Condition category
Signs and Symptoms
Date applied
09/11/2016
Date assigned
24/11/2016
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many women are thought to experience low back pain (LBP) during their pregnancy, with symptoms typically increasing as pregnancy advances, and often continuing after birth. For many women, pain can become so severe that it leads to daily functional limitations, including time off work and disrupted sleep. There are some studies indicating that women often feel frustrated that their symptoms are not taken seriously, but we know little about the true extent of this problem in Northern Ireland, what treatments are available to women, and how helpful women think they are. Therefore, this study is taking place in to find out the best ways to collect information from a group of pregnant women about whether, or not, they develop LBP by following them from their 20 to 22-week scan until six months after their baby is born. This will be done by exploring the LBP history, initial symptoms and how they progress, types of treatment received and outcomes by asking women to complete a secure online questionnaire at four different time points, two during pregnancy and two after the birth. The findings will be used to design a much larger study of this kind in the future aimed at improving the management of pregnancy-related LBP.

Who can participate?
Pregnant women attending the Ulster Maternity Unit for their anomaly scan. They do not have to have LBP to take part.

What does the study involve?
Midwives direct potential participants to a member of the research team on the day of their 20 to 22-week scan. The meeting lasts for approximately one hour, and allows the researcher to check the participant is eligible to take part, and answer any questions they may have about the study. Eligible participants are asked at this point to complete a study consent form, and a number of secure online questionnaires. These questionnaires are then repeated when participants are between 31-34 weeks pregnant and then six weeks and six months after they have had their baby.

What are the possible benefits and risks of participating?
There will be no direct benefit to participants. However, they will have an important input to the future design of services to manage pregnancy-related LBP. Participation will involve a time commitment to complete the questionnaires at each of the follow-ups. Also, there is a risk of participants becoming upset, for example, when answering questions about previous pregnancies. Every step has been taken to minimise these risks.

Where is the study run from?
Ulster Hospital Maternity Outpatients Department (UK)

When is study starting and how long is it expected to run for?
June 2016 to May 2018

Who is funding the study?
Chartered Society of Physiotherapy Charitable Trust (UK)

Who is the main contact?
1. Dr Sarah Dianne Liddle (public)
sd.liddle@ulster.ac.uk
2. Dr Julie McCullough (public)
j.mccullough@ulster.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Sarah Dianne Liddle

ORCID ID

Contact details

School of Health Sciences
Ulster University
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 2890 366423
sd.liddle@ulster.ac.uk

Type

Public

Additional contact

Dr Julie McCullough

ORCID ID

Contact details

School of Health Sciences
Ulster University
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 2890 366811
j.mccullough@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16/NI/0072

Study information

Scientific title

Watching Pregnancy Project: A study looking at low back pain (LBP) symptoms, previous LBP episodes, treatmentsavailable and outcomes in a sample of pregnant women

Acronym

WPP

Study hypothesis

The aim of this study is to explore low back pain (LBP) history, presentation, progression, type(s) of treatment and subsequent patient reported outcomes in a sample of pregnant women from initial presentation until six months after birth.

Ethics approval

Office of Research Ethics Committees Northern Ireland (ORECNI), 12/08/2016, ref: 16/NI/0072

Study design

Single-centre prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Pregnancy related low back pain

Intervention

An online data collection tool (designed using Qualtrics software) will automatically generate a unique identifier for each participant and, once consent has been provided (at the beginning of the questionnaire), participants will be directed to sections on general demographic information, parity and risk factors for LBP such as; history of (low back Pain) LBP, hypermobility and / or amenorrhea, and information about current LBP. For the purposes of this study, LBP will be defined using the standard criteria of ‘pain or discomfort in the area between the lowest rib and the gluteal folds (+/- referral into lower limb) lasting 7 days or more since the beginning of pregnancy’. Women reporting LBP at baseline (T0) will be asked whether they have already received, or been referred for treatment and/or out-of-pocket expenses incurred for treatment, along with data relating to:
1. Pain intensity and bothersomeness
2. LBP-related functional disability (using the Roland Morris Disability Questionnaire)
3. Days off work / early maternity leave
4. LBP-related fear
5. Health-related quality of life
6. Global perceived effect of treatment

The questionnaires will be completed at the anomaly scan between 20 to 22 weeks’ gestation; between 31 to 34 weeks’ gestation; 6 week’s post-partum; and 6 month’s post-partum.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility of recruitment and retention of pregnant women is recorded using the online questionnaire within the timeframe of the study namely beginning at 20 to 22 weeks’ gestation, again at 31 to 34 weeks’ gestation, at 6 week’s post-partum, and finally 6 month’s post-partum.

Secondary outcome measures

1. Pain intensity and bothersomeness is measured using an 11-point numerical rating scale (NRS)
2. LBP-related functional disability is assessed using the Roland Morris Disability Questionnaire
3. Days off work/early maternity leave is assessed using an online questionnaire
4. LBP-related fear is measured using the Fear-Avoidance Beliefs Questionnaire
5. Health-related quality of life is measured using the EuroQol-5d-5l
6. Global perceived effect of treatment is measured using the Global Perceived Change Scale
7. Use of and satisfaction with, health care (including NHS and out-of-pocket expenses) associated with pregnancy related LBP are measurd using an online questionnaire

All outcomes are assessed at at T0 (20-22 weeks gestation), T1 (31-34 weeks gestation), T2 (6 weeks postpartum) and T3 (6 months postpartum)

Overall trial start date

01/06/2016

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. All pregnant women attending the South Eastern Health and Social Care Trust for 20 to 22-week anomaly scan
2. Willing to take part in the study at all time points
3. Fluency in English (verbal and written)
4. Access to, and basic IT literacy (to complete follow-up questionnaires)
5. Aged 18-65

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1000 pregnant women

Participant exclusion criteria

1. Red flags indicating serious spinal pathology, e.g. cancer, cauda equina lesion
2. Diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia, scoliosis
3. History of systematic / inflammatory disease
4. Spinal surgery within the last 12 months
5. Diagnosed with urinary tract infection (that may manifest as LBP)

Recruitment start date

21/11/2016

Recruitment end date

01/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ulster Hospital
Maternity Outpatients Department Upper Newtownards Road
Dundonald
BT16 1RH
United Kingdom

Sponsor information

Organisation

Ulster University

Sponsor details

Shore Road
Newtownabbey
BT37 0QB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Chartered Society of Physiotherapy Charitable Trust (CSPCT)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Dissemination of the study findings are planned for publication in a high-impact peer reviewed journal, internal reports, at national and international conferences and publication on Chartered Society of Physiotherapy and Ulster University Institute of Nursing and Health Research websites.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (Ulster University’s research data repository).

Intention to publish date

30/09/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes