Osteoarthritis trials live on participant-reported pain and function, plus the rescue medication people take between visits. Capture puts the visit forms, the phone diary and the safety data in one study with one audit trail. Build and test the protocol in the free sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Target knee
Index knee
KNEEAverage pain, past 48 hours
PAINAVGPhysical function subscale
FUNCDerived from item scores, read-only
31 CalculatedRescue tablets taken since last visit
RESCUEAbove allowed limit of 10: confirm
What an osteoarthritis trial needs from its EDC
The study data
Most osteoarthritis drug and device trials ask the same question: does pain in the index joint fall more than on placebo, and does function improve? The answer is usually built from a participant-completed questionnaire. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is the long-standing example, with separate pain, stiffness and physical function subscales, and the Knee injury and Osteoarthritis Outcome Score (KOOS) is a related family that adds sport and quality-of-life domains. Registered knee trials also use a plain 0 to 10 or 100 mm pain rating as the primary, with WOMAC items as secondary, so the choice depends on the protocol. Imaging endpoints such as joint space width appear in structure-modification designs, and are typically read centrally rather than entered at the site.
The data-quality problem in these studies is mostly about consistency. Pain is rated over a recall window, often the past 48 hours, so a questionnaire completed on the wrong day is not comparable. Rescue analgesics change the number. A bilateral participant may be scored on the wrong knee at the next visit. In Capture each questionnaire is a form with typed fields per item, subscale and total scores calculated and shown read-only, and every entry attributed to a named user, with the old value, new value and reason for any change in the audit trail. Add an index-joint field to every form and a visit window around each scheduled week.
Placebo response is large in osteoarthritis pain, and the design counters it with run-in periods, consistent rater instructions and careful capture of concomitant treatment. That is a data-management task as much as a statistical one. A concomitant medication form with start and stop dates, indication and dose, built as a repeating table, lets analysts see which participants started a new analgesic or an injection. See the concomitant medications template for the layout, and the general pain context in EDC for chronic pain clinical trials.
A pain score can be collected three ways in one study. At the visit, the participant completes the questionnaire on a site device or on their phone. Between visits, a short diary asks for average and worst pain, with reminders and a completion window. And at the clinic, a performance test such as a timed walk is recorded by staff; the 6-minute walk test template shows how to lay out distance and symptoms. The numeric pain rating scale template and the VAS pain scale template cover the single-item ratings. Whichever scale you use, WOMAC, KOOS and similar instruments are normally licensed, so the licence stays with your study documents; Capture does not supply instrument wording or verify licences.
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 and index joint | Diagnosis, imaging grade, pain threshold at screening and baseline | Eligibility screening template with edit checks; index-joint field on every form |
| Primary pain score | Item scores, subscale total, recall window | Participant questionnaire or site form with calculated totals |
| Function and quality of life | Subscale totals at baseline and follow-up | Visit form per week; EQ-5D template for a generic health measure |
| Daily pain between visits | Average and worst pain, 0 to 10 | Phone diary with reminders; see pain diary |
| Rescue analgesic use | Tablets or doses since last visit | Visit form field with a range edit check; concomitant medications for detail |
| Performance test | Walk distance or timed task | 6-minute walk test form |
| Vitals and weight | Blood pressure, weight, BMI | Vital signs template; BMI calculated |
| Adverse events | Onset, severity, seriousness, relationship | Adverse event form |
Instrument wording is yours to supply. Licensed instruments stay with your study documents; Capture does not supply or verify instrument licences, and licence controls exist only on participant questionnaires.
Upload the protocol, let the AI draft visits and forms for you to review, and test with sample participants. Free sandbox, no credit card.
Safety and design variants
Oral analgesic and anti-inflammatory programmes share a safety profile that regulators watch in a population that is often older and on several medications. Blood pressure, weight, renal function and gastrointestinal symptoms are recorded at set visits, and a laboratory form with reference ranges and range edit checks makes a drifting value visible. The lab results template and lab data and reference range management show the pattern. Edit checks are data-management prompts that surface a value, not clinical alerting; the investigator safety procedures stay in the protocol.
Intra-articular injection studies add procedure data: the date, the joint, the product lot and any injection-site reaction. Device and surgical-adjacent studies, such as braces or knee procedures, add device identifiers and use records. Those fit a structured procedure form, and the wider pattern is in EDC for medical device clinical trials. Sports-related and post-injury osteoarthritis work overlaps with EDC for sports medicine clinical trials.
Multi-site recruitment is normal for a Phase 2 or Phase 3 pain programme. QR-code enrolment, site-level participant numbering and a site coordinator portal keep sites organised, PII segregation means coordinators see participant names while researchers see coded IDs, and exports can be filtered by site. For registrational programmes see Phase 3 EDC. Consent for a standard interventional design starts from the basic clinical trial consent template, with wording approved by your ethics committee.
Build sequence
A practical order of work for a sponsor or investigator 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.
Match each questionnaire to its recall period and set a visit window so a late completion is visible.
Build the rescue-use field and an edit check at the allowed limit, so overuse raises a query.
Create the pain diary with reminders and a completion window. Participants open a secure link on their own phone.
Run practice participants through the full schedule, trigger every check and show the principal investigator the working build.
Forms move from draft to approved, and approved forms lock for live use. Real participants start the paid live phase.
Before first participant
WOMAC, KOOS or other questionnaires licensed through their rights holders, with terms filed in the study documents.
How the target knee or hip is chosen and recorded for bilateral disease.
Allowed product, dose and count, and the edit check that enforces it.
Prior analgesics and injections captured with dates in the concomitant medication form.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. A questionnaire is built as a form with one typed field per item and calculated subscale and total scores. The licence for any published instrument stays with your study documents; Capture does not supply instrument wording or verify licences.
Through a phone diary that opens from a secure link in the browser, with reminders and a completion window you control. There is no app to install.
Yes. Add a count field on the visit form with a range edit check, and use the concomitant medications form for dates and doses. Breaking the rule raises an automatic query.
As a field on every form you choose. Capture does not decide the target joint for you, so write the rule in your protocol and data management plan.
Yes. CSV and Excel exports include a data dictionary, with raw and decoded files and by-site filtering. CDISC SDTM datasets can be exported as SAS XPT with Define-XML.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study via the demo page or the pricing page.
Keep exploring
EDC for chronic pain clinical trials
The wider pain view.
Numeric pain rating scale eCRF
The 0 to 10 layout.
Pain diary template
Phone diary between visits.
KOOS and Harris Hip Score eCRF
Knee and hip outcome forms.
EDC for sports medicine clinical trials
Injury and recovery studies.
ePRO software
Participant questionnaires and diaries.
Free sandbox with every feature. No credit card, and you pay only when you go live.