Pregnancy-related low back pain Signs and Symptoms
Conditions
Interventions
Current interventions as of 12/01/2023:
Materials and methods:
Study design and setting:
A single-centre, prospective observational cohort study will be employed, recruiting eligible, consenting pregn
Inclusion criteria:
1. Pregnant women booked to attend the study recruitment site for their routine 20 to 22-week anomaly scan
2. Fluency in English (verbal and written), access to the internet and ba
Sponsors
Ulster University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/01/2023: 1. Pregnant women attending the study recruitment site for their 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 years Previous 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 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/01/2023: 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) or other reasons identified by the treating midwife, e.g. social services involved with the mother/family Previous 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 12/01/2023: As this study will be the first of its kind to be carried out in a UK healthcare setting, a key outcome will be to determine the feasibility of recruiting pregnant women to the study over a 7-month recruitment period and to establish rates of, and reasons for, attrition over the four proposed study time points, i.e. 20-22 weeks gestation until 6 months after birth. Previous primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/01/2023: To describe women’s lived experience of this condition in more detail than we are currently able to do (using the six patient-reported outcome measures listed below. To describe women's use of, and satisfaction with, healthcare associated with pregnancy-related LBP (including NHS and out-of-pocket expenses). The following outcomes will be included in the online study questionnaire: 1. Pain intensity and bothersomeness measured using an 11-point numerical rating scale (NRS) 2. LBP-related functional disability assessed using the Roland Morris Disability Questionnaire 3. Days off work/early maternity leave 4. LBP-related fear-avoidance of physical activity using the Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale 5. Health-related quality of life using the EuroQol-5d-5l 6. Global perceived effect of treatment using the Global Perceived Change Scale All outcomes will be collected at T0 (20-22 weeks gestation), T1 (31-34 weeks gestation), T2 (6 weeks postpartum) and T3 (6 months postpartum) Previous secondary outcome measures: 1. Pain intensity and bothersomeness are 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 measured using an online questionnaire All outcomes are assessed at T0 (20-22 weeks gestation), T1 (31-34 weeks gestation), T2 (6 weeks postpartum) and T3 (6 months postpartum) | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactSarah Dianne;Julie Liddle;McCullough
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Outcome results
None listed