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Trial registered on ANZCTR

Registration number

ACTRN12618000446268

Ethics application status

Approved

Date submitted

28/02/2018

Date registered

28/03/2018

Date last updated

26/07/2019

Date data sharing statement initially provided

26/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Is pelvic floor dysfunction associated with development of transient low back pain during prolonged standing?

Scientific title

Is there an aberrant trunk muscle coactivation in women with stress urinary incontinence that is associated with development of transient low back pain during prolonged standing?

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stress urinary incontinence

Low Back Pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Neurological

Other neurological disorders

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a self-controlled case series design (SCCS), a method used for investigating the association between a transient exposure (prolonged standing) and an adverse event (development of back pain). SCCS is considered to be a superior design to cohort or case-control studies when there is uncertainty over control of fixed confounders (Petersen, Douglas, & Whitaker, 2016), in this case UI. Participants will be positioned on a 0.50 x 0.46 m force platform and instructed to stand in their usual manner for prolonged standing (120 min). They must stay within the confines of the force platform borders and may not rest limbs on the tray in front of them. Participants will be given a set of tasks similar to those performed in prolonged standing occupations, such as, ‘computer work’, ‘card dealing’, ‘checkout scanning’ and ‘small object assembly’ (Nelson-Wong et al., 2008). This protocol has been established as a valid tool for predicting risk for chronic LBP in apparently healthy populations (Nelson-Wong & Callaghan, 2010; Nelson-Wong & Callaghan, 2014). The intervention is simply the prolonged time spent standing and will be administered to all participants. It will be administered by one of the study investigators and overseen by a physiotherapist.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Lifestyle

Comparator / control treatment

The control group are approx 30 apparently healthy women over the age of 18 with no reported history of UI or Low Back Pain. They will undergo the same intervention of prolonged standing of 120min.

Control group

Active

Outcomes

Primary outcome [1]

First primary outcome is Low Back Pain. Measured at baseline and each 10min interval. Pain level will be measured on a 100 mm visual analogue scale (VAS) with end-points of ‘no-pain’ (far left) and ‘worst pain imaginable’ (far right) (Huskisson, 1974). Pain quality is assessed at the primary timepoint via McGill Pain Questionare (Melzack, 2005; Trudeau et al. 2012)

Timepoint [1]

Baseline and repeated every 10 minutes to 120 minutes (primary timepoint).

Primary outcome [2]

muscle coactivation coefficients between the PFM and IO/TrA. Muscle activation will be measured by surface electromyography (sEMG). Raw EMG will be sampled at 1000Hz from electrodes adhered bilaterally as per international guidelines (SENIAM; Hermens et al., 2000). The EMG signal will be processed as per Nelson-Wong, Gregory, Winter & Callaghan, 2008 to examine the signal overlap between muscle pairs. Cross-correlation analyses will be used to quantify coactivation between the muscle pairs, the coefficient of co-activation will be expressed as a % for each block (Nelson-Wong et al., 2010).

Timepoint [2]

Baseline and repeated every 10 minutes to 120 minutes (primary timepoint).

Primary outcome [3]

Postural sway, measured as the range of CoP trajectory. Centre of pressure (CoP) displacement in the anterior-posterior and mediolateral directions will be recorded from a force platform samplig at 1000Hz with amplifier gain of 4000 (AMTI, Watertown, MA). We will compare the CoP range for each block as well as dynamic structure of the CoP characterized by sample entropy (SampEn) (Rhea, Kiefer, Haran, Glass, & Warren, 2014).

Timepoint [3]

Baseline and every 10 min to 120min (primary timepoint)

Secondary outcome [1]

[This is a primary outcome] Muscle coactivation patterns gluteus medius bilaterally as coefficient of coactivation (%). Muscle activation will be measured by surface electromyography (sEMG). Raw EMG will be sampled at 1000Hz from electrodes adhered bilaterally as per international guidelines (SENIAM; Hermens et al., 2000). The EMG signal will be processed as per Nelson-Wong, Gregory, Winter & Callaghan, 2008 to examine the signal overlap between muscle pairs. Cross-correlation analyses will be used to quantify coactivation between the muscle pairs, the coefficient of co-activation will be expressed as a % for each block (Nelson-Wong et al., 2010).

