Genç Ahmet Serhat, Yılmaz Ali Kerim, Anıl Berna, Korkmaz Salkılıç Esra, Akdemir Enes, Güzel Berna, Mor Ahmet, Yarar Hacı Ahmet, Güzel Nizamettin, Kehribar Lokman
Department of Orthopedics and Traumatology, Samsun Education and Research Hospital, Samsun, 55090, Turkey.
Faculty of Yaşar Doğu Sport Sciences, Ondokuz Mayıs University, Samsun, 55270, Turkey.
BMC Musculoskelet Disord. 2025 Jan 4;26(1):17. doi: 10.1186/s12891-024-08244-w.
Menisci, one of the most important anatomical structures of the knee joint, plays a role in load transfer, stability, shock absorption, prevention of articular cartilage degeneration, and proprioception. Type I collagen, the main component of the meniscus, and type II collagen fibers play an important role in the stability of the knee joint. This study aimed to evaluate the effects of Naturagen® 4 Joint product containing type I, II, and III collagen on pain, quality of life, and physical functions in patients with meniscopathy.
This randomized, double-blind, placebo-controlled clinical study included 32 patients (collagen = 17 and placebo = 15) with meniscopathy. Patients completed the Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthrtis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Oxford Knee Score (OKS), Tampa Scale for Kinesiophobia (TSK), Short Form Health Survey (SF-12), Lower Extremity Functional Scale (LEFS), Foot Function Index (FFI), proprioceptive sensation, Timed Up and Go (TUG), 6-Minute Walking Test (6MWT), The Five Repetition Sit to Stand Test (5STS), Stair Climbing Test (SCT), Berg Balance Scale (BBS) and back and leg strength tests and scales were applied. All tests were repeated before and after eight weeks of collagen supplementation.
The study showed that eight weeks of supplementation with various collagen types had statistically significant effects on pain, quality of life, kinesiophobia, and foot function scale scores in patients with meniscopathy (p < 0.05). Similarly, eight weeks of supplementation showed a statistically significant difference in leg strength (p = 0.057), but no significant difference was found in back strength, proprioception, balance, and various functional test results (p > 0.05).
The results of the study showed that the eight-week collagen-based supplement had a positive effect on pain and quality of life levels and some functional test results in patients with meniscopathy. Longer-term studies and diversification of subject groups will help to understand better the effects of the product on meniscal tears and symptoms.
The study was retrospectively registered in the Iranian Clinical Trials Registry on 14/05/2024 with the number IRCT20240411061470N2.
半月板是膝关节最重要的解剖结构之一,在负荷传递、稳定性、减震、预防关节软骨退变和本体感觉方面发挥作用。半月板的主要成分I型胶原蛋白和II型胶原纤维在膝关节稳定性中起重要作用。本研究旨在评估含有I型、II型和III型胶原蛋白的Naturagen® 4关节产品对半月板病变患者疼痛、生活质量和身体功能的影响。
这项随机、双盲、安慰剂对照的临床研究纳入了32例半月板病变患者(胶原蛋白组 = 17例,安慰剂组 = 15例)。患者完成了视觉模拟量表(VAS)、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)、膝关节损伤和骨关节炎结局评分身体功能简表(KOOS-PS)、牛津膝关节评分(OKS)、坦帕运动恐惧量表(TSK)、简短健康调查问卷(SF-12)、下肢功能量表(LEFS)、足部功能指数(FFI)、本体感觉、计时起立行走测试(TUG)、6分钟步行测试(6MWT)、五次坐立试验(5STS)、爬楼梯测试(SCT)、伯格平衡量表(BBS)以及背部和腿部力量测试及量表。在补充胶原蛋白八周前后均重复进行所有测试。
研究表明,对半月板病变患者补充各种类型的胶原蛋白八周,在疼痛、生活质量、运动恐惧和足部功能量表评分方面具有统计学显著效果(p < 0.05)。同样,补充八周在腿部力量方面显示出统计学显著差异(p = 0.057),但在背部力量、本体感觉、平衡和各种功能测试结果方面未发现显著差异(p > 0.05)。
研究结果表明,为期八周的基于胶原蛋白的补充剂对半月板病变患者的疼痛和生活质量水平以及一些功能测试结果有积极影响。长期研究和受试者群体的多样化将有助于更好地了解该产品对半月板撕裂和症状的影响。
该研究于2024年5月14日在伊朗临床试验注册中心进行回顾性注册,注册号为IRCT20240411061470N2。