Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Ulster University

Recruitment countries:

United Kingdom

Health condition studied:

Pregnancy related low back pain
Signs and Symptoms
Pregnancy related low back pain

URL:

Link to the clinical trial website

About the trial

Interventions:

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.

Key inclusion and exclusion criteria:

• 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
• 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)

• Age minimum:
• Age maximum:
• Gender: Female

Primary outcomes:

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 outcomes:

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)

Target sample size:

1000

Study type:

Observational

Study design:

Single-centre prospective observational cohort study (Screening)

Contacts:

• Name: Julie McCullough
• Address: School of Health Sciences Ulster University Shore Road
• Phone: +44 2890 366811
• Email: j.mccullough@ulster.ac.uk
• Affiliation:

• Name: Sarah Dianne Liddle
• Address: School of Health Sciences Ulster University Shore Road
• Phone: +44 2890 366423
• Email: sd.liddle@ulster.ac.uk
• Affiliation:

Technical details

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

Sources of monetary support:

Chartered Society of Physiotherapy Charitable Trust (CSPCT)

Secondary sponsors:

Main ID:

ISRCTN17454132

Secondary ID:

16/NI/0072

Register:

ISRCTN

Date of registration:

24/11/2024

Date of first enrollment:

21/11/2024

Last refreshed:

19 December 2024