Plantar FascitisNCT05763381
Low-Level Laser Therapy for Plantar Fasciitis
A study testing Photobiomodulation Therapy (PBMT) in people with Plantar Fascitis, run by The Geneva Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Photobiomodulation Therapy (PBMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DEERS eligible
- Able to read and understand English language for consent purposes
- Experience pain in the bottom of foot and/or heel at any time during the day
- Diagnosis of Plantar Fasciitis (PF) by a healthcare provider based on accepted diagnostic criteria
- Abel to commit to study procedures, including a 6-week intervention and 3 month follow-up
- Have experienced symptoms of PF for at least 3 months
Who cannot join
- Diagnosed with a calcaneal (heel) fracture by a healthcare provider
- Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy)
- History of traumatic injury to symptomatic foot/feet
- Previous surgery, or other invasive treatment for same condition
- Significant portion of calf area covered in tattoos/ink/scarring (pigment in ink can absorb light, causing overheating of skin)
- History of neuropathy or inability to detect changes in skin temperature (increased risk of skin warming due to inability to detect change)
Show all 11Show fewer
- Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
- Concurrent participation in another research study addressing pain issue
- Current use of pacemaker
- Current or chronic sciatica resulting in chronic or intermittent lower extremity pain, numbness, or tingling
- Previous enrollment in this study for contralateral foot
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Photobiomodulation Therapy for Plantar Fasciitis: A Single-Blind Randomized Control Trial
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.
Read more
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.
Read the detailed description
Recruitment, Pre-Screening (before consent), Study Introduction \& Informed Consent:
Potential participants will be identified via four methods:
- Under the provisions of the Partial HIPAA Waiver, local study providers will review medical records of patients coming into the Orthopedic and Podiatry Clinics for suspected plantar fasciitis to identify prospective research participants for the purposes of seeking their authorization to participate/use their protected health information for this research study. In these cases, the study team will receive approval from the potential participant's provider prior to approaching for possible study participation.
- Direct referral from local healthcare providers in the local Family Medicine, Podiatry, Physical Therapy, and Physical Medicine \& Rehabilitation (PM\&R) clinics.
- Patients may self-refer to participate in the study. Interested potential participants will be able to contact a member of the study team via phone or email. Potential participants who contact the study team directly will be instructed to access the Physical Therapy clinic or their primary care manager for a physical exam and diagnosis of Plantar Fasciitis (PF) or confirmation of a previous PF diagnosis.
- Study advertisements will be posted, and copies will be provided to clinic staff.
Eligibility will be determined in person. If the potential participant meets eligibility criteria as determined by the Inclusion/Exclusion CRF and expresses interest in participating, an authorized study team member will initiate the formal consent discussion and, if applicable, obtain informed consent.
Baseline Data Collection (post-consent): Prior to receiving the assigned study treatment, participants will provide their contact information and complete a series of baseline outcome measures (Demographics CRF and Baseline Data Collection CRF) and have their plantar fascia thickness measured within the Podiatry clinic. A study team member will also acquire measurements of the participant's calf, ankle, and foot to calculate the appropriate PBMT dose.
Randomization: Participants will be randomly assigned to a study group (PBMT+UC or Sham PBMT+UC) using a computer-generated randomization model prepared by the study biostatistician.
Study Treatments (PBMT+UC or Sham PBMT+UC): All participants, regardless of study arm assignment, will be asked to complete the UC Protocol, which consists of a daily regimen of stretching and cryotherapy that includes 3-5 minutes of stretching upon waking, then approximately 3-5 minutes of stretching and 3-5 minutes of cryotherapy throughout the day, for the duration of 6 weeks.
Participants will receive PBMT or sham-PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on the treatment area (size).
Photobiomodulation Therapy (PBMT): PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. The Smart Hand Piece is calibrated to shutoff when moving too slowly, and warn the operator when moving too fast by vibrating. The therapy is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling sapphire massage ball. The PBM therapy will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin.
Sham-Photobiomodulation Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons. The following safeguards will be in place to prevent exposure to PBM and potential unexpected crossover or protocol deviations, as follows:
The PBM device requires multiple steps to emit photons. The device first must be powered on, then settings are selected (in this case, power will be 25 watts, and the time will be determined by the algorithm based on the treatment area measurements). Next, there is a 'standby' button that is activated on the touch screen, and finally, there is a finger switch on the handpiece that must be pressed to initiate the treatment. There is a beep that sounds for the duration of the active treatment.
