Plantar FascitisNCT03015116

Photobiomodulation for Plantar Fasciitis

A study testing Stretching, Cryotherapy and Photobiomodulation Low Power in people with Plantar Fascitis, run by Landstuhl Regional Medical Center at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Plantar Fascitis
What is being tested?: Stretching, Cryotherapy and Photobiomodulation Low Power
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteGermany
Study dates: 12 Jan 2017to 28 Feb 2020
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Between ages of 18 - 65 years
Eligible for care at Landstuhl Regional Medical Center
Diagnosis of PF by healthcare provider based on accepted diagnostic criteria
Have experienced symptoms of PF for at least 3 months
Able to read and understand English language for consent purposes
Able to commit to 6 week intervention and 3 and 6 month follow-up

Who cannot join

Pregnant or plan on becoming pregnant during intervention period (Safety of PBM not established in pregnancy)
History of traumatic injury to symptomatic foot/feet
Diagnosis of calcaneal fracture
Have previously had corticosteroid injections, surgery, or other invasive treatment for same condition
Greater than 15% of calf area covered in tattoos/ink/scarring (Pigment in ink can absorb light, causing overheating of skin)
History of neuropathy or unable to detect changes in skin temperature (increased risk of skin warming due to inability to detect change)
Currently using medications associated with sensitivity to heat or light (e.g. amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)(8) Concurrent participation in another research study addressing pain issue

Trial locations and contacts

1 site in 1 country.

Germany1 site

Landstuhl Regional Medical Center
Landstuhl, APO AE, 09180

Other trials in Germany

About this study

Official title: Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis

BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and beneficiaries 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 (PBM), or low level laser therapy, 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. Unfortunately, previous studies of PBM for treatment of plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on its clinical effectiveness.

SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the clinical effectiveness of photobiomodulation in conjunction with and compared to usual care to improve function and decrease pain and in patients. 3. Assess the difference between two photobiomodulation dose parameters in conjunction with and compared to usual care for plantar fasciitis treatment.

DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6 month) follow-up, measures of foot function and pain will be collected for analysis. The proposed methods will allow the study team to establish if PBM accelerates recovery compared to usual care, as well as determining the optimal dose for future trials comparing PBM to other, more invasive, therapies for plantar fasciitis.

Conditions: Plantar Fascitis
Being tested: Stretching, Cryotherapy, Photobiomodulation Low Power, Photobiomodulation High Power
Keywords: photobiomodulation, plantar fasciitis
Medical subject headings: Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

StretchingOther
Daily foot and ankle stretching protocol
CryotherapyOther
Also called Ice
Daily cryotherapy in conjunction with stretching
Photobiomodulation Low PowerDevice
Also called Low Level Laser therapy, low level light therapy
Photobiomodulation treatment with 10W power output
Photobiomodulation High PowerDevice
Also called Low level laser therapy, low level light therapy
Photobiomodulation treatment with 25W power output

Study groups in NCT03015116
Study group	Role	What they receive
Usual Care	Active comparator	Participants will complete 6 weeks of stretching and cryotherapy Receives: Other: Stretching; Other: Cryotherapy
PBM 10 Watts	Experimental	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 Receives: Other: Stretching; Other: Cryotherapy; Device: Photobiomodulation Low Power
PBM 25 Watts	Experimental	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 Receives: Other: Stretching; Other: Cryotherapy; Device: Photobiomodulation High Power

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 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.
Measured: Baseline, 3 weeks, and 6 weeks
Defense and Veterans Pain Rating Scale (DVPRS)
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.
Measured: Baseline, 3 weeks, and 6 weeks
Foot and Ankle Ability Measure (FAAM) Long-term
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.
Measured: 3 months and 6 months
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
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.
Measured: 3 months and 6 months

Secondary outcomes (1)

Ankle Dorsiflexion
Measures 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.
Measured: % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 201728 Feb 2020

First posted9 Jan 2017 (estimated)
Study start12 Jan 2017
Primary completion31 Oct 2018
Study completion28 Feb 2020

