School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.
La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.
Cochrane Database Syst Rev. 2024 Jun 17;6(6):CD007809. doi: 10.1002/14651858.CD007809.pub3.
BACKGROUND: Osteoarthritis (OA) affecting the first metatarsophalangeal joint (hallux rigidus) is common and painful. Several non-surgical treatments have been proposed; however, few have been adequately evaluated. Since the original 2010 review, several studies have been published necessitating this update. OBJECTIVES: To determine the benefits and harms of non-surgical treatments for big toe OA. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was February 2023. SELECTION CRITERIA: We included randomised trials that compared any type of non-surgical treatment versus placebo (or sham), no treatment (such as wait-and-see) or other treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. The major outcomes were pain, function, quality of life, radiographic joint structure, adverse events and withdrawals due to adverse events. The primary time point was 12 weeks. We used GRADE to assess the certainty of evidence. MAIN RESULTS: This update includes six trials (547 participants). The mean age of participants ranged from 32 to 62 years. Trial durations ranged from 4 to 52 weeks. Treatments were compared in single trials as follows: arch-contouring foot orthoses versus sham inserts; shoe-stiffening inserts versus sham inserts; intra-articular injection of hyaluronic acid versus saline (placebo) injection; arch-contouring foot orthoses versus rocker-sole footwear; peloid therapy versus paraffin therapy; and sesamoid mobilisation, flexor hallucis longus strengthening and gait training plus physical therapy versus physical therapy alone. Certainty of the evidence was limited by the risk of bias and imprecision. Meta-analysis was not performed due to the heterogeneity of interventions. We reported numerical data for the 12-week time point for the three trials that used a placebo/sham control group. Arch-contouring foot orthoses versus sham inserts One trial (88 participants) showed that arch-contouring foot orthoses probably lead to little or no difference in pain, function, or quality of life compared to sham inserts (moderate certainty). Mean pain (0-10 scale, 0 no pain) with sham inserts was 3.9 points compared to 3.5 points with arch-contouring foot orthoses; a difference of 0.4 points better (95% (CI) 0.5 worse to 1.3 better). Mean function (0-100 scale, 100 best function) with sham inserts was 73.3 points compared to 65.5 points with arch-contouring foot orthoses; a difference of 7.8 points worse (95% CI 17.8 worse to 2.2 better). Mean quality of life (-0.04-100 scale, 100 best score) with sham inserts was 0.8 points compared to 0.8 points with arch-contouring foot orthoses group (95% CI 0.1 worse to 0.1 better). Arch-contouring foot orthoses may show little or no difference in adverse events and withdrawal due to adverse events compared