Shock Waves in Knee Arthritis

Официальное название

Extracorporeal Shock Wave Therapy in Patients With Knee Arthritis

Обзор

Pathological arthritis is a degenerative disease affecting the joints, characterized by pain, limitation of movement up to ankylosis and disability. Treatment is aimed at reducing pain and slowing the loss of functionality of the district. Among conservative treatments, pharmacological options (NSAIDs, cortisone, contrasupplements, hyaluronic acid) and non-pharmacological options (therapeutic exercise, physical therapy, orthosis, etc.) are indicated. In cases not responding to conservative treatments, surgical treatment will be necessary with prosthetic replacement of the joint district.

Подробное описание

In recent years, shock wave therapy has received a lot of interest in the treatment of numerous musculoskeletal pathologies. This physical therapy exploits the cavitational effect induced on the tissues which translates into neo-angiogenic, anti-inflammatory, regenerative and analgesic action. Until now, the indication has been reserved for the treatment of tendinopathies and delayed consolidation of fractures. Pre-clinical research is also paving the way for the treatment of cartilage pathologies; in fact, after the stimulation of the chondrocyte, a modulation of the phlogogenic cytokines has been found, supporting a slowing down of the progression of the arthritic pathology. The first clinical experiences on arthritic models, such as rhizarthrosis, allow to support the indication also on the pathological model of gonarthrosis. The aim of this study is to verify the effects of shock wave therapy in the patient affected by gonarthrosis, monitoring the action on pain, functionality and tissue district changes.

Вмешательства

• Устройство ESWT group
  During each session, participants will receive 2000 pulses at a frequency of 4 Hz and an EDF between 0.02 and 0.2 mJ/mm2.
• Другое exercise group
  daily exercise program

Первичные конечные точки

• recovery of pain [Срок оценки: From enrollment to 1, 3 and 6 months]
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Срок оценки: From enrollment to 1, 3 and 6 months]

Вторичные конечные точки (2)

• Roles and Maudsley Score [Срок оценки: At 1, 3 and 6 months]
• MR image [Срок оценки: From enrollment to 6 months]

Критерии участия

Критерии включения

• persistent knee pain for at least 3 months, measured with a VAS scale of 4 or higher,
• clinical and radiological diagnosis confirming knee osteoarthritis grade 2 and 3 based on the Kellgren-Lawrence system,
• no history of physical therapy in the last 3 months,
• no infections, tumors in the treatment area of the knee,
• no pathology other than osteoarthritis that could cause knee pain,
• no pathology of the lumbar spine or hip that could refer knee pain,
• free from any condition that prevents participation in exercise or physical therapy willing to participate regularly in the treatment programs were included in the study.

Критерии исключения

• inability to walk,
• a history of clinically symptomatic spinal stenosis or lumbar radiculopathy,
• evidence of a neurological disorder based on history or physical examination,
• generalized pain or fibromyalgia,
• secondary osteoarthritis (to metabolic or rheumatologic disease),
• administration of intra-articular injections (anesthetic, hyaluronic acid, cortisone) of the knee in the last 6 months,
• use of NSAIDs, paracetamol or topical agents in the previous week,
• a previous history of surgery involving the knee joint,
• contraindications to physical therapy (PM, epilepsy, neoplasia, coagulopathy, pregnancy).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Policlinico di Bari — Bari

Публикации

• Zhao Z, Ji H, Jing R, Liu C, Wang M, Zhai L, Bai X, Xing G. Extracorporeal shock-wave therapy reduces progression of knee osteoarthritis in rabbits by reducing nitric oxide level and chondrocyte apoptosis. Arch Orthop Trauma Surg. 2012 Nov;132(11):1547-53. doi: 10.1007/s00402-012-1586-4. Epub 2012 Jul 24. PMID 22825641
• Ochiai N, Ohtori S, Sasho T, Nakagawa K, Takahashi K, Takahashi N, Murata R, Takahashi K, Moriya H, Wada Y, Saisu T. Extracorporeal shock wave therapy improves motor dysfunction and pain originating from knee osteoarthritis in rats. Osteoarthritis Cartilage. 2007 Sep;15(9):1093-6. doi: 10.1016/j.joca.2007.03.011. Epub 2007 Apr 26. PMID 17466542
• Mostafa MSEM, Hamada HA, Kadry AM, Zahran SS, Helmy NA. Effect of High-Power Laser Therapy Versus Shock Wave Therapy on Pain and Function in Knee Osteoarthritis Patients: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Mar;40(3):198-204. doi: 10.1089/photob.2021.0136. Epub 2022 Jan 5. PMID 34986012

Идентификаторы

NCT: NCT06833372 · SWinKA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