For the sham condition, the device will be turned on and the settings will be selected, but the standby button and the finger switch on the handpiece will not be activated. This way, there is no chance that the device will be emitting photons. Since the device will not emit active treatment, there will not be a beeping sound from the device; this beeping noise will be replicated in another way for the sham-PBMT. At the completion of the initial 6 weeks, Sham-PBMT participants will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If Sham-PBMT participants choose to cross-over and receive active PBMT, participants will re-complete all of the original study procedures (with the exception of screening).
Follow Up Data Collection: In addition to their 3x weekly for 3 weeks PBM or Sham-PBM treatments, participants will report to the study team in person approximately 3 weeks (+/- 3 days) and 6 weeks (+/- 3 days) after the start of their PBM or Sham-PBM treatment to complete the follow-up questionnaires, turn in their Pain Diary, and undergo ultrasound imaging to measure changes in plantar fascia thickness at 3-weeks and 6-weeks.
Long-term follow up questionnaires will be captured remotely (e.g., entered directly into REDCap using a personalized coded link with no log-in required, verbally over the phone with a study team member, etc.) at approximately 3-months (+/- 10 days/weeks) post-start of PBM treatment. For Sham-PBMT participants who cross-over, their 3-month follow-up will be timed from the first day of their active PBM treatment, not their Sham-PBM treatment. Reminder phone calls and emails will be sent to participants at the phone and email address provided to the study team before the 3-month follow-up time point. Participants will be evaluated for adverse events at each follow-up time point and any complications will be documented.
Study participation ends after the 3-month follow-up research activities are completed. Participants initially randomized to the PBMT group will participate in the study for approximately 3 months. Participants initially assigned to the Sham-PBMT group who choose to cross-over and receive active PBMT post-unblinding will be in the study for approximately 4.5 months total.
Ultrasound Measurement: Plantar fascia thickness will be measured by an MSK US trained provider utilizing an ultrasound system. The participant will be identified on the ultrasound system using only the assigned participant ID. The patient will be 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 will be evaluated in the long axis to determine the site to be measured as identified by the bony contour demonstrated. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured will be from the edge of the bone to the outer layer of the plantar fascia.
Plantar fascia thickness will be measured in two orthogonal planes (90 degrees different - long axis and short axis of the structure) at the site identified by the bone contour. The measurement will be conducted by MSK US trained providers, either in Physical Therapy or Physical Medicine and Rehab clinics.
- Conditions
- Plantar Fascitis
- Being tested
- Photobiomodulation Therapy (PBMT), Sham-Photobiomodualtion Therapy (Sham-PBMT)
- Keywords
- Plantar Fasciitis, Photobiomodulation Therapy, Tendinopathy, Low Level Laser Therapy
- Medical subject headings
- Fasciitis, Plantar, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation Therapy (PBMT)Device
Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size). PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
Sham-Photobiomodualtion Therapy (Sham-PBMT)Device
Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons.
| Study group | Role | What they receive |
|---|---|---|
| The Usual Care + PBM Group | Active comparator | Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. Receives: Device: Photobiomodulation Therapy (PBMT) |
| The Usual Care + Sham (Placebo) PBM Group | Placebo comparator | Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment.
At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment. Receives: Device: Sham-Photobiomodualtion Therapy (Sham-PBMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure (FAAM)
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 and 0% being dysfunction.
Measured: Baseline
Foot and Ankle Ability Measure (FAAM)
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 and 0% being dysfunction.
Measured: 3-Week
Foot and Ankle Ability Measure (FAAM)
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 and 0% being dysfunction.
Measured: 6-week
Foot and Ankle Ability Measure (FAAM)
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 and 0% being dysfunction.
Measured: 3-month
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
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.
Measured: Baseline
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
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.
Measured: 3-Week
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
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.
Measured: 6-Week
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
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.
Measured: 3-Month
Ultrasound Measurement (Plantar Fascial Thickness)
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 plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Measured: Baseline
Ultrasound Measurement (Plantar Fascial Thickness)
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 plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Measured: 3-Week
Ultrasound Measurement (Plantar Fascial Thickness)
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 plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Measured: 6-Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start11 Aug 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two treatment groups: usual care with PBM therapy, or usual care with sham PBM therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Musculoskeletal Injury Rehabilitation Research for Operational Readiness
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763381
- Sponsor's protocol ID
- 222072
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 2023
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Any research data shared with an approved agency for review will be linked only to the participant's unique study ID and not with the personal identity of the participant. If the research data is used in scholarly presentations or journal articles, the investigators will protect the anonymity of individual participants and report only aggregate data where appropriate. Participants will not be individually identified in any publication or presentation of research results.
Publications
Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.
PubMed 19952249Dyck DD Jr, Boyajian-O'Neill LA. Plantar fasciitis. Clin J Sport Med. 2004 Sep;14(5):305-9. doi: 10.1097/00042752-200409000-00010. No abstract available.
PubMed 15377971Rosenbaum AJ, DiPreta JA, Misener D. Plantar heel pain. Med Clin North Am. 2014 Mar;98(2):339-52. doi: 10.1016/j.mcna.2013.10.009. Epub 2013 Dec 10.
PubMed 24559879DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
PubMed 12851352Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
PubMed 24626080Franceschi F, Papalia R, Paciotti M, Franceschetti E, Di Martino A, Maffulli N, Denaro V. Obesity as a risk factor for tendinopathy: a systematic review. Int J Endocrinol. 2014;2014:670262. doi: 10.1155/2014/670262. Epub 2014 Aug 19.
PubMed 25214839Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.
PubMed 21882780Roy TC, Knapik JJ, Ritland BM, Murphy N, Sharp MA. Risk factors for musculoskeletal injuries for soldiers deployed to Afghanistan. Aviat Space Environ Med. 2012 Nov;83(11):1060-6. doi: 10.3357/asem.3341.2012.
PubMed 23156094Cameron KL, Owens BD. The burden and management of sports-related musculoskeletal injuries and conditions within the US military. Clin Sports Med. 2014 Oct;33(4):573-89. doi: 10.1016/j.csm.2014.06.004.
PubMed 25280610Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.
PubMed 12756315Orchard J. Plantar fasciitis. BMJ. 2012 Oct 10;345:e6603. doi: 10.1136/bmj.e6603. No abstract available.
PubMed 23054045Franceschi F, Papalia R, Franceschetti E, Paciotti M, Maffulli N, Denaro V. Platelet-rich plasma injections for chronic plantar fasciopathy: a systematic review. Br Med Bull. 2014 Dec;112(1):83-95. doi: 10.1093/bmb/ldu025. Epub 2014 Sep 19.
PubMed 25239050Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3.
PubMed 19083680Tountas AA, Fornasier VL. Operative treatment of subcalcaneal pain. Clin Orthop Relat Res. 1996 Nov;(332):170-8. doi: 10.1097/00003086-199611000-00023.
PubMed 8913160Miller LE, Latt DL. Chronic Plantar Fasciitis is Mediated by Local Hemodynamics: Implications for Emerging Therapies. N Am J Med Sci. 2015 Jan;7(1):1-5. doi: 10.4103/1947-2714.150080.
PubMed 25709971
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy for Plantar Fasciitis: A Single-Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05763381
- Acronym / sponsor ID
- 222072
- Conditions
- Plantar Fascitis
- Keywords
- Plantar Fasciitis, Photobiomodulation Therapy, Tendinopathy, Low Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Musculoskeletal Injury Rehabilitation Research for Operational Readiness
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recruitment, Pre-Screening (before consent), Study Introduction \& Informed Consent:
Potential participants will be identified via four methods:
- Under the provisions of the Partial HIPAA Waiver, local study providers will review medical records of patients coming into the Orthopedic and Podiatry Clinics for suspected plantar fasciitis to identify prospective research participants for the purposes of seeking their authorization to participate/use their protected health information for this research study. In these cases, the study team will receive approval from the potential participant's provider prior to approaching for possible study participation.
- Direct referral from local healthcare providers in the local Family Medicine, Podiatry, Physical Therapy, and Physical Medicine \& Rehabilitation (PM\&R) clinics.
- Patients may self-refer to participate in the study. Interested potential participants will be able to contact a member of the study team via phone or email. Potential participants who contact the study team directly will be instructed to access the Physical Therapy clinic or their primary care manager for a physical exam and diagnosis of Plantar Fasciitis (PF) or confirmation of a previous PF diagnosis.
- Study advertisements will be posted, and copies will be provided to clinic staff.
Eligibility will be determined in person. If the potential participant meets eligibility criteria as determined by the Inclusion/Exclusion CRF and expresses interest in participating, an authorized study team member will initiate the formal consent discussion and, if applicable, obtain informed consent.