Timepoint [1]

[This is a primary outcome measure so will be measured at baseline and every 10 min to 120min (primary timepoint)]

Secondary outcome [2]

Assessment of Pelvic Stability will be made via active straight leg raise test as per Mens et al., 1999;2001. Quality/ability of movement will be assessed as per Mens and colleagues using a six-point scale to rate the level of difficulty: "not difficult at all = 0; minimally difficult = 1; somewhat difficult = 2; fairly difficult = 3; very difficult = 4; unable to do = 5" (2001, p. 1169).

Timepoint [2]

Measured at baseline and at primary timepoint 1.

Secondary outcome [3]

Assessment of general physical ability and fitness using a 4-week activity scale measured via Minnesota Leisure Time Physical Activity Questionnaire (Folsom et al., 1986)

Timepoint [3]

Baseline

Secondary outcome [4]

Assessment of trunk stability will me made by measuring time to fatigue in side support as per Hicks et al., 2005 & McGill et al., 1999.

Timepoint [4]

Baseline

Secondary outcome [5]

Pelvic Asymmetry Ratio will be measured by the following equation as per Al-Eisa et al., 2006 (ASIS height difference/ASIS width) + (PSIS height difference/PSIS width).

Timepoint [5]

Baseline

Eligibility

Key inclusion criteria

Inclusion Criteria for UI group:
Participants will be included if they have current Stress Urinary Incontinence symptoms (QUID), experiencing leakage at least once per month (min score of 1 point (out of 32) for the Total M-ISI Severity Domain). Continence type will be evaluated with the Questionnaire for Urinary Incontinence Diagnosis (QUID), which is a valid and reliable tool to assess the potential for pelvic floor dysfunction (Bradley et al., 2010). Symptom severity will be assessed with the Michigan Incontinence Symptom Index (M-ISI).
Inclusion Criteria for Healthy Controls:
Healthy with no history of UI symptoms and Michigan Incontinence Symptom Index (M-ISI) score of 0.

Minimum age

18 Years

Maximum age

65 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion Criteria for Both groups:
Any lifetime event of LBP sufficient to cause > 3 days of missed work/school/sport or seeking attention/treatment from medical personnel either physiotherapy, osteopathy, medical doctor or chiropractor; hip pain or pathology including previous hip surgery; current pregnancy or within 6 months’ post-partum; those with severe allergies or upper respiratory infections.
Exclusion Criteria for UI Group:
UI that is deemed from the QUID outcome to be urge UI or mixed UI;

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size was calculated as needed to achieve beta = 0.85 with alpha = 0.05, utilising a relative risk incidence of rho = 3 and ratio of risk to observation period of r = 0.142 (sourced from previous studies Bussey et al., 2016; Nelson-Wong & Callaghan, 2010).
The statistical analysis will be undertaken with R (version 2.15.3, R core team, 2012). To determine whether co-activation patterns of the pelvic floor and trunk muscles can predict transient low back pain during the prolonged standing task a logistic regression model will be used. For this, Pain status (Pain and No Pain) will be entered in the model as the response variable and muscle coactivation coefficients, CoP, parity history and BMI as the predictors. To determine whether UI status predicts pain outcome a linear regression model with a predictor variable of UI status and the response variable ‘greatest change in VAS score’.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

23/07/2018

Actual

23/07/2018

Date of last participant enrolment

Anticipated

31/03/2020

Actual

Date of last data collection

Anticipated

31/03/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago Researach Committee

Address [1]

362 Leith St, North Dunedin, Dunedin, New Zealand, 9016

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Melanie Bussey

Address

55 Union Street West, Dunedin, New Zealand, 9054

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Daniela Aldabe

Address [1]

270 Great King Street, Department of Anatomy, University of Otago, Dunedin, New Zealand, 9016

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Daniel Ribeiro

Address [2]

325 Great King St, School of Physiotherapy, University of Otago, Dunedin, New Zealand, 9016

Country [2]

New Zealand

Secondary sponsor category [3]

Individual

Name [3]

Stephanie Madill

Address [3]