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.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03015116
Sponsor's protocol ID: M-10548
Status last verified: Sep 2021
First submitted: 4 Jan 2017
Last updated: 21 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
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All Plantar Fascitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis
ClinicalTrials.gov ID: NCT03015116
Acronym / sponsor ID: M-10548
Conditions: Plantar Fascitis
Keywords: photobiomodulation, plantar fasciitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Landstuhl Regional Medical CenterUS federal agency
Study start: 12 Jan 2017 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 9 Jan 2017 (estimated)
Results: Posted 21 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Usual Care	Active comparator	Other: Stretching, Other: CryotherapyParticipants will complete 6 weeks of stretching and cryotherapy
PBM 10 Watts	Experimental	Other: Stretching, Other: Cryotherapy, Device: Photobiomodulation Low PowerParticipants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
PBM 25 Watts	Experimental	Other: Stretching, Other: Cryotherapy, Device: Photobiomodulation High PowerParticipants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Between ages of 18 - 65 years
Eligible for care at Landstuhl Regional Medical Center
Diagnosis of PF by healthcare provider based on accepted diagnostic criteria
Have experienced symptoms of PF for at least 3 months
Able to read and understand English language for consent purposes

Key exclusion criteria (7 listed)

Pregnant or plan on becoming pregnant during intervention period (Safety of PBM not established in pregnancy)
History of traumatic injury to symptomatic foot/feet
Diagnosis of calcaneal fracture
Have previously had corticosteroid injections, surgery, or other invasive treatment for same condition
Greater than 15% 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
StretchingDaily foot and ankle stretching protocol	Other	PBM 10 Watts, PBM 25 Watts, Usual Care
CryotherapyAlso: IceDaily cryotherapy in conjunction with stretching	Other	PBM 10 Watts, PBM 25 Watts, Usual Care
Photobiomodulation Low PowerAlso: Low Level Laser therapy, low level light therapyPhotobiomodulation treatment with 10W power output	Device	PBM 10 Watts
Photobiomodulation High PowerAlso: Low level laser therapy, low level light therapyPhotobiomodulation treatment with 25W power output	Device	PBM 25 Watts

Primary outcome

Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline, 3 weeks, and 6 weeks
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.
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: Baseline, 3 weeks, and 6 weeks
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.
Foot and Ankle Ability Measure (FAAM) Long-term
Time frame: 3 months and 6 months
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.
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Time frame: 3 months and 6 months
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.

1 secondary outcome

Ankle Dorsiflexion
Time frame: % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks

Results and safety

Results posted to the registry on 21 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	38	31
PBM 10 Watts	38	36
PBM 25 Watts	38	36

Primary outcome: Foot and Ankle Ability Measure (FAAM)

Time frame: Baseline, 3 weeks, and 6 weeks. Mean (95% Confidence Interval). Unit: percentage of total score

Measure	Usual Care n = 31	PBM 10 Watts n = 36	PBM 25 Watts n = 36
Baseline ADL Subscale	66.2 (61.2 to 71.2)	72.4 (67.3 to 77.4)	69.9 (64.8 to 74.9)
Week 3 ADL Subscale	69.3 (63.9 to 74.9)	81.4 (76.2 to 86.5)	78.5 (73.4 to 83.6)
Week 6 ADL Subscale	70.4 (65.1 to 75.7)	82.9 (77.7 to 88.0)	82.3 (77.2 to 87.4)
Baseline Sports Subscale	46.4 (39.4 to 53.3)	46.5 (39.5 to 53.5)	46.3 (39.3 to 53.3)
Week 3 Sports Subscale	46.6 (39.2 to 54.0)	62.4 (55.3 to 69.5)	62.0 (55.1 to 68.9)
Week 6 Sports Subscale	53.9 (46.6 to 61.1)	67.7 (60.6 to 74.4)	65.7 (58.7 to 72.7)

Population analysed: 7 withdrew from Usual Care group; 2 each from treatment groups.