to sham inserts (low certainty). Adverse events (mostly foot pain) were reported in 6 out of 41 people with sham inserts and 4 out of 47 people with arch-contouring foot orthoses (RR 0.58, 95% CI 0.18 to 1.92). Withdrawals due to adverse events were reported in 0 out of 41 people with sham inserts and 1 out of 47 people with arch-contouring foot orthoses (Peto OR 6.58, 95% CI 0.13 to 331). Shoe-stiffening inserts versus sham inserts One trial (100 participants) showed that shoe-stiffening inserts probably lead to little or no difference in pain, function, or quality of life when compared to sham inserts (moderate certainty). Mean pain (0-100 scale, 0 no pain) with sham inserts was 63.8 points compared to 70.1 points with shoe-stiffening inserts; a difference of 6.3 points better (95% CI 0.5 worse to 13.1 better). Mean function (0-100 scale, 100 best function) with sham inserts was 81.0 points compared to 84.9 points with shoe-stiffening inserts; a difference of 3.9 points better (95% CI 3.3 worse to 11.1 better). Mean quality of life (0-100 scale, 100 best score) with sham inserts was 53.2 points compared to 53.3 points with shoe-stiffening inserts; a difference of 0.1 points better (95% CI 3.7 worse to 3.9 better). Shoe-stiffening inserts probably show little or no difference in adverse events (moderate-certainty) and may show little or no difference in withdrawal due to adverse events (low-certainty), compared to sham inserts. Adverse events (mostly foot pain, blisters, and spine/hip pain) were reported in 31 out of 51 people with sham inserts and 29 out of 49 people with shoe-stiffening inserts (RR 0.94, 95% CI 0.42 to 2.08). Withdrawals due to adverse events were reported in 1 out of 51 people with sham inserts and 2 out of 49 people with shoe-stiffening inserts (Peto OR 2.08, 95% CI 0.19 to 22.23). Hyaluronic acid versus placebo One trial (151 participants) showed that a single intra-articular injection of hyaluronic acid probably leads to little or no difference in pain or function compared to placebo (moderate certainty). Mean pain (0-100 scale, 0 no pain) with placebo was 72.5 points compared to 68.2 points with hyaluronic acid; a difference of 4.3 points better (95% CI 2.1 worse to 10.7 better). Mean function (0-100 scale, 100 best function) was 83.4 points with placebo compared to 85.0 points with hyaluronic acid; a difference of 1.6 points better (95% CI 4.6 worse to 7.8 better). Hyaluronic acid may provide little or no difference in quality of life (0-100 scale, 100 best score) which was 79.9 points with placebo compared to 82.9 points with hyaluronic acid; a difference of 3.0 better (95% CI 1.4 worse to 7.4 better; low certainty). There may be fewer adverse events with hyaluronic acid compared to placebo. Adverse events (mostly pain at the injection site) were reported in 43 out of 76 people with placebo compared with 27 out of 75 people with hyaluronic acid (RR 0.64, 95% CI 0.44 to 0.91; low certainty). No participants withdrew