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临床试验/NCT03490071
NCT03490071已完成不适用

Three and Seven Year Follow-up of Patients Reported Symptoms, Function and Quality of Life in Patients With Longstanding Hip and Groin Pain Referred to Tertiary Care. A Longitudinal Study

Lund University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS)

研究概览

简要总结

In this longitudinal cohort study including young to middle aged people with longstanding hip and groin pain (LHGP) referred to tertiary care, we will collect data of patient reported symptoms, function and quality of life three and seven years after the initial contact with orthopedic surgeon.

详细描述

81 physically active patients (18-55 years) with (LHGP) who were enrolled in a cross-sectional study (Diagnosis and functional limitations in the young to middle-aged physically active population with long-standing hip/groin pain: A cross-sectional study) during the period October 2014 to January 2017 will be recruited to this longitudinal cohort study.

A research coordinator will contact the patients and provide them with written and oral information about the study. Patients who accept to participate will electronically complete the following questionnaires. The same questionnaires were included at baseline, i.e., in the cross-sectional study.

  • Copenhagen Hip and Groin Outcome Score (HAGOS)
  • HSAS - Hip Sports Activity Scale (HSAS)
  • Patient Specific Functional Scale
  • Medical Outcomes Study short form 36 (SF-36)
  • K-10 questionnaire
  • Self-Presentation in Exercise Questionnaire (SPEQ)
  • Multidimensional Scale of Perceived Social Support (MSPSS)

Additional questions about treatment, medication, patient satisfaction and perceived change in hip function will be included.

For descriptive purposes, the mean difference (95% CI), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. Separate linear regression models will be used to evaluate the change in each variable compared to baseline values.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • At baseline, the following inclusion and

排除标准

  • Inclusion criteria:
  • Unilateral or bilateral hip/groin pain >3 months
  • Age 18-55 years
  • No previous hip surgery
  • Exclusion criteria:
  • Hip pathology (i.e., Perthes' disease)
  • Verified moderate or severe osteoarthritis (OA) (Tönnis grade >1)
  • Palpable hernia
  • Low-back pain with a positive Lasègue test
  • MRI-verified lower back/spine pathology (i.e., spinal stenosis, disc herniation)
  • Other musculoskeletal co-morbidities overriding the hip-related symptoms and dysfunction
  • Co-morbidities excluding physical activity and training
  • Psycho-social disorders
  • Drug abuse
  • Not understanding the language of interest.

结局指标

主要结局

Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS)

时间窗: 3 and 7 years after baseline (cross-sectional study)

Patient reported outcome regarding hip dysfunction, which includes six subscales; pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activity, and quality of life. The score for each subscale ranges from 0-100, where 0 indicates extreme problems and 100 no problems. Patient Acceptable Symptom State (PASS) will be derived from HAGOS score using previously described cut-off values for the different subscales

次要结局

  • Additional questions regarding treatment, medication, patient satisfaction and perceived change in hip function.(3 and 7 years after baseline (cross-sectional study))
  • Self-Presentation in Exercise Questionnaire (SPEQ)(3 years after baseline (cross-sectional study))
  • K-10 questionnaire(3 years after baseline (cross-sectional study))
  • HSAS - Hip Sports Activity Scale (HSAS)(3 and 7 years after baseline (cross-sectional study))
  • The Multidimensional Scale of Perceived Social Support (MSPSS)(3 years after baseline (cross-sectional study))
  • Medical Outcomes Study short form 36 (SF-36)(3 and 7 years after baseline (cross-sectional study))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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