The Association Between STarT Back Tool Subgroups and Postural Stability
Primary Purpose
Low Back Pain, Postural
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Static balance testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Low Back Pain, Postural
Eligibility Criteria
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
Sites / Locations
- Sofiendal fysioterapi og kiropraktik
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
STarT Back Tool group 3
STarT Back Tool groups 1+2
Arm Description
Patients scored as high risk patients by the STarT Back Tool
Patients scored as low risk or medium risk patients by the STarT Back Tool
Outcomes
Primary Outcome Measures
Medial-Lateral body sway
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).
Secondary Outcome Measures
Medial-Lateral body sway
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).
Medial-Lateral body sway
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).
Anterior-Posterior body sway
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).
Anterior-Posterior body sway
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).
Body sway area
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).
Full Information
NCT ID
NCT03065439
First Posted
February 17, 2017
Last Updated
February 1, 2019
Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT03065439
Brief Title
The Association Between STarT Back Tool Subgroups and Postural Stability
Official Title
The Association Between STarT Back Tool Subgroups of Patients With Low Back Pain and Postural Stability Under Conditions of Sensory Deprivation and Cognitive Load
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Postural
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a double blinded experimental study comparing sub-groups of patients with low back pain
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STarT Back Tool group 3
Arm Type
Experimental
Arm Description
Patients scored as high risk patients by the STarT Back Tool
Arm Title
STarT Back Tool groups 1+2
Arm Type
Experimental
Arm Description
Patients scored as low risk or medium risk patients by the STarT Back Tool
Intervention Type
Diagnostic Test
Intervention Name(s)
Static balance testing
Intervention Description
Postural sway will be measured using a force plate (Metitur Good Balance System®).
Primary Outcome Measure Information:
Title
Medial-Lateral body sway
Description
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).
Time Frame
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.
Secondary Outcome Measure Information:
Title
Medial-Lateral body sway
Description
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).
Time Frame
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.
Title
Medial-Lateral body sway
Description
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).
Time Frame
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.
Title
Anterior-Posterior body sway
Description
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).
Time Frame
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.
Title
Anterior-Posterior body sway
Description
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).
Time Frame
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.
Title
Body sway area
Description
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).
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Riis, PhD
Organizational Affiliation
Research unit for General Practice in Aalborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sofiendal fysioterapi og kiropraktik
City
Aalborg
ZIP/Postal Code
9200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data analysed will be available from the corresponding author on reasonable request.
Citations:
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Citation
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The Association Between STarT Back Tool Subgroups and Postural Stability
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