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临床试验/NCT07173413
NCT07173413招募中不适用

Evaluating the Quality of Telephone Follow-Up After Spine Surgery: A Non-Inferiority Study

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Oswestry Disability Index

研究概览

简要总结

The aim of this study is to investigate whether the quality of physiotherapy follow-up after spinal surgery can be maintained when conducted by telephone rather than in-person. The study is motivated by the desire to save healthcare resources and reduce the environmental impact of patient travel. Data from patient records, including age, sex, surgery procedure, use of pain medication, and time spent on either phone or in-person follow-ups, will be collected to evaluate whether telephone-based follow-up is an effective and sustainable alternative for post-operative care.

详细描述

This study aims to evaluate the effectiveness and patient experience of telephone-based versus in-person physiotherapy follow-up after spinal surgery. Patients are allocated to one of two groups based on the day of the week they undergo surgery. This allocation determines whether the patient receives a follow-up assessment by telephone or in-person with a physiotherapist.

Following their assigned follow-up, patients are asked to complete questionnaires via REDCap regarding their satisfaction with the follow-up, regardless of the modality. These questionnaires also collect information on pain, physical function, and health-related quality of life. In addition to the initial assessment immediately after the follow-up, patients are sent the same questionnaires again at one and three months post-surgery.

The primary objective of the study is to compare outcomes between the two groups, evaluating whether telephone-based follow-up provides a comparable level of satisfaction, pain management, functional recovery, and quality of life to traditional in-person follow-up. The results will inform whether telephone follow-up is a viable and resource-efficient alternative to in-person assessments while maintaining high standards of post-operative care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have undergone lumbar spine surgery at the Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark.
  • Able to read and understand Danish.

排除标准

  • Withdrawel of consent

结局指标

主要结局

Oswestry Disability Index

时间窗: Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.

The ODI is a validated questionnaire assessing disability related to low back pain. It includes 10 items covering pain and daily functional limitations. Each item is scored from 0 to 5, where 0 represents minimal limitation and 5 represents severe limitation. The total score ranges from 0 to 50, with higher scores indicating greater disability.

次要结局

  • Health related quality of life(Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.)
  • Patient Satisfaction with Follow-up (Modified CSQ-8)(Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.)
  • Back and leg pain (VAS, 0-100 mm)(Immediately after the postoperative follow-up consultation with the physiotherapist, 1 month, and 3 months post-surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Christiansen Gandløse

Principle investigator

Aalborg University Hospital

研究点 (1)

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