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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High power Laser therapy, Focused extracorporeal shock wave therapy.
- Who it may be relevant to
- Registry conditions: Plantar Fasciitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device High power Laser therapy
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 Focused extracorporeal shock wave therapy
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)
Primary outcome measures
- Visual analog scale (VAS) [Time frame: Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 7464155
- 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
- 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
- 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
- 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
- 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
- Keskula DR, Tamburello M. Conservative management of piriformis syndrome. J Athl Train. 1992;27(2):102-10. PMID 16558144
- 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
Identifiers
NCT: NCT07287046 · MURA2025/885 · Ramathibodi Hospital