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临床试验/CTRI/2024/07/071675
CTRI/2024/07/071675已完成不适用

Effect of Whole Body Vibration versus Proprioceptive Neuromuscular Facilitation on Chemotherapy- Induced Peripheral Neuropathy: A Randomized Clinical Trial

Srushti Jegarkal1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

研究概览

简要总结

This randomized clinical trial was conducted to assess and compare the therapeutic impacts of WBV and PNF on neuropathic pain, sensory function, balance, and quality of life in individuals suffering from CIPN. A total of 32 participants, each having undergone a minimum of three cycles of chemotherapy, were randomly divided into two groups: one receiving WBV and the other PNF, with both groups also participating in standard physiotherapy exercises. Over a span of three weeks, participants engaged in nine intervention sessions, and outcomes were measured using validated assessment tools such as the S-LANSS, SWMT, MiniBESTest, and the FACT-GOG-Ntx. The results indicated significant improvements across all measured outcomes in both groups, highlighting the effectiveness of both treatment modalities. WBV was particularly effective in enhancing sensory function, while PNF yielded better results in terms of balance and the functional and social aspects of quality of life. Both interventions resulted in a statistically significant decrease in neuropathic pain, although no notable differences were found between the two groups in this area. The study advocates for the use of WBV and PNF as safe, accessible, and effective non-pharmacological rehabilitation methods for managing CIPN, suggesting that personalized physiotherapy strategies could be developed based on individual functional impairments.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Willing to participate.
  • Age 18-70 years all genders.
  • Diagnosed case of CIPN.
  • Minimum 3 doses of chemotherapy or have completed chemotherapy treatment.

排除标准

  • Severe neuropathic symptoms requiring immediate medical care.
  • Pre-existing peripheral neuropathy not related to chemotherapy treatment.
  • Individuals with a history of severe cardiovascular disease or orthopedic conditions.
  • Cognitive impairment or psychiatric disorders.
  • Unstable medical conditions.

结局指标

主要结局

Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

时间窗: Baseline and after 3 weeks

Semmes Weinstein Monofilament

时间窗: Baseline and after 3 weeks

MiniBESTest

时间窗: Baseline and after 3 weeks

Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT-GOG Ntx)(v4)

时间窗: Baseline and after 3 weeks

次要结局

未报告次要终点

研究者

发起方
Srushti Jegarkal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Srushti Jegarkal

KAHER Institute of Physiotherapy

研究点 (1)

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