54.0
|
62.4 percentage of total score
Interval 55.3 to 69.5
|
62.0 percentage of total score
Interval 55.1 to 68.9
|
|
Foot and Ankle Ability Measure (FAAM)
Week 6 Sports Subscale
|
53.9 percentage of total score
Interval 46.6 to 61.1
|
67.7 percentage of total score
Interval 60.6 to 74.4
|
65.7 percentage of total score
Interval 58.7 to 72.7
|
PRIMARY outcome
Timeframe: Baseline, 3 weeks, and 6 weeksPopulation: 7 withdrew from Usual Care group; 2 each from treatment groups.
Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.
Outcome measures
| Measure |
Usual Care
n=31 Participants
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=36 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
n=36 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Baseline 24 Hour Pain
|
4.031 score on a scale
Interval 3.215 to 4.848
|
4.146 score on a scale
Interval 3.505 to 4.786
|
3.763 score on a scale
Interval 3.11 to 4.415
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 3 24 Hour Pain
|
3.634 score on a scale
Interval 2.658 to 4.61
|
2.948 score on a scale
Interval 2.182 to 3.714
|
2.863 score on a scale
Interval 2.082 to 3.644
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 6 24 Hour Pain
|
3.652 score on a scale
Interval 2.695 to 6.608
|
2.61 score on a scale
Interval 1.859 to 3.36
|
2.943 score on a scale
Interval 2.178 to 3.708
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Baseline Activity Interference
|
3.462 score on a scale
Interval 2.516 to 4.408
|
3.869 score on a scale
Interval 3.169 to 4.57
|
3.798 score on a scale
Interval 3.018 to 4.578
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 3 Activity Interference
|
3.513 score on a scale
Interval 2.522 to 4.503
|
2.696 score on a scale
Interval 1.962 to 3.43
|
2.777 score on a scale
Interval 1.96 to 3.594
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 6 Activity Interferece
|
3.555 score on a scale
Interval 2.608 to 4.501
|
2.244 score on a scale
Interval 1.543 to 2.945
|
2.736 score on a scale
Interval 1.955 to 3.516
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Baseline Sleep Interference
|
1.857 score on a scale
Interval 0.966 to 2.748
|
2.548 score on a scale
Interval 1.888 to 3.207
|
1.667 score on a scale
Interval 0.932 to 2.401
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 3 Sleep Interference
|
2.269 score on a scale
Interval 1.336 to 3.202
|
1.986 score on a scale
Interval 1.296 to 2.677
|
1.229 score on a scale
Interval 0.46 to 1.998
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 6 Sleep Interference
|
1.748 score on a scale
Interval 0.9 to 2.596
|
1.476 score on a scale
Interval 0.848 to 2.104
|
1.111 score on a scale
Interval 0.412 to 1.811
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Baseline Mood Interference
|
2.496 score on a scale
Interval 1.577 to 3.414
|
2.363 score on a scale
Interval 1.682 to 3.043
|
2.164 score on a scale
Interval 1.406 to 2.921
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 3 Mood Interference
|
2.630 score on a scale
Interval 1.662 to 3.599
|
1.530 score on a scale
Interval 0.813 to 2.247
|
1.589 score on a scale
Interval 0.79 to 2.387
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 6 Mood Interference
|
2.092 score on a scale
Interval 1.212 to 2.973
|
1.125 score on a scale
Interval 0.473 to 1.777
|
1.486 score on a scale
Interval 0.76 to 2.211
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Baseline Stress Interference
|
2.471 score on a scale
Interval 1.489 to 3.462
|
2.358 score on a scale
Interval 1.631 to 3.085
|
2.215 score on a scale
Interval 1.406 to 3.024
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 3 Stress Interference
|
2.504 score on a scale
Interval 1.534 to 3.475
|
1.433 score on a scale
Interval 0.77 to 2.207
|
1.646 score on a scale
Interval 0.846 to 2.446
|
|
Defense and Veterans Pain Rating Scale (DVPRS)
Week 6 Stress Interference
|
2.345 score on a scale
Interval 1.441 to 3.248
|
1.031 score on a scale
Interval 0.62 to 1.699
|
1.450 score on a scale
Interval 0.705 to 2.195
|
PRIMARY outcome
Timeframe: 3 months and 6 monthsPopulation: Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=36 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Foot and Ankle Ability Measure (FAAM) Long-term
3 Months ADL Subscale
|
80.3 percentage of total score
Interval 74.6 to 85.9
|
81.5 percentage of total score
Interval 76.1 to 86.8
|
—
|
|
Foot and Ankle Ability Measure (FAAM) Long-term
3 Months Sports Subscale
|
62.4 percentage of total score
Interval 53.9 to 70.9
|
67.6 percentage of total score
Interval 59.6 to 75.7
|
—
|
|
Foot and Ankle Ability Measure (FAAM) Long-term
6 Months ADL Subscale
|
82.0 percentage of total score
Interval 76.1 to 87.9
|
82.2 percentage of total score
Interval 76.7 to 87.8
|
—
|
|
Foot and Ankle Ability Measure (FAAM) Long-term
6 Months Sports Subscale
|
65.4 percentage of total score
Interval 56.5 to 74.3
|
69.0 percentage of total score
Interval 60.6 to 77.3
|
—
|
PRIMARY outcome
Timeframe: 3 months and 6 monthsPopulation: Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.
Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.
Outcome measures
| Measure |
Usual Care
n=28 Participants
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=36 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 3 24 Hour Pain
|
2.449 score on a scale
Interval 1.688 to 3.211
|
1.977 score on a scale
Interval 1.315 to 2.639
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 6 24 Hour Pain
|
2.126 score on a scale
Interval 1.35 to 2.901
|
2.148 score on a scale
Interval 1.45 to 2.847
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 3 Activity Interference
|
2.583 score on a scale
Interval 1.828 to 3.337
|
1.995 score on a scale
Interval 1.286 to 2.704
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 6 Activity Interference
|
2.326 score on a scale
Interval 1.54 to 3.113
|
1.818 score on a scale
Interval 1.094 to 2.542
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 3 Sleep Interference
|
1.691 score on a scale
Interval 0.974 to 2.409
|
0.720 score on a scale
Interval 0.146 to 1.294
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 6 Sleep Interference
|
1.541 score on a scale
Interval 0.796 to 2.287
|
0.880 score on a scale
Interval 0.149 to 1.294
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 3 Mood Interference
|
1.770 score on a scale
Interval 1.094 to 2.445
|
1.034 score on a scale
Interval 0.399 to 1.669
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 6 Mood Interference
|
1.614 score on a scale
Interval 0.91 to 2.317
|
1.157 score on a scale
Interval 0.509 to 1.805
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 3 Stress Interference
|
1.174 score on a scale
Interval 0.484 to 1.864
|
1.040 score on a scale
Interval 0.378 to 1.702
|
—
|
|
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Month 6 Stress Interference
|
1.391 score on a scale
Interval 0.579 to 2.204
|
1.040 score on a scale
Interval 0.261 to 1.819
|
—
|
SECONDARY outcome
Timeframe: % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeksMeasures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group.
Outcome measures
| Measure |
Usual Care
n=30 Participants
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=35 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
n=35 Participants
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Ankle Dorsiflexion
% Change baseline to 3 weeks
|
9.14 percentage of change over time
Standard Error 0.029
|
7.16 percentage of change over time
Standard Error 0.036
|
17.24 percentage of change over time
Standard Error 0.045
|
|
Ankle Dorsiflexion
% change week 3 to week 6
|
6.03 percentage of change over time
Standard Error 0.037
|
9.02 percentage of change over time
Standard Error 0.047
|
3.86 percentage of change over time
Standard Error 0.023
|
|
Ankle Dorsiflexion
% change baseline to week 6
|
11.6 percentage of change over time
Standard Error 0.055
|
13.22 percentage of change over time
Standard Error 0.043
|
19.79 percentage of change over time
Standard Error 0.045
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PBM 10 Watts
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PBM 25 Watts
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 |
Usual Care
n=38 participants at risk
Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
|
PBM 10 Watts
n=38 participants at risk
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
|
PBM 25 Watts
n=38 participants at risk
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output
|
|---|---|---|---|
|
Nervous system disorders
Numbness and Tingling
|
0.00%
0/38 • Adverse event data were collected during the six weeks of active study treatment.
|
2.6%
1/38 • Number of events 1 • Adverse event data were collected during the six weeks of active study treatment.
|
0.00%
0/38 • Adverse event data were collected during the six weeks of active study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place