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临床试验/NCT05076994
NCT05076994Unknown不适用

The PET Project: Patient Education Tool for Home Exercise

Lawson Health Research Institute0 个研究点目标入组 50 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Pain

研究概览

简要总结

Patients presenting to an musculoskeletal (MSK) outpatient clinic who fit the study inclusion criteria (low back pain, outer hip pain) will be randomized to receive an exercise prescription with patient education alone, or in clinic patient education and access to the Patient Education Tool (Series of videos). Weekly surveys will be done via email to assess patient adherence: the main outcome. Two follow-up in-clinic visits at weeks 6 and 12 will assess pain, function and exercise self-efficacy: the secondary outcomes. Comparisons will be made between the group of the patients who received the videos and those who did not.

详细描述

Musculoskeletal conditions are a very common, if not the most common, reason to visit the family doctor, comprising an estimated one-in-six to over half6 of all primary care visits. Under this umbrella of musculoskeletal conditions fall many different aliments: this paper will investigate chronic nonspecific low back pain and greater trochanter pain syndrome.

Boasting titles for greatest number of disability-years caused by a disease and most common non-communicable disease, one would hope that researchers and clinicians would thoroughly understand what causes this pervasive morbidity. Unfortunately, when it comes to chronic nonspecific low back pain (CNLBP), no clear pathoanatomic cause is attributed to the symptoms.

Low back pain is localized below the costal margin and above the inferior gluteal folds and is deemed chronic when it lasts for more than 12-weeks. Although most cases of low back pain seem to resolve prior to the 12-week mark, chronic low back pain is responsible for the vast majority of workers' compensation costs. In 90% of cases of chronic low back pain, clinicians cannot pinpoint the etiology, hence the 'non-specific' modifier.

Greater trochanter pain syndrome (GTPS) boasts a slightly less impressive resume - affecting a mere 10% to 25% of the general population. GTPS presents as lateral hip pain, specifically over the greater trochanter, and is worse when lying or bearing weight on that side.

It too has a plethora of potential aetiologies, and although it can be challenging to elucidate lateral hip pain's true etiology this clinical diagnosis comprises of trochanteric bursitis, gluteus medius and minimus tendinopathies, and external coxa saltans (commonly referred to as "snapping hip").

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • Over 18 years old
  • The ability to perform at least 5 of the 10 total exercises, as cleared by the physiatrist
  • The willingness to comply with the study criteria for its 12-week duration
  • The written informed consent of the participant
  • Sufficient English comprehension to understand the questionnaires
  • Sufficient English comprehension to consent to the study
  • Chronic lower back pain:
  • o A history of lower back pain exceeding 3 months
  • Greater trochanter pain syndrome:
  • A history of lateral hip pain exceeding 3 months
  • Pain in at least three of the following tests: palpation of the greater trochanter, FABER test, resisted external de-rotation test, modified resisted external de-rotation test

排除标准

  • Pregnancy
  • Condition that makes the exercising ill advisable, as determined by the physiatrist
  • Chronic lower back pain:
  • Known lumbar disc herniation
  • Acute phase of lumbar disc protrusion
  • Known vertebral fractures
  • Known infectious, inflammatory, or malignant diseases of the vertebrae
  • Known presence of severe spinal deformity
  • Greater trochanter pain syndrome:
  • Acute hip pathology such as fracture, dislocation, infection, etc.
  • Known diagnosis moderate to severe hip osteoarthritis causing significant range of motion restriction

结局指标

主要结局

Pain

时间窗: 12 weeks

Change in Visual Analogue Scale (VAS) ("No Pain" on one end of scale (0 out of 100), and "Worse pain you can imagine" on the opposite end of the scale (100 out of 100)

次要结局

  • Self efficacy and confidence of participants(12 weeks)
  • Exercise Adherence Rate(Number of exercises performed each 1 day (24 hours). Data collected once weekly for 12 weeks via online automated survey.)

研究者

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

Steven Macaluso

Associate Professor

Lawson Health Research Institute

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