このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

The Association Between STarT Back Tool Subgroups and Postural Stability

2019年2月1日 更新者:Allan Riis、Aalborg University Hospital

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

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.

調査の概要

状態

完了

詳細な説明

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.

The force platform, scale, and person altimeter will be calibrated every fortnight or more frequent. Data will be extracted, checked for any abnormal discrepancies, and saved on a secure driver frequently (at least every fortnight).

研究の種類

介入

入学 (実際)

65

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Aalborg、デンマーク、9200
        • Sofiendal fysioterapi og kiropraktik

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Low back pain for more than 14 days

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:診断
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:STarT Back Tool group 3
Patients scored as high risk patients by the STarT Back Tool
Postural sway will be measured using a force plate (Metitur Good Balance System®).
実験的:STarT Back Tool groups 1+2
Patients scored as low risk or medium risk patients by the STarT Back Tool
Postural sway will be measured using a force plate (Metitur Good Balance System®).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Medial-Lateral body sway
時間枠: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).
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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Medial-Lateral body sway
時間枠: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.
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 medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
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.
Medial-Lateral body sway
時間枠: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.
Additional medial-lateral body sway will be accessed by analysis of the difference in CoP; velocity (cm/s) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
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.
Anterior-Posterior body sway
時間枠: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.
Additional anterior-posterior body sway will be accessed by analysis of the difference in CoP; range (cm) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
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.
Anterior-Posterior body sway
時間枠: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.
Additional anterior-posterior body sway will be accessed by analysis of the difference in CoP; velocity (cm/s) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
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
時間枠: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.
Additional sway area accessed by area of an ellipse fitted to the 95% confidence interval of the Center of Pressure position (cm2). Measured as the difference in area (cm2) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Allan Riis, PhD、Research unit for General Practice in Aalborg, Denmark

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年2月4日

一次修了 (実際)

2019年2月1日

研究の完了 (実際)

2019年2月1日

試験登録日

最初に提出

2017年2月17日

QC基準を満たした最初の提出物

2017年2月22日

最初の投稿 (実際)

2017年2月28日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月4日

QC基準を満たした最後の更新が送信されました

2019年2月1日

最終確認日

2019年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • AllanRiis_6

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

The data analysed will be available from the corresponding author on reasonable request.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する