Primary outcome: Defense and Veterans Pain Rating Scale (DVPRS)

Time frame: Baseline, 3 weeks, and 6 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Usual Care n = 31	PBM 10 Watts n = 36	PBM 25 Watts n = 36
Baseline 24 Hour Pain	4.031 (3.215 to 4.848)	4.146 (3.505 to 4.786)	3.763 (3.110 to 4.415)
Week 3 24 Hour Pain	3.634 (2.658 to 4.610)	2.948 (2.182 to 3.714)	2.863 (2.082 to 3.644)
Week 6 24 Hour Pain	3.652 (2.695 to 6.608)	2.61 (1.859 to 3.360)	2.943 (2.178 to 3.708)
Baseline Activity Interference	3.462 (2.516 to 4.408)	3.869 (3.169 to 4.570)	3.798 (3.018 to 4.578)
Week 3 Activity Interference	3.513 (2.522 to 4.503)	2.696 (1.962 to 3.430)	2.777 (1.960 to 3.594)
Week 6 Activity Interferece	3.555 (2.608 to 4.501)	2.244 (1.543 to 2.945)	2.736 (1.955 to 3.516)
Baseline Sleep Interference	1.857 (0.966 to 2.748)	2.548 (1.888 to 3.207)	1.667 (0.932 to 2.401)
Week 3 Sleep Interference	2.269 (1.336 to 3.202)	1.986 (1.296 to 2.677)	1.229 (0.460 to 1.998)

Population analysed: 7 withdrew from Usual Care group; 2 each from treatment groups.

Primary outcome: Foot and Ankle Ability Measure (FAAM) Long-term

Time frame: 3 months and 6 months. Mean (95% Confidence Interval). Unit: percentage of total score

Measure	PBM 10 Watts n = 28	PBM 25 Watts n = 36
3 Months ADL Subscale	80.3 (74.6 to 85.9)	81.5 (76.1 to 86.8)
3 Months Sports Subscale	62.4 (53.9 to 70.9)	67.6 (59.6 to 75.7)
6 Months ADL Subscale	82.0 (76.1 to 87.9)	82.2 (76.7 to 87.8)
6 Months Sports Subscale	65.4 (56.5 to 74.3)	69.0 (60.6 to 77.3)

Population analysed: 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.

Primary outcome: Defense and Veterans Pain Rating Scale (DVPRS) Long-term

Time frame: 3 months and 6 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	PBM 10 Watts n = 28	PBM 25 Watts n = 36
Month 3 24 Hour Pain	2.449 (1.688 to 3.211)	1.977 (1.315 to 2.639)
Month 6 24 Hour Pain	2.126 (1.350 to 2.901)	2.148 (1.450 to 2.847)
Month 3 Activity Interference	2.583 (1.828 to 3.337)	1.995 (1.286 to 2.704)
Month 6 Activity Interference	2.326 (1.540 to 3.113)	1.818 (1.094 to 2.542)
Month 3 Sleep Interference	1.691 (0.974 to 2.409)	0.720 (0.146 to 1.294)
Month 6 Sleep Interference	1.541 (0.796 to 2.287)	0.880 (0.149 to 1.294)
Month 3 Mood Interference	1.770 (1.094 to 2.445)	1.034 (0.399 to 1.669)
Month 6 Mood Interference	1.614 (0.910 to 2.317)	1.157 (0.509 to 1.805)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the six weeks of active study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 38 (0%)	0 of 38 (0%)	0 of 38
PBM 10 Watts	0 of 38 (0%)	1 of 38 (2.6%)	0 of 38
PBM 25 Watts	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Limitations and caveats (from the sponsor): No sham group to neutralize bias related to intervention; Not able to compare the usual care group to the intervention group in long term follow up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Ann K Ketz, PhD principal investigator

LRMC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stretching, Cryotherapy and Photobiomodulation Low Power in people with Plantar Fascitis, run by Landstuhl Regional Medical Center at 1 site in Germany.

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 7 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 21 Sep 2021. 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 Germany. 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. 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 21 Sep 2021). 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, 3 weeks, and 6 weeks). The study lists 4 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 NCT03015116.

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 21 Sep 2021.