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临床试验/NCT03065439
NCT03065439已完成不适用

The Association Between STarT Back Tool Subgroups of Patients With Low Back Pain and Postural Stability Under Conditions of Sensory Deprivation and Cognitive Load

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Medial-Lateral body sway

研究概览

简要总结

Purpose This trial study the association between SBT subgroups and postural stability. It is theorized that cognitive impairment is more pronounced among patients in SBT group three compared to SBT group one and two. Therefore, it is hypothesized that challenging patients' balance will have a greater impact on the postural sway among patients in SBT group three compared to SBT group one and two in conditions where sensory information is reduced and cognitive load is increased.

详细描述

Globally low back pain (LBP) and neck pain are the leading causes of disability (1). Consequently, improvements in the assessment and treatment of LBP can have an extensive impact. Patients with LBP constitute a heterogeneous group and to improve treatment there is much focus on identifying subgroups of patients and tailor treatment accordingly. An example of this is the STarT Back Tool (SBT) which has been translated to more than 20 languages and is probably the most used tool for subgrouping of patients with LBP. The SBT sub-groups patients into three groups with a progressing need for treatment. Patients in group one should be given information on LBP and advice to stay active, patients in group two are also recommended supplementary treatment in primary care, and in addition patients in group three need attention to psycho-social issues (2-3). Accordingly to the SBT, patient in group three should be treated with cognitive therapy by a physiotherapist undergoing special training. This training includes mentorship and professional support to enable physiotherapists to elicit and address complex issues in patients with psycho-social barriers to recovery. Subgrouping by SBT and thereby treating patients in group three with cognitive therapy has been found effective in improving their functional outcomes (4-5).

Patients with LBP have found to have different postural control strategies than patients without LBP especially during tasks involving increased task complexity (6-7). However, some studies have not found decreased postural control among patients whit LBP (8-9). Heterogeneous study populations may explain the discrepancy in findings especially if subgroups of patients with LBP have affected postural control while other subgroups are not affected.

Patients with pain often present with some degree of cognitive impairments which could limit the extent to which daily activities could be performed. This may be particularly present among SBT group three patients. Cognitive impairments have been associated with decreased function and consequently reduced balance in elderly, indicating that postural stability requires significant amount of cognitive resource. Since the cognitive resources are limited, if additional tasks compete for these resources, performance in one or more tasks can become affected. The conscious interpretation of (or attention towards) painful stimulations is a costly process that uses significant amount of the cognitive resources available which could impair physical performance. Consequently, this may lead to additional postural sway and thereby restricted balance.

After given written informed consent patients fill in a questionnaire including age, gender, educational level (bachelor, yes/no), employment, sick leave, co-morbidity (other than LBP, yes/no), pain duration (2-6 weeks/sub-acute or chronic), pain intensity (NPR), Roland Morris Disability Questionnaire (23 question, RMDQ), self-reported health status (EQ-5D visual analogue scale). After filling in the questionnaire patients will be asked to take of their jacket and shoes and to empty their pockets, before measuring height, weight, and testing for static balance.

Postural sway will be measured using a force plate (Metitur Good Balance System®). The force plate will be placed with a distance of 100 cm to a wall in front of the patient and with more than 100 cm of free space to the sides and behind the force plate. The force plate, an equilateral triangle (800 mm), had four strain gauge transducer signals converted by a three-channel DC amplifier and transformed to digital data (50 Hz) and subsequently filtered digitally, using a three-point median filter and IRR filter, with 20 Hz cut-off frequency. On the wall in front of the patient a 12 cm circular green plate will be place in the patients' eye level. Patients will be asked to stand with their feet as closed positioned as possible, without lifting their feet, and to focus on the green plate in front of them. Patients will be asked to replicate this position for each test. The static balance test will require that the subjects stand as quiet as possible during 35 seconds in 4 different conditions in the following order: (i) eyes open and easy counting, (ii) eyes closed and easy counting, (iii) eyes closed and counting in multiples of seven, and (iv) eyes closed and counting backward from 500 in multiples of seven.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Balance testing will be performed and data saved without the testers knowing the results. Afterwards the testers will ask patients to fill in questionnaires. An assessor (not participating in testing) will be cleaning the data and establishing the models without knowledge of the SBT score. The STarT Back score will be cleaned, saved in another data set and established by another assessor. When agreed upon the model, the two data sets will be merged.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Low back pain for more than 14 days

排除标准

  • •Signs of serious pathology (e.g. signs of fracture, cauda equina syndrome, malignancy, osteoporosis, or spinal inflammatory arthritis)
  • •Blindness
  • •Dyslexia and not able to reply questionnaires unassisted
  • •Pregnancy
  • •Not able to walk unassisted

研究组 & 干预措施

STarT Back Tool group 3

Experimental

Patients scored as high risk patients by the STarT Back Tool

干预措施: Static balance testing (Diagnostic Test)

STarT Back Tool groups 1+2

Experimental

Patients scored as low risk or medium risk patients by the STarT Back Tool

干预措施: Static balance testing (Diagnostic Test)

结局指标

主要结局

Medial-Lateral body sway

时间窗: This is a cross sectional study all data will be collected during a 30 minute-session. The two balance tests for the primary outcome will be performed with a 1 minute interval.

Additional medial-lateral body sway accessed by analysis of the Center of Pressure (CoP) position. Measured as the difference in medial-lateral CoP range (cm) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven) and an easy 30 sec. test (open eyes and easy counting forwards).

次要结局

  • Anterior-Posterior body sway(This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.)
  • Body sway area(This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.)
  • Medial-Lateral body sway(This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.)
  • Medial-Lateral body sway(This is a cross sectional study all data will be collected during a 30 minute-session. The three balance tests will be performed consecutively within 2 minutes interval.)

研究者

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

Allan Riis

Post doc

Aalborg University Hospital

研究点 (1)

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