Baseline Data Collection (post-consent): Prior to receiving the assigned study treatment, participants will provide their contact information and complete a series of baseline outcome measures (Demographics CRF and Baseline Data Collection CRF) and have their plantar fascia thickness measured within the Podiatry clinic. A study team member will also acquire measurements of the participant's calf, ankle, and foot to calculate the appropriate PBMT dose.
Randomization: Participants will be randomly assigned to a study group (PBMT+UC or Sham PBMT+UC) using a computer-generated randomization model prepared by the study biostatistician.
Study Treatments (PBMT+UC or Sham PBMT+UC): All participants, regardless of study arm assignment, will be asked to complete the UC Protocol, which consists of a daily regimen of stretching and cryotherapy that includes 3-5 minutes of stretching upon waking, then approximately 3-5 minutes of stretching and 3-5 minutes of cryotherapy throughout the day, for the duration of 6 weeks.
Participants will receive PBMT or sham-PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on the treatment area (size).
Photobiomodulation Therapy (PBMT): PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. The Smart Hand Piece is calibrated to shutoff when moving too slowly, and warn the operator when moving too fast by vibrating. The therapy is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling sapphire massage ball. The PBM therapy will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin.
Sham-Photobiomodulation Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons. The following safeguards will be in place to prevent exposure to PBM and potential unexpected crossover or protocol deviations, as follows:
The PBM device requires multiple steps to emit photons. The device first must be powered on, then settings are selected (in this case, power will be 25 watts, and the time will be determined by the algorithm based on the treatment area measurements). Next, there is a 'standby' button that is activated on the touch screen, and finally, there is a finger switch on the handpiece that must be pressed to initiate the treatment. There is a beep that sounds for the duration of the active treatment.
For the sham condition, the device will be turned on and the settings will be selected, but the standby button and the finger switch on the handpiece will not be activated. This way, there is no chance that the device will be emitting photons. Since the device will not emit active treatment, there will not be a beeping sound from the device; this beeping noise will be replicated in another way for the sham-PBMT. At the completion of the initial 6 weeks, Sham-PBMT participants will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If Sham-PBMT participants choose to cross-over and receive active PBMT, participants will re-complete all of the original study procedures (with the exception of screening).
Follow Up Data Collection: In addition to their 3x weekly for 3 weeks PBM or Sham-PBM treatments, participants will report to the study team in person approximately 3 weeks (+/- 3 days) and 6 weeks (+/- 3 days) after the start of their PBM or Sham-PBM treatment to complete the follow-up questionnaires, turn in their Pain Diary, and undergo ultrasound imaging to measure changes in plantar fascia thickness at 3-weeks and 6-weeks.
Long-term follow up questionnaires will be captured remotely (e.g., entered directly into REDCap using a personalized coded link with no log-in required, verbally over the phone with a study team member, etc.) at approximately 3-months (+/- 10 days/weeks) post-start of PBM treatment. For Sham-PBMT participants who cross-over, their 3-month follow-up will be timed from the first day of their active PBM treatment, not their Sham-PBM treatment. Reminder phone calls and emails will be sent to participants at the phone and email address provided to the study team before the 3-month follow-up time point. Participants will be evaluated for adverse events at each follow-up time point and any complications will be documented.
Study participation ends after the 3-month follow-up research activities are completed. Participants initially randomized to the PBMT group will participate in the study for approximately 3 months. Participants initially assigned to the Sham-PBMT group who choose to cross-over and receive active PBMT post-unblinding will be in the study for approximately 4.5 months total.
Ultrasound Measurement: Plantar fascia thickness will be measured by an MSK US trained provider utilizing an ultrasound system. The participant will be identified on the ultrasound system using only the assigned participant ID. The patient will be 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 will be evaluated in the long axis to determine the site to be measured as identified by the bony contour demonstrated. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured will be from the edge of the bone to the outer layer of the plantar fascia.