from either group due to adverse events. The effects on radiographic joint structure were not reported in any study. AUTHORS' CONCLUSIONS: The existing evidence regarding the benefits and harms of non-surgical treatments for big toe OA is limited. There is moderate-certainty evidence, based upon three single placebo/sham-controlled trials, that there are no clinically important benefits of arch-contouring foot orthoses, shoe-stiffening inserts, or a single intra-articular injection of hyaluronic acid. Further placebo-controlled trials are needed to evaluate the effectiveness of non-surgical treatments for big toe OA.
背景:影响第一跖趾关节(拇僵硬)的骨关节炎(OA)很常见且疼痛。已经提出了几种非手术治疗方法;然而,很少有研究进行充分评估。自最初的 2010 年审查以来,已经发表了几项研究,因此需要更新。
目的:确定拇 OA 的非手术治疗的益处和危害。
检索方法:我们使用了标准的、广泛的 Cochrane 检索方法。最新的检索是在 2023 年 2 月。
选择标准:我们纳入了比较任何类型的非手术治疗与安慰剂(或假对照)、无治疗(如观察等待)或其他治疗的随机试验。
数据收集和分析:我们使用了标准的 Cochrane 方法。主要结局是疼痛、功能、生活质量、关节结构的放射学表现、不良事件和因不良事件而退出的情况。主要时间点是 12 周。我们使用 GRADE 评估证据的确定性。
主要结果:本次更新包括六项试验(547 名参与者)。参与者的平均年龄从 32 岁到 62 岁不等。试验持续时间从 4 周到 52 周不等。在单一试验中比较了以下治疗方法:足弓成形矫形器与假插入物;鞋跟加固插入物与假插入物;关节内注射透明质酸与生理盐水(安慰剂)注射;足弓成形矫形器与摇摆鞋底鞋;泥疗法与石蜡疗法;以及籽骨松动、跖屈肌强化和步态训练加物理治疗与单独物理治疗。由于偏倚和不精确性,证据的确定性有限。由于干预措施的异质性,未进行荟萃分析。我们报告了三个使用安慰剂/假对照的试验的 12 周时间点的数值数据。
足弓成形矫形器与假插入物:一项试验(88 名参与者)表明,与假插入物相比,足弓成形矫形器可能导致疼痛、功能或生活质量几乎没有或没有差异(中度确定性)。使用假插入物的疼痛(0-10 刻度,0 无疼痛)为 3.9 分,而使用足弓成形矫形器的疼痛为 3.5 分;更好的差异为 0.4 分(95%CI 0.5 更差至 1.3 更好)。使用假插入物的功能(0-100 刻度,100 最佳功能)为 73.3 分,而使用足弓成形矫形器的功能为 65.5 分;更差的差异为 7.8 分(95%CI 17.8 更差至 2.2 更好)。使用假插入物的生活质量(-0.04-100 刻度,100 最佳评分)为 0.8 分,而使用足弓成形矫形器的生活质量为 0.8 分(95%CI 0.1 更差至 0.1 更好)。与假插入物相比,足弓成形矫形器可能在不良事件和因不良事件而退出方面几乎没有或没有差异(低确定性)。报告了 6 名假插入物和 4 名足弓成形矫形器参与者出现不良事件(主要是足部疼痛)(RR 0.58,95%CI 0.18 至 1.92)。因不良事件退出的有 0 人接受假插入物和 1 人接受足弓成形矫形器(Peto OR 6.58,95%CI 0.13 至 331)。
鞋跟加固插入物与假插入物:一项试验(100 名参与者)表明,与假插入物相比,鞋跟加固插入物可能在疼痛、功能或生活质量方面几乎没有或没有差异(中度确定性)。使用假插入物的疼痛(0-100 刻度,0 无疼痛)为 63.8 分,而使用鞋跟加固插入物的疼痛为 70.1 分;更好的差异为 6.3 分(95%CI 0.5 更差至 13.1 更好)。使用假插入物的功能(0-100 刻度,100 最佳功能)为 81.0 分,而使用鞋跟加固插入物的功能为 84.9 分;更好的差异为 3.9 分(95%CI 3.3 更差至 11.1 更好)。使用假插入物的生活质量(0-100 刻度,100 最佳评分)为 53.2 分,而使用鞋跟加固插入物的生活质量为 53.3 分;更好的差异为 0.1 分(95%CI 3.7 更差至 3.9 更好)。与假插入物相比,鞋跟加固插入物可能在不良事件方面几乎没有或没有差异(中度确定性),并且可能在因不良事件而退出方面几乎没有或没有差异(低确定性)。报告了 31 名假插入物和 29 名鞋跟加固插入物参与者出现不良事件(主要是足部疼痛、水疱和脊柱/髋部疼痛)(RR 0.94,95%CI 0.42 至 2.08)。因不良事件退出的有 1 人接受假插入物和 2 人接受鞋跟加固插入物(Peto OR 2.08,95%CI 0.19 至 22.23)。
透明质酸与安慰剂:一项试验(151 名参与者)表明,单次关节内注射透明质酸与安慰剂相比,可能在疼痛或功能方面几乎没有或没有差异(中度确定性)。使用安慰剂的疼痛(0-100 刻度,0 无疼痛)为 72.5 分,而使用透明质酸的疼痛为 68.2 分;更好的差异为 4.3 分(95%CI 2.1 更差至 10.7 更好)。使用安慰剂的功能(0-100 刻度,100 最佳功能)为 83.4 分,而使用透明质酸的功能为 85.0 分;更好的差异为 1.6 分(95%CI 4.6 更差至 7.8 更好)。透明质酸在生活质量(0-100 刻度,100 最佳评分)方面可能没有差异,使用安慰剂的生活质量为 79.9 分,而使用透明质酸的生活质量为 82.9 分;更好的差异为 3.0 分(95%CI 1.4 更差至 7.4 更好;低确定性)。与安慰剂相比,可能有更少的不良事件。报告了 43 名安慰剂和 27 名透明质酸参与者出现注射部位疼痛等不良事件(RR 0.64,95%CI 0.44 至 0.91;低确定性)。没有参与者因不良事件而退出。
在任何研究中都没有报告对关节结构的放射学影响。
作者结论:关于拇 OA 非手术治疗的益处和危害的现有证据有限。基于三项单独安慰剂/假对照试验,有中度确定性证据表明,足弓成形矫形器、鞋跟加固插入物或单次关节内注射透明质酸没有临床重要的益处。需要进一步的安慰剂对照试验来评估非手术治疗拇僵硬的效果。
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