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临床试验/DRKS00013762
DRKS00013762已完成不适用

ltrasound-based investigation of unilateral osteopenia in patients with CRPS of lower extremities compared to peripheral nerve lesions and postoperative or traumatic immobilization. - SAHARA

Abteilung für Endokrinologie und DiabetologieMedizinische Klinik Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHUK RUB0 个研究点目标入组 258 人开始时间: 2018年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
258

研究概览

简要总结

ocal osteopenia and altered bone metabolism are major complications of complex regional pain syndrome (CRPS), but quantitative assessment is difficult unless using X-ray or dual-energy X-ray absorptiometry. Ultrasound-based measurement of bone density (UBD) is a possible alternative but has never been used to detect unilateral disease such as CRPS. Therefore, the main outcome measure of this prospective study was the diagnostic utility of UBD in patients with lower-limb CRPS. Second, we compared the extent of unilateral and contralateral calcaneal bone density to that of other conditions with unilateral pain, general osteoporosis, and healthy subjects. Calcaneal osteodensitometry was bilaterally examined using ultrasound-based methodology. Bone mineral density values were converted to Z-scores based on age- and sex-dependent reference values. All patients completed a functional and an osteoporosis risk questionnaire. In patients with CRPS (n = 18), the bone mineral density values and Z-scores were significantly lower in both the affected (mean ± SD: 0.40 ± 0.08 and -1.1 ± 0.8, respectively) and nonaffected (0.46 ± 0.09 and -0.6 ± 0.9, respectively) limbs than in patients (n = 40) with other unilateral pain syndromes (affected: 0.51 ± 0.1 and -0.2 ± 1.1, respectively; nonaffected: 0.54 ± 0.11 and 0 ± 0.9, respectively) and healthy subjects (right side: 0.6 ± 0.1 and 0.1 ± 0.9, respectively). Conversely, in patients with known systemic osteoporosis, the Z-scores were lower bilaterally with smaller side-to-side differences than in those with CRPS (P < 0.05). Compared with subjects suffering from long-term CRPS (=2.4 years), patients with shorter disease duration exhibited significantly lower Z-scores (P < 0.05). In conclusion, UBD revealed that CRPS is associated with both local and systemic alterations of bone metabolism.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 85 Years(—)
性别
All

入选标准

  • 1. Patients suffering from CRPS, which were exposed to prolonged immobilisation or partial weight-bearing due to surgery or due to pain in hip or knee joints or appendicular bones.
  • 2. Control collectives:
  • a. Healthy individuals
  • b. Patients suffering from osteopenia or osteoporosis

排除标准

  • Missing informed consent – contraindications for SAHARA measurements (including local infection, skin lesions, hyperalgesia due to mechanical contact, metal implants in situ) – fractures with direct calcaneal affection – bilateral disease – insufficient knowledge of the German language or other problems affecting communication – severe cognitive or psychiatric disorders.

研究者

发起方
Abteilung für Endokrinologie und DiabetologieMedizinische Klinik Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHUK RUB

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