Plantar fascia thickness will be measured in two orthogonal planes (90 degrees different - long axis and short axis of the structure) at the site identified by the bone contour. The measurement will be conducted by MSK US trained providers, either in Physical Therapy or Physical Medicine and Rehab clinics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two treatment groups: usual care with PBM therapy, or usual care with sham PBM therapy.
| Arm | Type | Receives |
|---|---|---|
| The Usual Care + PBM Group | Active comparator | Device: Photobiomodulation Therapy (PBMT)Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. |
| The Usual Care + Sham (Placebo) PBM Group | Placebo comparator | Device: Sham-Photobiomodualtion Therapy (Sham-PBMT)Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment. At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DEERS eligible
- Able to read and understand English language for consent purposes
- Experience pain in the bottom of foot and/or heel at any time during the day
- Diagnosis of Plantar Fasciitis (PF) by a healthcare provider based on accepted diagnostic criteria
- Abel to commit to study procedures, including a 6-week intervention and 3 month follow-up
Key exclusion criteria (11 listed)
- Diagnosed with a calcaneal (heel) fracture by a healthcare provider
- Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy)
- History of traumatic injury to symptomatic foot/feet
- Previous surgery, or other invasive treatment for same condition
- Significant portion of calf area covered in tattoos/ink/scarring (pigment in ink can absorb light, causing overheating of skin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation Therapy (PBMT)Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size). PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. | Device | The Usual Care + PBM Group |
| Sham-Photobiomodualtion Therapy (Sham-PBMT)Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons. | Device | The Usual Care + Sham (Placebo) PBM Group |
Primary outcome
Foot and Ankle Ability Measure (FAAM)
Time frame: 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 and 0% being dysfunction.
Foot and Ankle Ability Measure (FAAM)
Time frame: 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 and 0% being dysfunction.
Foot and Ankle Ability Measure (FAAM)
Time frame: 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 and 0% being dysfunction.
Foot and Ankle Ability Measure (FAAM)
Time frame: 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 and 0% being dysfunction.
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: 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.
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: 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.
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: 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.
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: 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.
Ultrasound Measurement (Plantar Fascial Thickness)
Time frame: Baseline
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 plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Ultrasound Measurement (Plantar Fascial Thickness)
Time frame: 3-Week
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 plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Ultrasound Measurement (Plantar Fascial Thickness)
Time frame: 6-Week
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 plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19952249Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.
- Background: PubMed 15377971Dyck DD Jr, Boyajian-O'Neill LA. Plantar fasciitis. Clin J Sport Med. 2004 Sep;14(5):305-9. doi: 10.1097/00042752-200409000-00010. No abstract available.
- Background: PubMed 24559879Rosenbaum AJ, DiPreta JA, Misener D. Plantar heel pain. Med Clin North Am. 2014 Mar;98(2):339-52. doi: 10.1016/j.mcna.2013.10.009. Epub 2013 Dec 10.
- Background: PubMed 12851352DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
- Background: PubMed 24626080Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
- Background: PubMed 25214839Franceschi F, Papalia R, Paciotti M, Franceschetti E, Di Martino A, Maffulli N, Denaro V. Obesity as a risk factor for tendinopathy: a systematic review. Int J Endocrinol. 2014;2014:670262. doi: 10.1155/2014/670262. Epub 2014 Aug 19.
- Background: PubMed 21882780Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.
- Background: PubMed 23156094Roy TC, Knapik JJ, Ritland BM, Murphy N, Sharp MA. Risk factors for musculoskeletal injuries for soldiers deployed to Afghanistan. Aviat Space Environ Med. 2012 Nov;83(11):1060-6. doi: 10.3357/asem.3341.2012.
- Background: PubMed 25280610Cameron KL, Owens BD. The burden and management of sports-related musculoskeletal injuries and conditions within the US military. Clin Sports Med. 2014 Oct;33(4):573-89. doi: 10.1016/j.csm.2014.06.004.
- Background: PubMed 12756315Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.
- Background: PubMed 23054045Orchard J. Plantar fasciitis. BMJ. 2012 Oct 10;345:e6603. doi: 10.1136/bmj.e6603. No abstract available.
- Background: PubMed 25239050Franceschi F, Papalia R, Franceschetti E, Paciotti M, Maffulli N, Denaro V. Platelet-rich plasma injections for chronic plantar fasciopathy: a systematic review. Br Med Bull. 2014 Dec;112(1):83-95. doi: 10.1093/bmb/ldu025. Epub 2014 Sep 19.
- Individual participant dataSharing planned: Yes. Any research data shared with an approved agency for review will be linked only to the participant's unique study ID and not with the personal identity of the participant. If the research data is used in scholarly presentations or journal articles, the investigators will protect the anonymity of individual participants and report only aggregate data where appropriate. Participants will not be individually identified in any publication or presentation of research results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy (PBMT) in people with Plantar Fascitis, run by The Geneva Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (FAAM) (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05763381, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.