Plantar FasciitisHILTNCT07287046
A Single-Blind Randomized Controlled Study Comparing the Efficacy of High-Intensity Laser Therapy and Focused Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis
A study testing High power Laser therapy and Focused extracorporeal shock wave therapy in people with Plantar Fasciitis, run by Mahidol University.
Trial summary
This randomized controlled trial aims to evaluate the efficacy of High-Intensity Laser Therapy (HILT) and Focused Extracorporeal Shock Wave Therapy (fESWT) in reducing pain in patients with plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- High power Laser therapy and Focused extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years
- Pain was worse in the initial step after and an extended period of rest
- Pain was decreased initially after the first steps but exacerbated with increased activity
- VAS ≥ 4
- Pain was localized and sharp but not radiating,
- Pain was reproduced with palpation of the plantar fascia
Who cannot join
- Have Wound/Infection/tumor in treatment area
- History of foot trauma in 3 months
- History of intervention at plantar fascia in 6 months such as Ultrasound therapy, steroid injection, surgery or botulinum toxin injection
- Pain medication within one week before participation
- Patient wasn't desired to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Suttinon Jitjai, Dortor of Medicine contact
About this study
Official title: A Comparison of Efficacy Between High-intensity Laser Therapy and Focused Extracorporeal Shock Wave Therapy in Patient With Plantar Fasciitis; Single Blinded Randomize Controlled Study
This randomized controlled trial aims to evaluate the efficacy of High-Intensity Laser Therapy (HILT) and Focused Extracorporeal Shock Wave Therapy (fESWT) in reducing pain in patients with plantar fasciitis. The study also examines the effects of HILT and fESWT on health-related outcomes, including VAS-FA, FFI, plantar fascia thickness, and adverse events.
Researchers will compare HILT with fESWT as treatment options for patients with plantar fasciitis.
Participants will receive either HILT or fESWT along with an exercise program. They will attend follow-up visits to assess outcomes at 1, 2, 3, 6, and 12 weeks after the first treatment.
- Conditions
- Plantar Fasciitis
- Being tested
- High power Laser therapy, Focused extracorporeal shock wave therapy
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power Laser therapyDevice
High-power laser therapy (iLUX® XP) was applied using a power output of 6 W, an energy density of 5 J/cm², and a spot size of 10 cm², delivering a total energy of 150 J per session. Treatment consisted of 6 sessions, administered twice per week for 3 weeks
Focused extracorporeal shock wave therapyDevice
Focused extracorporeal shock wave therapy (fESWT) using the DUOLITH® SD1 (STORZ Medical) was applied at a frequency of 4 Hz, starting at an energy flux density of 0.2 mJ/mm² and gradually increased as tolerated. Each session consisted of 2,000 shocks, for a total of 3 sessions (one session per week)
| Study group | Role | What they receive |
|---|---|---|
| HILT group | Experimental | High-power laser therapy (iLUX® XP) was applied using a power output of 6 W, an energy density of 5 J/cm², and a spot size of 10 cm², delivering a total energy of 150 J per session. Treatment consisted of 6 sessions, administered twice per week for 3 weeks. Receives: Device: High power Laser therapy |
| fESWT group | Active comparator | Focused extracorporeal shock wave therapy (fESWT) using the DUOLITH® SD1 (STORZ Medical) was applied at a frequency of 4 Hz, starting at an energy flux density of 0.2 mJ/mm² and gradually increased as tolerated. Each session consisted of 2,000 shocks, for a total of 3 sessions (one session per week) Receives: Device: Focused extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm) Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain
Measured: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Secondary outcomes (4)
VAS-FA Thai version
The parameter used to assess the level of pain in several foot activities, 0-100 point scale, a higher score means a better outcome
Measured: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Foot function index Thai version
a self-reporting questionnaire covering several dimensions of foot function categorized in 3 subscales that quantify the impacts of foot problems on pain, disability and activity limitation. FFI use a horizontal numeric block rating scale with 10 equal size boxes ranging from 0 to 9. A higher score indicates a higher severity.
Measured: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Thickness of plantar fasciitis
The plantar fascia thickness was measured at the point of plantar fascial insertion into the calcaneus with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm). The quantitative measurement was achieved by recording the thickest part measured.
Measured: Pre-treatment, and 12-week post-treatment
Adverse events
Including post-treatment soreness, burns, a burning sensation, and hematoma
Measured: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start28 Feb 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287046
- Sponsor's protocol ID
- MURA2025/885
- Other IDs
- Ramathibodi Hospital
- Acronym
- HILT
- Status last verified
- Mar 2026
- First submitted
- 3 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Data will be analyzed and reported only in aggregate form in scientific publications, including baseline characteristics and study outcomes
Publications
Sahni K, Sanyal B, Agrawal MS, Pant GC, Khanna NN, Khanna S. Carcinoma of breast associated with pregnancy and lactation. J Surg Oncol. 1981;16(2):167-73. doi: 10.1002/jso.2930160208.
