Low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
Following completion of consent and baseline questionnaires, the internet intervention software, LifeGuide, will randomise the participant. The randomisation sequence will be automatically generated,
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 and above 2. Current low back pain (have experienced pain in the last week) with or without sciatica 3. Access to the internet and an active email address 4. Ability to read/understand English without assistance 5. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. ‘Red flag’ signs and symptoms in a patient with LBP which indicate serious spinal pathology such as infection, malignancy, fracture, inflammatory back pain, progressive neurology and/or cauda equine; or suspected serious pathology 2. Have had spinal surgery in the past six months 3. Pregnancy 4. Taken part in the prior SupportBack feasibility study (ISRCTN31034004)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Back-specific physical disability, assessed using the Roland Morris Disability Questionnaire (RMDQ) at the baseline and after 6 weeks and 3, 6 and 12 months (a repeated measures design) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health economics, assessed in terms of: 1.1. Health-related quality of life, assessed using the EQ-5D-5L at the baseline and after 6 weeks and 3, 6 and 12 months 1.2. Self-reported over the counter (OTC) medication use, assessed using a single item developed for this study at the baseline and after 6 and 12 months 1.3. Participant borne costs, assessed by participant-reported resource use and time off work at the baseline and after 6 and 12 months 1.4. Brief occupational items, assessed using an occupational questionnaire at the baseline and after 6 and 12 months 1.5. Health care resource use (including GP appointments, nurse appointments, referrals, hospital stays and medication between specified dates, along with data on pre-existing conditions), assessed using a GP medical records review at the 12 month follow up 2. Pain, assessed in terms of: 2.1. Number of troublesome days in pain over the last month, assessed using a single-item Days In Pain Questionnaire at the baseline and after 6 weeks and 3, 6 and 12 months 2.2. Numerical Pain Rating Scale, assessed at the baseline and after 6 weeks and 3, 6 and 12 months 2.3. Risk of persistent disability, assessed using the Keele STarT Back screening tool at the baseline and after 12 months 3. Psychological processes related to pain, assessed in terms of: 3.1. Fear of movement, assessed using the Tampa Scale for Kinesiophobia (TSK-11) at the baseline and after 12 months 3.2. Negative orientation towards pain, assessed using the Pain Catastrophizing Scale (PCS) at the baseline and after 12 months 3.3. Confidence in ability to manage pain, assessed using the Pain Self-Efficacy Questionnaire at the baseline and after 6 weeks and 12 months 3.4. Self-efficacy for managing low back pain, assessed using a single item from Keele's Musculoskeletal Health Questionnaire tool (MSK-HQ) at the baseline and after 6 weeks and 3, 6 and 12 months 3.5. How much the intervention may reduce limitation due to back pain, assessed using the | — |
Countries
England, United Kingdom
Contacts
Public ContactFrances Webley
Outcome results
None listed