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| ID | Type | Description | Link |
|---|---|---|---|
| Ramathibodi Hospital | Other Identifier | Ramathibodi Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment |
| Foot function index Thai version |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peerada Eurcherdkul, Doctor of Medicine | Contact | +6692-272-0652 | eurpeerada@gmail.com | |
| Suttinon Jitjai, Dortor of Medicine | Contact | +89-463-3401 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7464155 | Result | 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. | |
| 33785535 | 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. |
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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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|
| 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) |
|
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. |
| 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. | Pre-treatment, and 12-week post-treatment |
| Adverse events | Including post-treatment soreness, burns, a burning sensation, and hematoma | Pre-treatment, and at 1-, 2-, 3-, 6-, and 12-week post-treatment |
| 22515672 | 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. |
| 30314878 | 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. |
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| 32513018 | 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. |
| 17761319 | 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. |
| 27692740 | 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. |
| 12146772 | 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. |
| 28717618 | 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. |
| 38584653 | 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. |
| 37219650 | 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. |
| 29627888 | 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. |
| 31871379 | 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. |
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| 34654554 | 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. |
| 28890412 | 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. |
| 19601786 | 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. |
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| 31918529 | 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. |
| 12879710 | 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. |
| 25429080 | 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. |
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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