The Association Between STarT Back Tool Subgroups and Postural Stability

NCT03065439 | Completed

• 1 other identifier: AllanRiis_6
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Postural

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (5)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

STarT Back Tool group 3

EXPERIMENTAL

Patients scored as high risk patients by the STarT Back Tool

Diagnostic Test: Static balance testing

STarT Back Tool groups 1+2

EXPERIMENTAL

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

Diagnostic Test: Static balance testing

Interventions

Static balance testing DIAGNOSTIC_TEST

Postural sway will be measured using a force plate (Metitur Good Balance System®).

STarT Back Tool group 3; STarT Back Tool groups 1+2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain for more than 14 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Sofiendal fysioterapi og kiropraktik

Aalborg, 9200, Denmark

Location

Related Publications (9)

• Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

  PMID: 24665116 BACKGROUND

• Main CJ, Sowden G, Hill JC, Watson PJ, Hay EM. Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's 'high-risk' intervention (StarT Back; ISRCTN 37113406). Physiotherapy. 2012 Jun;98(2):110-6. doi: 10.1016/j.physio.2011.03.003. Epub 2011 Jun 12.

  PMID: 22507360 BACKGROUND

• Sowden G, Hill JC, Konstantinou K, Khanna M, Main CJ, Salmon P, Somerville S, Wathall S, Foster NE; IMPaCT Back study team. Targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281). Fam Pract. 2012 Feb;29(1):50-62. doi: 10.1093/fampra/cmr037. Epub 2011 Jun 27.

  PMID: 21708984 BACKGROUND

• Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.

  PMID: 21963002 BACKGROUND

• Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, Konstantinou K, Main C, Somerville S, Sowden G, Wathall S, Young J, Hay EM; IMPaCT Back Study team. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med. 2014 Mar-Apr;12(2):102-11. doi: 10.1370/afm.1625.

  PMID: 24615305 BACKGROUND

• Mientjes MI, Frank JS. Balance in chronic low back pain patients compared to healthy people under various conditions in upright standing. Clin Biomech (Bristol). 1999 Dec;14(10):710-6. doi: 10.1016/s0268-0033(99)00025-x.

  PMID: 10545625 BACKGROUND

• Mok NW, Brauer SG, Hodges PW. Hip strategy for balance control in quiet standing is reduced in people with low back pain. Spine (Phila Pa 1976). 2004 Mar 15;29(6):E107-12. doi: 10.1097/01.brs.0000115134.97854.c9.

  PMID: 15014284 BACKGROUND

• Salavati M, Mazaheri M, Negahban H, Ebrahimi I, Jafari AH, Kazemnejad A, Parnianpour M. Effect of dual-tasking on postural control in subjects with nonspecific low back pain. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1415-21. doi: 10.1097/BRS.0b013e3181a3a917.

  PMID: 19478663 BACKGROUND

• Maribo T, Schiottz-Christensen B, Jensen LD, Andersen NT, Stengaard-Pedersen K. Postural balance in low back pain patients: criterion-related validity of centre of pressure assessed on a portable force platform. Eur Spine J. 2012 Mar;21(3):425-31. doi: 10.1007/s00586-011-1981-5. Epub 2011 Aug 24.

  PMID: 21863458 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan Riis, PhD

  Research unit for General Practice in Aalborg, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doc

Model Details: This is a double blinded experimental study comparing sub-groups of patients with low back pain

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 28, 2017
• Study Start: February 4, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)