Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.
Department of Hand Surgery, Södersjukhuset, Stockholm, Sweden.
Trials. 2024 Nov 26;25(1):797. doi: 10.1186/s13063-024-08636-2.
Osteoarthritis in the thumb base (trapeziometacarpal joint, CMC-1 joint) is prevalent, particularly among middle-aged and elderly women, causing significant disability. Conservative treatments, including steroid injections, have been questioned for their efficacy, prompting exploration into alternative therapies such as platelet-rich plasma (PRP) injections. This randomized, double-blinded, controlled trial aims to evaluate the effectiveness of high-concentration PRP (platelet-rich plasma) injection compared to saline (placebo) in reducing pain and disability in patients with thumb base osteoarthritis.
Patients meeting inclusion criteria will be randomized and blinded, with injections administered under sterile conditions and radiological guidance. With a planned sample size of 90 patients recruited from the Department of Hand Surgery at Södersjukhuset, Stockholm, the study will assess pain relief and functional improvement at 3, 6, and 12 months post-injection. The primary outcome measure is pain on load (numerical rating scale) at 6 months, with secondary outcomes including patient-reported outcomes, key pinch, grip strength, abduction of the thumb, and time to intervention within 1 year. Statistical analyses will employ non-parametric tests, chi-square tests, and generalized estimating equations to compare outcomes between the PRP and placebo groups.
The study aims to provide evidence regarding the efficacy of high-concentration PRP injections for thumb base osteoarthritis. If PRP proves superior to saline in reducing pain and improving function, it could offer a promising alternative treatment. Conversely, if PRP does not demonstrate significant benefits over placebo, its use for this condition is not justified. This study seeks to address the current gap in evidence regarding the efficacy of PRP injections for thumb base osteoarthritis.
The study has been approved by the Swedish Ethical Review Authority (2023-06860-01 and 2024-01238-02) and is registered on ClinicalTrials.gov (NCT06193499) 2024-01-04.
拇指基底部（大多角骨-小多角骨关节，CMC-1 关节）的骨关节炎较为普遍，尤其常见于中老年女性，可导致严重的残疾。包括皮质类固醇注射在内的保守治疗方法的疗效受到质疑，促使人们探索其他治疗方法，如富含血小板的血浆（PRP）注射。这项随机、双盲、对照试验旨在评估高浓度 PRP（富含血小板的血浆）注射与盐水（安慰剂）相比，在减轻拇指基底部骨关节炎患者疼痛和残疾方面的效果。
符合纳入标准的患者将被随机分组并进行盲法处理，在无菌条件下和影像学引导下进行注射。该研究计划在斯德哥尔摩的索德萨尔医院手外科招募 90 名患者，评估注射后 3、6 和 12 个月时的疼痛缓解和功能改善情况。主要终点是 6 个月时的负荷疼痛（数字评分量表），次要终点包括患者报告的结果、关键捏力、握力、拇指外展和 1 年内干预的时间。统计分析将采用非参数检验、卡方检验和广义估计方程来比较 PRP 组和安慰剂组的结果。
该研究旨在提供关于高浓度 PRP 注射治疗拇指基底部骨关节炎疗效的证据。如果 PRP 在减轻疼痛和改善功能方面优于盐水，那么它可能是一种有前途的替代治疗方法。相反，如果 PRP 没有显示出比安慰剂更显著的益处，那么它在这种情况下的使用就没有依据。本研究旨在解决目前关于 PRP 注射治疗拇指基底部骨关节炎疗效的证据差距。
该研究已获得瑞典伦理审查局的批准（2023-06860-01 和 2024-01238-02），并在 ClinicalTrials.gov 上注册（NCT06193499）。
