Consultation pluridisciplinaire de la douleur, Centre de réadaptation fonctionnelle de Lannion-Trestel, Trévou-Tréguignec, France.
Cabinet de chirurgie dentaire, Parc d'activités de Coataner, Douarnenez, France.
BMC Musculoskelet Disord. 2022 Apr 27;23(1):392. doi: 10.1186/s12891-022-05352-3.
Chronic pain and functional impairment interfere with the quality of life of subjects suffering from temporomandibular joint (TMJ) disorders. Intra-articular (IA) hyaluronic acid (HA) injections have been shown to alleviate pain and improve mandibular mobility in patients with TMJ osteoarthritis (OA).
The primary aim of the study was to identify the prognostic factors of patient satisfaction for a single IA injection of a mannitol-modified crosslinked HA (HANOX-M-XL) in patients with TMJ-OA. The second goal was to obtain clinical data on effectiveness, safety and mandibular mobility throughout a six-month follow-up period.
This was an observational single-arm prospective trial with a six-month follow-up.
patients with TMJ-OA which is not relieved by analgesics and/or non-steroidal-anti-inflammatory drugs and/or orthotics, with radiological evidence of TMJ-OA. All patients received a single IA injection of 1 ml HANOX-M-XL in the target TMJ. The primary endpoint was patient satisfaction on day 180. The main secondary outcome measures were pain variation on a 11-point numeric scale (0-11) between the date of injection and month six, the variation over time of the Maximum Inter-Incisal Opening Distance (MIIOD) and the patient's assessment of effectiveness. Predictive factors of success or failure were also studied. All adverse events were recorded.
36 subjects (mean age 55.3 years, mean disease duration 98 months), covering a total of 52 injected TMJs, were included. Between baseline and endpoint, the average pain while chewing decreased dramatically from 6.9 ± 1.2 to 2.9 ± 1.3 (p < 0.0001) and the MIIOD increased from 29 ± 7 to 35 ± 5 mm (p < 0.01). On day 180, all patients were satisfied with the treatment, with 34 patients (94%) rating it as highly effective or effective. Tolerability was good in all but one patient. In the multivariate analysis, patient satisfaction on day 180 was highly correlated with the pain while chewing score, pain on palpation score and the decrease of pain over time (all p < 0.0001) but not with MIIOD, gender, age, bruxism, articular noise and symptom duration. Previous viscosupplementation was also related to higher satisfaction (p = 0.01).
Despite a long history of pain, most of the patients with symptomatic TMJ-OA benefited from a single injection of HANOX-M-XL, as shown by the sustained (up to 6 months) decrease in pain and improvement in mandibular mobility, with no safety concerns.
慢性疼痛和功能障碍会干扰患有颞下颌关节（TMJ）紊乱的患者的生活质量。关节内（IA）透明质酸（HA）注射已被证明可减轻 TMJ 骨关节炎（OA）患者的疼痛并改善下颌运动。
本研究的主要目的是确定 Mannitol 修饰的交联 HA（HANOX-M-XL）单次 IA 注射治疗 TMJ-OA 患者的患者满意度的预测因素。第二个目标是在六个月的随访期间获得关于有效性、安全性和下颌运动的临床数据。
这是一项具有六个月随访的观察性单臂前瞻性试验。
对镇痛药和/或非甾体抗炎药和/或矫形器无缓解的 TMJ-OA 患者，有 TMJ-OA 的放射学证据。所有患者均接受 1ml HANOX-M-XL 在目标 TMJ 中的单次 IA 注射。主要终点是第 180 天的患者满意度。主要次要结局指标为注射日期和第六个月之间 11 点数字量表（0-11）上的疼痛变化、最大开口距离（MIIOD）的随时间变化以及患者对有效性的评估。还研究了成功或失败的预测因素。记录所有不良事件。
36 名患者（平均年龄 55.3 岁，平均病程 98 个月），共涉及 52 个注射 TMJ，被纳入。与基线相比，在终点时，咀嚼时的平均疼痛从 6.9±1.2 显著降低至 2.9±1.3（p<0.0001），最大开口距离从 29±7 增加至 35±5mm（p<0.01）。第 180 天，所有患者均对治疗满意，34 名患者（94%）认为治疗非常有效或有效。除一名患者外，所有患者均耐受良好。在多变量分析中，第 180 天的患者满意度与咀嚼时的疼痛评分、触诊时的疼痛评分和疼痛随时间的下降高度相关（均 p<0.0001），但与 MIIOD、性别、年龄、磨牙症、关节噪音和症状持续时间无关。先前的粘性补充剂也与更高的满意度相关（p=0.01）。
尽管有长期疼痛史，但大多数患有症状性 TMJ-OA 的患者从 HANOX-M-XL 单次注射中受益，表现为疼痛持续（长达 6 个月）减轻和下颌运动改善，无安全性问题。
