Plantar Fasciitis Randomized Clinical Control Trial

Официальное название

Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis

Обзор

The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.

Подробное описание

Clinically, proximal PF causes plantar heel pain, which may extend into the proximal portion of the plantar longitudinal arch. Typically, the pain is most notable upon initial weight bearing ambulation (post-static dyskinesia, PSD), such as the first step in the morning or following a period of non-weight bearing or rest. This can be attributed to walking on hard surfaces or barefoot, prolonged weight bearing activity, inadequate stretching and use of poor footwear, as well as increased amounts of walking. Standard treatment of PF includes the use of foot orthotics, both pre-fabricated and custom molded, physical therapy and myotendinous stretching, splinting or strapping the foot, nonsteroidal anti-inflammatory drugs, ice, and corticosteroid injections. Ultrasonography (US) can be useful for examining the plantar fascia, which typically measures between 2 mm to 4 mm in thickness, and findings indicative of PF include diffuse hypoechogenicity at the calcaneal attachment of the plantar fascia, loss of definition between the plantar fascia and the surrounding soft tissues, peri-insertion edema, and thickness over 4.5 mm. Local infiltration of corticosteroids has been used to treat PF since the 1950s. Despite this being a well established treatment, there are still unexamined features of this form of intervention, including the method of injection, type of steroid used, concurrent use of localanesthetic agents, concurrent use of orthoses and/or supportive arch strapping, concurrent physical therapy, and the use of ultrasonographic guidance of the corticosteroid injection. The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.

Вмешательства

• Процедура Local Steroid Injection into the plantar heel
  Injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml.
• Процедура Ultrasound Guided Injection
  Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach
• Процедура Anatomical Guided injection
  Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.

Первичные конечные точки

• Change in VAS pain score at post injection periods with use of USGI [Срок оценки: Baseline to 3 months, 6 month, 9 month, and 12 month follow up]
• Change in VAS pain score at post injection periods with use of ATGI [Срок оценки: Baseline to 3 months, 6 month, 9 month, and 12 month follow up]

Вторичные конечные точки (3)

• Observation of normal plantar fascia after treatment as measured by ultrasound (US) [Срок оценки: Baseline to 12 month follow up]
• Foot-related quality of life outcomes as measured with use of the FFI [Срок оценки: Baseline to 3 months, 6 month, 9 month, and 12 month follow up]
• Foot-related quality of life outcomes as measured with use of the BFS [Срок оценки: Baseline to 3 months, 6 month, 9 month, and 12 month follow up]

Критерии участия

Критерии включения

• Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur
• ≥18 years of age
• Male or non-pregnant female of any ethnicity or race
• Active, former or non smoker
• With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain
• With or without diabetes mellitus without polyneuropathy
• With or without collagen vascular disease without lower extremity wound formation.

Критерии исключения

• Known drug or alcohol dependence
• Chronic pain syndrome or lumbosacral radiculitis
• Neurological condition that requires the use of analgesic medications or anti-seizure or neuroleptic medications
• Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration
• Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically
• Pregnant females
• Known allergy to any of the components of the injection therapy
• Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation
• Existing or prior osteomyelitis of the involved calcaneus
• Unable to consent to participation in clinical research or currently be involved in another clinical investigation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Penn Presbyterian Medical Center — Philadelphia

Публикации

• Ang TW. The effectiveness of corticosteroid injection in the treatment of plantar fasciitis. Singapore Med J. 2015 Aug;56(8):423-32. doi: 10.11622/smedj.2015118. PMID 26311907
• Weil L Jr, Glover JP, Weil LS Sr. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. 2008 Feb;1(1):13-8. doi: 10.1177/1938640007312318.. PMID 19825686
• Young CC, Rutherford DS, Niedfeldt MW. Treatment of plantar fasciitis. Am Fam Physician. 2001 Feb 1;63(3):467-74, 477-8. PMID 11272297
• Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available. PMID 15152061
• Wessel J. The reliability and validity of pain threshold measurements in osteoarthritis of the knee. Scand J Rheumatol. 1995;24(4):238-42. doi: 10.3109/03009749509100881. PMID 7481589
• Lundeberg T, Lund I, Dahlin L, Borg E, Gustafsson C, Sandin L, Rosen A, Kowalski J, Eriksson SV. Reliability and responsiveness of three different pain assessments. J Rehabil Med. 2001 Nov;33(6):279-83. doi: 10.1080/165019701753236473. PMID 11766958
• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x. PMID 11733293
• Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4. PMID 2037861

Идентификаторы

NCT: NCT03231150 · PPMC-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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