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

NCT07287046 | Not Yet Recruiting

• 2 other identifiers: MURA2025/885Ramathibodi Hospital
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment

Secondary Outcomes (4)

• VAS-FA Thai version

  Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment

• Foot function index Thai version

  Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment

• Thickness of plantar fasciitis

  Pre-treatment, and 12-week post-treatment

• Adverse events

  Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment

Study Arms (2)

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.

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)

Device: Focused extracorporeal shock wave therapy

Interventions

High power Laser therapy DEVICE

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

HILT group

Focused extracorporeal shock wave therapy DEVICE

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)

fESWT group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (26)

• 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.

  PMID: 7464155 RESULT

• Morrissey 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.

  PMID: 33785535 RESULT

• Alam 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.

  PMID: 22515672 RESULT

• Ermutlu 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.

  PMID: 30314878 RESULT

• Angthong 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.

  PMID: 21863677 RESULT

• Delgado 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.

  PMID: 30211382 RESULT

• Keskula DR, Tamburello M. Conservative management of piriformis syndrome. J Athl Train. 1992;27(2):102-10.

  PMID: 16558144 RESULT

• Naruseviciute 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.

  PMID: 32513018 RESULT

• Gollwitzer 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.

  PMID: 17761319 RESULT

• Huffer 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.

  PMID: 27692740 RESULT

• Porter 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.

  PMID: 12146772 RESULT

• Petraglia 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.

  PMID: 28717618 RESULT

• Zare 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.

  PMID: 38584653 RESULT

• Thammajaree 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.

  PMID: 37219650 RESULT

• Ordahan 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.

  PMID: 29627888 RESULT

• Ebid AA, Alhammad RM, Alhendi RT, Alqarhi BA, Baweyan EM, Alfadli LH, Alzahrani MA, Alotaibi MF, Alaidrous NA, Alzahrani RA, Alqurashi RM, Alharbi SS, Azhar SJ. Immediate effect of pulsed high-intensity neodymium-doped yttrium aluminum garnet (Nd: YAG) laser on staphylococcus aureus and pseudomonas aeruginosa growth: an experimental study. J Phys Ther Sci. 2019 Nov;31(11):925-930. doi: 10.1589/jpts.31.925. Epub 2019 Nov 26.

  PMID: 31871379 RESULT

• Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.

  PMID: 25653800 RESULT

• Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.

  PMID: 34654554 RESULT

• Roerdink RL, Dietvorst M, van der Zwaard B, van der Worp H, Zwerver J. Complications of extracorporeal shockwave therapy in plantar fasciitis: Systematic review. Int J Surg. 2017 Oct;46:133-145. doi: 10.1016/j.ijsu.2017.08.587. Epub 2017 Sep 7.

  PMID: 28890412 RESULT

• Mariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. doi: 10.2174/092986709788682119.

  PMID: 19601786 RESULT

• Lohrer H, Nauck T, Dorn-Lange NV, Scholl J, Vester JC. Comparison of radial versus focused extracorporeal shock waves in plantar fasciitis using functional measures. Foot Ankle Int. 2010 Jan;31(1):1-9. doi: 10.3113/FAI.2010.0001.

  PMID: 20067715 RESULT

• Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.

  PMID: 34038642 RESULT

• Diaz Lopez AM, Guzman Carrasco P. [Effectiveness of different physical therapy in conservative treatment of plantar fasciitis: systematic review]. Rev Esp Salud Publica. 2014 Jan-Feb;88(1):157-78. doi: 10.4321/S1135-57272014000100010. Spanish.

  PMID: 24728397 RESULT

• Thong-On S, Bovonsunthonchai S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Effects of Strengthening and Stretching Exercises on the Temporospatial Gait Parameters in Patients With Plantar Fasciitis: A Randomized Controlled Trial. Ann Rehabil Med. 2019 Dec;43(6):662-676. doi: 10.5535/arm.2019.43.6.662. Epub 2019 Dec 31.

  PMID: 31918529 RESULT

• Jarde O, Diebold P, Havet E, Boulu G, Vernois J. Degenerative lesions of the plantar fascia: surgical treatment by fasciectomy and excision of the heel spur. A report on 38 cases. Acta Orthop Belg. 2003 Jun;69(3):267-74.

  PMID: 12879710 RESULT

• Thompson JV, Saini SS, Reb CW, Daniel JN. Diagnosis and management of plantar fasciitis. J Am Osteopath Assoc. 2014 Dec;114(12):900-6. doi: 10.7556/jaoa.2014.177.

  PMID: 25429080 RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Peerada Eurcherdkul, Doctor of Medicine

CONTACT

+6692-272-0652; eurpeerada@gmail.com

Suttinon Jitjai, Dortor of Medicine

CONTACT

+89-463-3401

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share