PubMed 7464155Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021 Oct;55(19):1106-1118. doi: 10.1136/bjsports-2019-101970. Epub 2021 Mar 30.
PubMed 33785535Alam M, Warycha M. Complications of lasers and light treatments. Dermatol Ther. 2011 Nov-Dec;24(6):571-80. doi: 10.1111/j.1529-8019.2012.01476.x.
PubMed 22515672Ermutlu C, Aksakal M, Gumustas A, Ozkaya G, Kovalak E, Ozkan Y. Thickness of plantar fascia is not predictive of functional outcome in plantar fasciitis treatment. Acta Orthop Traumatol Turc. 2018 Nov;52(6):442-446. doi: 10.1016/j.aott.2018.01.002. Epub 2018 Oct 9.
PubMed 30314878Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011 Aug;94(8):952-7.
PubMed 21863677Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382Keskula DR, Tamburello M. Conservative management of piriformis syndrome. J Athl Train. 1992;27(2):102-10.
PubMed 16558144Naruseviciute D, Kubilius R. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial. Clin Rehabil. 2020 Aug;34(8):1072-1082. doi: 10.1177/0269215520929073. Epub 2020 Jun 8.
PubMed 32513018Gollwitzer H, Diehl P, von Korff A, Rahlfs VW, Gerdesmeyer L. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device. J Foot Ankle Surg. 2007 Sep-Oct;46(5):348-57. doi: 10.1053/j.jfas.2007.05.011.
PubMed 17761319Huffer D, Hing W, Newton R, Clair M. Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. Phys Ther Sport. 2017 Mar;24:44-52. doi: 10.1016/j.ptsp.2016.08.008. Epub 2016 Aug 18.
PubMed 27692740Porter D, Barrill E, Oneacre K, May BD. The effects of duration and frequency of Achilles tendon stretching on dorsiflexion and outcome in painful heel syndrome: a randomized, blinded, control study. Foot Ankle Int. 2002 Jul;23(7):619-24. doi: 10.1177/107110070202300706.
PubMed 12146772Petraglia F, Ramazzina I, Costantino C. Plantar fasciitis in athletes: diagnostic and treatment strategies. A systematic review. Muscles Ligaments Tendons J. 2017 May 10;7(1):107-118. doi: 10.11138/mltj/2017.7.1.107. eCollection 2017 Jan-Mar.
PubMed 28717618Zare Bidoki M, Vafaeei Nasab MR, Khatibi Aghda A. Comparison of High-intensity Laser Therapy with Extracorporeal Shock Wave Therapy in the Treatment of Patients with Plantar Fasciitis: A Double-blind Randomized Clinical Trial. Iran J Med Sci. 2024 Mar 1;49(3):147-155. doi: 10.30476/IJMS.2023.98042.2991. eCollection 2024 Mar.
PubMed 38584653Thammajaree C, Theapthong M, Palee P, Pakpakorn P, Sitti T, Sakulsriprasert P, Bunprajun T, Thong-On S. Effects of radial extracorporeal shockwave therapy versus high intensity laser therapy in individuals with plantar fasciitis: A randomised clinical trial. Lasers Med Sci. 2023 May 23;38(1):127. doi: 10.1007/s10103-023-03791-5.
PubMed 37219650Ordahan B, Karahan AY, Kaydok E. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: a randomized clinical trial. Lasers Med Sci. 2018 Aug;33(6):1363-1369. doi: 10.1007/s10103-018-2497-6. Epub 2018 Apr 7.
PubMed 29627888
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Efficacy Between High-intensity Laser Therapy and Focused Extracorporeal Shock Wave Therapy in Patient With Plantar Fasciitis; Single Blinded Randomize Controlled Study
- ClinicalTrials.gov ID
- NCT07287046
- Acronym / sponsor ID
- HILT / MURA2025/885
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the efficacy of High-Intensity Laser Therapy (HILT) and Focused Extracorporeal Shock Wave Therapy (fESWT) in reducing pain in patients with plantar fasciitis. The study also examines the effects of HILT and fESWT on health-related outcomes, including VAS-FA, FFI, plantar fascia thickness, and adverse events.
Researchers will compare HILT with fESWT as treatment options for patients with plantar fasciitis.
