Adults 18 to 64, any sex, with Plantar Fascitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Foot and Ankle Ability Measure (FAAM)Primary· Baseline
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-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). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction a
Activities of Daily Living (21- item)
Group
Value
95% CI
The Usual Care + PBM Group
47.00
± 13.97
The Usual Care + Sham (Placebo) PBM Group
45.28
± 12.42
Sports (7-item)
Group
Value
95% CI
The Usual Care + PBM Group
11.65
± 5.84
The Usual Care + Sham (Placebo) PBM Group
11.72
± 6.29
Foot and Ankle Ability Measure (FAAM)Primary· 3-Week
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-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). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction a
Activities of Daily Living (21- item)
Group
Value
95% CI
The Usual Care + PBM Group
54.00
± 11.82
The Usual Care + Sham (Placebo) PBM Group
53.79
± 12.68
Sports (7-item)
Group
Value
95% CI
The Usual Care + PBM Group
15.42
± 5.91
The Usual Care + Sham (Placebo) PBM Group
13.27
± 6.72
Foot and Ankle Ability Measure (FAAM)Primary· 6-week
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-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). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction a
Activities of Daily Living (21- item)
Group
Value
95% CI
The Usual Care + PBM Group
56.81
± 14.79
The Usual Care + Sham (Placebo) PBM Group
53.26
± 14.64
Sports (7-item)
Group
Value
95% CI
The Usual Care + PBM Group
17.84
± 6.60
The Usual Care + Sham (Placebo) PBM Group
13.58
± 7.06
Foot and Ankle Ability Measure (FAAM)Primary· 3-month
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-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). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction a
Activities of Daily Living (21- item)
Group
Value
95% CI
The Usual Care + PBM Group
58.29
± 18.06
The Usual Care + Sham (Placebo) PBM Group
52.00
± 18.69
Sports (7-item)
Group
Value
95% CI
The Usual Care + PBM Group
17.35
± 8.49
The Usual Care + Sham (Placebo) PBM Group
10.75
± 8.17
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)Primary· Baseline
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 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.
Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Group
Value
95% CI
The Usual Care + PBM Group
4.97
± 2.09
The Usual Care + Sham (Placebo) PBM Group
5.17
± 1.85
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)Primary· 3-Week
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 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.
Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Group
Value
95% CI
The Usual Care + PBM Group
4.19
± 2.09
The Usual Care + Sham (Placebo) PBM Group
4.03
± 1.83
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)Primary· 6-Week
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 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.
Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Group
Value
95% CI
The Usual Care + PBM Group
3.71
± 1.99
The Usual Care + Sham (Placebo) PBM Group
4.00
± 2.05
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)Primary· 3-Month
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 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.
Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plant
Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plant
Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plant
Group
Value
95% CI
The Usual Care + PBM Group
4.155
± 1.825
The Usual Care + Sham (Placebo) PBM Group
4.665
± 1.045
Foot and Ankle Ability Measure (FAAM)Secondary· 3-Week Cross-over
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-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). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction a
Activities of Daily Living (21- item)
Group
Value
95% CI
The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention
57.07
± 14.88
Sports (7-item)
Group
Value
95% CI
The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention
16.11
± 7.92
Adverse events — posted to ClinicalTrials.gov
Time frame: All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The Usual Care + PBM Group
Serious: 2/31 (6%)
Deaths: 0/31
The Usual Care + Sham (Placebo) PBM Group
Serious: 3/33 (9%)
Deaths: 0/33
The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention
Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation therapy (PBMT) uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as achilles tendinopathy and epicondylitis. A previous pilot study was completed in an active-duty military and civilian population, which demonstrated a positive effect of two PBM dose parameters on function and pain levels in participants with chronic PF when combined with stretching and ice. These positive findings from the aforementioned study are promising in the treatment of this common and debilitating issue, but require the addition of a sham comparison to rigorously eliminate any potential placebo effect of the treatment protocol, and further refine the treatment protocol in order to make evidence-based clinical recommendations. As such, proposing a follow-up study and the addition of an objective outcome measure will strengthen the impact of the study.
SPECIFIC AIM 1: To assess the clinical effectiveness of photobiomodulation compared to sham photobiomodulation to improve function and decrease pain.
SPECIFIC AIM 2: To evaluate the effectiveness of photobiomodulation compared to sham photobiomodulation to resolve plantar fascial thickening. DESIGN: A prospective randomized sham-controlled trial to meet the aims of the study.
METHOD: A sample of up to 100 active-duty military members will be randomly assigned to the Sham-PBMT or PBMT group. At baseline, during the treatment protocol, and at long-term (3 and 6 months) follow-up, measures of foot function, pain, and plantar fascial thickness will be collected for analysis. The proposed methods will allow the study team to establish if PBMT is clinically effective to accelerate recovery compared to Sham-PBMT and result in resolution of fascial thickening, decrease in pain, and improved function.
LONG-TERM GOAL: The long-term goals of the research include developing PBMT protocols for broad application to other painful and duty-limiting conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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· NA
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Other recruiting trials for Plantar Fascitis
Currently open trials in the same condition.
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· NA
· active not recruiting
NCT06536803 — Effects of High Load Strength Training With and Without Tissue Specific Planter Facia Stretching With Planter Fasciitis
· NA
· recruiting
NCT06706531 — Additional Effects of Dry Needling With Conventional Physical Therapy Versus Conventional Physical Therapy in Plantar Fa
· NA
· recruiting
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· NA
· active not recruiting
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Geneva Foundation
Last refreshed: 4 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05763381.