Perineural Dextrose Versus Local Anesthetic Injections in Knee Osteoarthritis

Официальное название

A Prospective Evaluation of the Clinical Effectiveness of Perineural Dextrose and Conventional Local Anesthetic Injections in Patients With Symptomatic Knee Osteoarthritis

Обзор

This prospective observational study aims to compare the clinical effectiveness of perineural 5% dextrose injections and perineural local anesthetic injections in patients with symptomatic knee osteoarthritis. Adult patients receiving routine perineural injection therapy will be followed for six months. Pain intensity and functional outcomes will be assessed at baseline and at 1, 3, and 6 months after treatment using validated clinical assessment tools.

Подробное описание

Knee osteoarthritis is a common degenerative joint disease associated with chronic pain, functional limitation, and reduced quality of life. Various non-surgical treatment modalities have been used to manage symptoms; however, the effectiveness of these treatments may be limited due to the complex pain mechanisms involved in osteoarthritis.

Perineural injection therapy has gained increasing attention as a minimally invasive treatment option targeting neurogenic inflammation around peripheral sensory nerves. Perineural 5% dextrose injection is thought to reduce pain by modulating neurogenic inflammation, while local anesthetic injections are commonly used in clinical practice for symptomatic relief.

This study is designed as a prospective observational cohort study conducted in a routine clinical setting. Patients aged 40 to 65 years with symptomatic knee osteoarthritis who are treated with perineural injections as part of standard care will be included. The choice of injectate (perineural 5% dextrose or perineural local anesthetic) will be determined based on clinical considerations and patient preference; no randomization or protocol-driven assignment will be performed.

Pain severity will be evaluated using the Visual Analog Scale (VAS). Functional status will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Additional clinical parameters, including knee range of motion measured by goniometry and quadriceps muscle strength assessed by manual muscle testing, will also be recorded. Assessments will be performed at baseline, and at 1, 3, and 6 months following treatment.

Clinical outcomes of the two treatment groups will be compared to evaluate changes in pain and functional status over time. The findings of this study are expected to contribute real-world evidence regarding the clinical effectiveness of perineural 5% dextrose and local anesthetic injections in the management of symptomatic knee osteoarthritis.

Вмешательства

• Процедура Perineural 5% Dextrose Injection
  Perineural injection of 5% dextrose solution administered around periarticular sensory nerves of the knee as part of routine clinical practice.
• Процедура Perineural Local Anesthetic Injection
  Perineural injection of local anesthetic administered around periarticular sensory nerves of the knee as part of routine clinical practice.

Первичные конечные точки

• Change in Knee Pain Intensity (Visual Analog Scale [VAS]) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]

Вторичные конечные точки (3)

• Change in Functional Status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Knee Range of Motion [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Quadriceps Muscle Strength [Срок оценки: Baseline, 1 month, 3 months, and 6 months]

Критерии участия

Критерии включения

• Symptomatic knee osteoarthritis
• Clinical/radiological diagnosis
• Knee pain ≥ 3 months
• Written informed consent

Критерии исключения

• Prior knee surgery
• Recent intra-articular injection
• Inflammatory rheumatic disease
• Severe systemic or neurological disease
• Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 2 центра

• Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230 — Ankara
• Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230 — Ankara

Публикации

• Pan PJ, Wang JC, Tsai CC, Kuo HC. Identification of early response to hypertonic dextrose prolotherapy markers in knee osteoarthritis patients by an inflammation-related cytokine array. J Chin Med Assoc. 2022 Apr 1;85(4):525-531. doi: 10.1097/JCMA.0000000000000693. PMID 35019866
• Salsabil JR, Pane RV, Hasan H, Al Hajiri AZZ. Hypertonic Dextrose Prolotherapy Injection in Grade IV Knee Osteoarthritis with Obesity: A Case Report. Acta Med Indones. 2024 Jul;56(3):349-355. PMID 39463100
• Huang K, Cai H. Hypertonic dextrose prolotherapy in osteoarthritis: mechanisms, efficacy, and future research directions. Front Endocrinol (Lausanne). 2025 Aug 4;16:1602727. doi: 10.3389/fendo.2025.1602727. eCollection 2025. PMID 40831953
• Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7. PMID 31426856
• Chen YW, Lin YN, Chen HC, Liou TH, Liao CD, Huang SW. Effectiveness, Compliance, and Safety of Dextrose Prolotherapy for Knee Osteoarthritis: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Clin Rehabil. 2022 Jun;36(6):740-752. doi: 10.1177/02692155221086213. Epub 2022 Mar 8. PMID 35257594
• Bae G, Kim S, Lee S, Lee WY, Lim Y. Prolotherapy for the patients with chronic musculoskeletal pain: systematic review and meta-analysis. Anesth Pain Med (Seoul). 2021 Jan;16(1):81-95. doi: 10.17085/apm.20078. Epub 2020 Dec 16. PMID 33348947
• Hung CY, Hsiao MY, Chang KV, Han DS, Wang TG. Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. J Pain Res. 2016 Oct 18;9:847-857. doi: 10.2147/JPR.S118669. eCollection 2016. PMID 27799816
• Jahangiri A, Moghaddam FR, Najafi S. Hypertonic dextrose versus corticosteroid local injection for the treatment of osteoarthritis in the first carpometacarpal joint: a double-blind randomized clinical trial. J Orthop Sci. 2014 Sep;19(5):737-43. doi: 10.1007/s00776-014-0587-2. Epub 2014 Aug 27. PMID 25158896

Идентификаторы

NCT: NCT07381621 · AnkaraTRH-FTR-NK-10 · 2024-KAEK-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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