Participants will receive either HILT or fESWT along with an exercise program. They will attend follow-up visits to assess outcomes at 1, 2, 3, 6, and 12 weeks after the first treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT group | Experimental | Device: High power Laser therapyHigh-power laser therapy (iLUX® XP) was applied using a power output of 6 W, an energy density of 5 J/cm², and a spot size of 10 cm², delivering a total energy of 150 J per session. Treatment consisted of 6 sessions, administered twice per week for 3 weeks. |
| fESWT group | Active comparator | Device: Focused extracorporeal shock wave therapyFocused extracorporeal shock wave therapy (fESWT) using the DUOLITH® SD1 (STORZ Medical) was applied at a frequency of 4 Hz, starting at an energy flux density of 0.2 mJ/mm² and gradually increased as tolerated. Each session consisted of 2,000 shocks, for a total of 3 sessions (one session per week) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-70 years
- Pain was worse in the initial step after and an extended period of rest
- Pain was decreased initially after the first steps but exacerbated with increased activity
- VAS ≥ 4
- Pain was localized and sharp but not radiating,
Key exclusion criteria (5 listed)
- Have Wound/Infection/tumor in treatment area
- History of foot trauma in 3 months
- History of intervention at plantar fascia in 6 months such as Ultrasound therapy, steroid injection, surgery or botulinum toxin injection
- Pain medication within one week before participation
- Patient wasn't desired to participate in the study
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 |
|---|---|---|
| High power Laser therapyHigh-power laser therapy (iLUX® XP) was applied using a power output of 6 W, an energy density of 5 J/cm², and a spot size of 10 cm², delivering a total energy of 150 J per session. Treatment consisted of 6 sessions, administered twice per week for 3 weeks | Device | HILT group |
| Focused extracorporeal shock wave therapyFocused extracorporeal shock wave therapy (fESWT) using the DUOLITH® SD1 (STORZ Medical) was applied at a frequency of 4 Hz, starting at an energy flux density of 0.2 mJ/mm² and gradually increased as tolerated. Each session consisted of 2,000 shocks, for a total of 3 sessions (one session per week) | Device | fESWT group |
Primary outcome
Visual analog scale (VAS)
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm) Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain
4 secondary outcomes
VAS-FA Thai version
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Foot function index Thai version
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Thickness of plantar fasciitis
Time frame: Pre-treatment, and 12-week post-treatment
Adverse events
Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 7464155Sahni K, Sanyal B, Agrawal MS, Pant GC, Khanna NN, Khanna S. Carcinoma of breast associated with pregnancy and lactation. J Surg Oncol. 1981;16(2):167-73. doi: 10.1002/jso.2930160208.
- Results publication: PubMed 33785535Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021 Oct;55(19):1106-1118. doi: 10.1136/bjsports-2019-101970. Epub 2021 Mar 30.
- Results publication: PubMed 22515672Alam M, Warycha M. Complications of lasers and light treatments. Dermatol Ther. 2011 Nov-Dec;24(6):571-80. doi: 10.1111/j.1529-8019.2012.01476.x.
- Results publication: PubMed 30314878Ermutlu C, Aksakal M, Gumustas A, Ozkaya G, Kovalak E, Ozkan Y. Thickness of plantar fascia is not predictive of functional outcome in plantar fasciitis treatment. Acta Orthop Traumatol Turc. 2018 Nov;52(6):442-446. doi: 10.1016/j.aott.2018.01.002. Epub 2018 Oct 9.
- Results publication: PubMed 21863677Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011 Aug;94(8):952-7.
- Results publication: PubMed 30211382Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Results publication: PubMed 16558144Keskula DR, Tamburello M. Conservative management of piriformis syndrome. J Athl Train. 1992;27(2):102-10.
- Results publication: PubMed 32513018Naruseviciute D, Kubilius R. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial. Clin Rehabil. 2020 Aug;34(8):1072-1082. doi: 10.1177/0269215520929073. Epub 2020 Jun 8.
- Results publication: PubMed 17761319Gollwitzer H, Diehl P, von Korff A, Rahlfs VW, Gerdesmeyer L. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device. J Foot Ankle Surg. 2007 Sep-Oct;46(5):348-57. doi: 10.1053/j.jfas.2007.05.011.
- Results publication: PubMed 27692740Huffer D, Hing W, Newton R, Clair M. Strength training for plantar fasciitis and the intrinsic foot musculature: A systematic review. Phys Ther Sport. 2017 Mar;24:44-52. doi: 10.1016/j.ptsp.2016.08.008. Epub 2016 Aug 18.
- Results publication: PubMed 12146772Porter D, Barrill E, Oneacre K, May BD. The effects of duration and frequency of Achilles tendon stretching on dorsiflexion and outcome in painful heel syndrome: a randomized, blinded, control study. Foot Ankle Int. 2002 Jul;23(7):619-24. doi: 10.1177/107110070202300706.
- Results publication: PubMed 28717618Petraglia F, Ramazzina I, Costantino C. Plantar fasciitis in athletes: diagnostic and treatment strategies. A systematic review. Muscles Ligaments Tendons J. 2017 May 10;7(1):107-118. doi: 10.11138/mltj/2017.7.1.107. eCollection 2017 Jan-Mar.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Data will be analyzed and reported only in aggregate form in scientific publications, including baseline characteristics and study outcomes
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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.
Suttinon Jitjai, Dortor of Medicine contact
Questions about this trial
What is this clinical trial studying?
A study testing High power Laser therapy and Focused extracorporeal shock wave therapy in people with Plantar Fasciitis, run by Mahidol University.
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 5 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peerada Eurcherdkul, Doctor of Medicine (+6692-272-0652, eurpeerada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment). 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 NCT07287046, which also lists 26 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 25 Mar 2026.