Low back pain trials run on patient-reported scores that move slowly, a rescue-medicine diary that is easy to forget, and treatment sessions that vary by clinic. Capture holds the questionnaires, function tests, rescue use and adverse events in one study with one audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
ODI score, percent
34 / 100
What a low back pain trial needs from its EDC
The study data
Low back pain studies are some of the most varied in musculoskeletal research. Chronic pain drug trials, injection and device studies, exercise and physiotherapy programmes, spinal manipulation, cognitive and behavioural approaches, and surgical comparisons all report on a similar family of outcomes. Recent registered trials commonly use change in the Oswestry Disability Index as the primary outcome, with a 0 to 10 numeric pain rating and PROMIS pain interference and physical function measures as secondary outcomes. The Roland-Morris Disability Questionnaire is also widely used. The NIH Task Force on research standards for chronic low back pain proposed a minimum dataset that classifies people by pain intensity, interference and physical function, and asked for responder analyses alongside mean scores.
Because these outcomes are patient-reported, the main data capture task is to get the right questionnaire to the right person on time and to keep scoring clean. The Oswestry Disability Index template shows how a 0 to 100 percentage score and item responses sit in one form, and the numeric pain rating scale template and VAS pain scale template cover single-item pain ratings. A brief pain inventory template covers pain severity and interference together. The ODI is copyrighted and licensed through its rights holder; Capture does not supply the wording, and the licence stays with your study documents. Participant questionnaires can carry licence number, holder and expiry in the app, and nothing is blocked while those are missing.
What counts as an improvement is a design choice. Published estimates of minimal important change vary with how the anchor question is defined; one trial reported ranges of roughly 15 to 40 percent reduction. Do not hard-code a threshold into the form. Store the raw item responses, the total and the date, and let the statistical plan define responders. The glossary entry on the minimal clinically important difference explains the concept.
A participant who takes an extra analgesic on a bad day has a lower pain score and a higher exposure. Build a short rescue diary: date, product, dose and a reason, opened from a phone link with a weekly reminder, plus a visit-level summary question so a missing diary is visible. Concomitant medication changes belong on the concomitant medications form. For opioid-sparing or medication-reduction designs, the diary is closer to an outcome than a covariate, so decide this before the build.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Pain duration, neurological findings, red-flag exclusions, imaging, prior treatment | Eligibility form with skip logic; medical history form |
| Disability and function | Disability index, item responses, total, date | Oswestry template structure as a phone questionnaire |
| Pain intensity | 0 to 10 rating now, average and worst, over a defined period | Numeric pain rating template structure in built-in ePRO |
| Physical performance | Timed tests, range of motion, assessor ID, blinded flag | Site eCRF form for the blinded assessor |
| Treatment delivery | Session date, type, duration, clinician, adherence to home exercise | Repeating session form |
| Rescue and concomitant medication | Product, dose, date, reason | Phone diary plus concomitant medications form |
| Safety | AE term, grade, seriousness, relationship, action | Adverse event form |
Capture records the data your protocol defines. Responder thresholds and score handling are set by the statistical plan.
Upload the protocol, let the AI draft the visits and forms for review, then answer the questionnaire as a practice participant on your own phone. Free sandbox.
Blinding and bias
Many back pain trials cannot blind the participant, since exercise or manual therapy is obvious, so the next best protection is a blinded assessor and clean scoring. In Capture, blinded roles never receive treatment-arm values; this is enforced by masked database views and row-level security, not only by hiding a column in the interface. Put assessor-measured function on a separate site form, and record the assessor ID. See blinded and unblinded role management and randomization for how arms stay hidden.
Missing questionnaires are the main threat to a patient-reported outcome. Reminders and visit windows help, and the compliance view shows by site who is overdue. Participants often answer more completely on a phone than at a clinic desk, and the link opens in the browser with no app install; see byod ePRO. When a score is entered after the window, the audit trail shows when and by whom.
Safety depends on the intervention. Exercise and manual therapy trials mostly record musculoskeletal flare-ups, which still need onset, grade and relationship. Drug trials add the product’s own profile, and injection or device studies add procedure-related events. Neurological deterioration is an event a protocol will usually want reported quickly. Keep severity, seriousness and causality as separate answers, and use the SAE report form for serious events.
Build sequence
A realistic order of work for a clinic, university or sponsor team.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Disability and pain forms as phone questionnaires with visit windows, plus reminders.
A blinded assessor form with assessor ID, and a repeating treatment session form.
A short weekly diary and a visit-level summary question with an edit check for gaps.
Run practice participants through a missed questionnaire, a rescue-heavy week and a flare-up event, approve the forms and start the paid live phase when real participants enrol.
Sites and exports
Physiotherapy and spine studies usually run across several clinics. Capture supports QR-code enrolment, site-level participant numbering, a site coordinator portal and by-site filtering and exports; see multi-site clinical trial management. Orthopaedic and registry-style follow-up is covered in EDC for orthopaedic outcomes registries, and the wider pain picture in EDC for chronic pain clinical trials.
Exports come as CSV or Excel with an automatic data dictionary, and CDISC SDTM export gives SAS XPT datasets with Define-XML (SDTM export). For a continuous disability outcome, start with the two means sample size calculator, and add a margin for non-response with the dropout-adjusted calculator.
Before first participant
Instrument, version, recall period, timing and handling of missing items in the statistical plan.
Questionnaire terms confirmed with their rights holders and kept in the study documents.
The threshold and anchor used, defined in analysis and not hard-coded in a form.
Who assesses function, who delivers treatment and who sees the arm.
Permitted products, how use is recorded and what counts as a deviation.
Wide CSV with data dictionary opened in the statistics package.
You can build it as a phone questionnaire with a visit window and reminders, with the total stored beside the item responses. Capture does not supply the licensed wording; your team confirms terms with the rights holder and files them with the study documents.
Yes. A short phone diary records date, product, dose and reason, and a visit-level summary question makes missing entries visible.
Blinded roles never receive treatment-arm values; this is enforced in the database, not just the interface. Assessor-measured function sits on its own site form with an assessor ID.
No. It stores item responses, totals and dates. Responder thresholds and score handling are set in your statistical plan and applied in analysis.
Yes. A repeating session form records date, type, duration and clinician, so dose of treatment exports as data. Multi-clinic delivery uses site-level numbering and by-site exports.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
Oswestry Disability Index template
Score and item structure for a disability index.
Numeric pain rating scale template
A 0 to 10 pain rating form.
EDC for chronic pain clinical trials
Pain endpoints and rescue medication across indications.
EDC for orthopaedic outcomes registries
Long follow-up of musculoskeletal outcomes.
Capture ePRO
Questionnaires, reminders and completion windows.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.