1121 College Dr, School of Physical Therapy, University of Saskatchewan, Saskatoon, Canada, SK S7N.

Country [3]

Canada

Other collaborator category [1]

Individual

Name [1]

Niels Hammer

Address [1]

270 Great King Street, Department of Anatomy, University of Otago, Dunedin, New Zealand, 9016

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Stephanie Woodley

Address [2]

270 Great King Street, Department of Anatomy, University of Otago, Dunedin, New Zealand, 9016

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

362 Leith St, North Dunedin, Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

18/01/2018

Approval date [1]

05/02/2018

Ethics approval number [1]

H18/009

Summary

Brief summary

Prolonged standing has been associated with an increased prevalence of back pain in both laboratory and epidemiologic studies (Andersen et al 2007) and is recognised as a potential workplace hazard for employees who may stand for up to 75% of their work time such as, retail staff, assembly line workers, and healthcare personnel, among others (“Standing Problem,” 2005; Parent-Thirion et al., 2012).  
Recent research indicates that prolonged standing might lead to transient LBP in workers without previous history of back injury (Gallagher et al 2014; Marshall et al 2011; Nelson-Wong et al, 2010). Those individuals who developed pain during standing work usually experience first symptoms within 15 to 45 min, in conjunction with significant muscle co-activation anomalies, such as high co-activation of the gluteus medius, compared to non-pain developers. Transient back pain by definition exists solely during the exposure time and dissipates quickly once the standing ceased. However, Nelson-Wong and Callaghan (2014) found that transient LBP developers were 3 times more likely to experience chronic LBP over the next 24 months, seek medical care within 3 years of their participation, and report multiple episodes of chronic LBP. Although LBP during the 2-hour standing protocol is transient in nature, it has been shown to be a positive predictor for future chronic and recurrent LBP (Callaghan et al., 2015; Nelson-Wong & Callaghan, 2014).  
LBP is more prevalent in women than men (Schneider, Randoll, & Buchner, 2006).  Further, many recent studies have highlighted an association between LBP and urinary incontinence (UI) (Arab, Behbahani, Lorestani, & Azari, 2010; Bush et al., 2013; Cassidy et al., 2017; Eliasson, Elfving, Nordgren, & Mattsson, 2008).  In fact, women with UI are more than twice as likely to experience frequent back pain as those without UI (Smith, Russell, & Hodges, 2009). Additionally, women with greater severity of UI also report an increased severity and greater disability related to their back pain (Kim et al., 2011).  The function of the pelvic floor muscles in supporting continence is well known (Dumoulin, 2010; Price, Dawood, & Jackson, 2010).  However, the pelvic floor muscles play important roles in spinal stability as they naturally coactivate with other trunk muscles such as the transvers abdominis (Hodges, Sapsford, & Pengel, 2007). Given the pelvic floor muscles’ dual roles, it is logical to hypothesize a relationship between pelvic floor function, continence status and the development of lower back pain.
The primary objective of this research is to improve work-related health outcomes for women by elucidating significant predictors of LBP during prolonged standing. The main purpose of the study is to determine whether co-activation patterns between the pelvic floor and trunk muscles during a 2-hour prolonged standing task can predict transient low back pain in healthy women with and without pelvic floor dysfunction.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Melanie Bussey

Address

55 Union St West, School of Physical Education Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand, 9054

Country

New Zealand

Phone

+6434798981

Fax

melanie.bussey@otago.ac.nz

Contact person for public queries

Name

Melanie Bussey

Address

55 Union St West, School of Physical Education Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand, 9054

Country

New Zealand

Phone

+6434798981

Fax

melanie.bussey@otago.ac.nz

Contact person for scientific queries

Name

Melanie Bussey

Address

55 Union St West, School of Physical Education Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand, 9054

Country

New Zealand

Phone

+6434798981

Fax

melanie.bussey@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We are undecided at this time.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3445	Study protocol	Bussey, M. D., Aldabe, D., Ribeiro, D. C., Madil, S., Woodley, S., & Hammer, N. (2019). Is pelvic floor dysfunction associated with development of transient low back pain during prolonged standing? A protocol. Clinical Medicine Insights: Women's Health, 12. doi: 10.1177/1179562X19849603

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