Fibromyalgia trials are won or lost on patient-reported data: a daily pain score, a global impression of change and impact questionnaires. Capture puts those diaries on the participant's phone and the visit forms at the site, in one study. Build and test free, no credit card.
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Daily pain diary (demo)
Participant 004-0023 · Day 21
Average pain over the past 24 hours
PAIN24Sleep quality last night
SLEEPWhat a fibromyalgia trial needs from its EDC
The study data
Fibromyalgia is diagnosed clinically, often against the ACR criteria for widespread pain and symptom severity, and there is no laboratory marker, so trial outcomes are patient-reported. In recent Phase 3 programmes the primary endpoint is typically the change from baseline in the mean daily average pain score on an 11-point numeric rating scale, assessed at around week 8 to 14 depending on the design. Responder definitions are common: a reduction of at least 30% in mean pain, sometimes also 50%, and the Patient Global Impression of Change rated much or very much improved. Some trials define a composite response requiring both. Secondary endpoints usually include the FIQR total and subscores, sleep disturbance, fatigue and sometimes cognition and depression or anxiety measures.
The daily diary changes the data-management problem. A weekly mean built from seven daily entries is a statistic that depends on how many days exist. Protocols usually set a minimum number of valid days for a week to count, and a baseline period before randomisation that has to be stable enough to enter treatment. In Capture the diary is a scheduled daily task opened from a secure link in the phone browser, with reminders by email or SMS and a completion window you set. The compliance view by site shows who is falling behind in time to act, and a baseline-week completeness rule can be built as an edit check on the randomisation visit. The pain diary template and numeric pain rating scale template show the structure; wording and recall period come from your protocol. See also digital patient diary for clinical studies.
The other trap is the placebo response, which is large in fibromyalgia trials and is influenced by expectation, visit frequency and site behaviour. An EDC cannot reduce it, but it can make the contributors visible: pain at screening versus baseline, variability across the baseline week, site-level response patterns on the dashboard. Where a protocol uses a placebo run-in, build it as an epoch so the transition is explicit in the data. For the chronic pain family as a whole, see EDC for chronic pain clinical trials.
Most fibromyalgia endpoints are participant-reported (pain, PGIC, FIQR), while the clinician contributes eligibility, tender point or widespread pain assessment where the protocol requires it, physical examination and safety. The VAS pain scale and brief pain inventory templates show related pain layouts, and the FACIT-Fatigue and Insomnia Severity Index pages cover common secondary measures. Licensed instruments stay in your study documents; Capture does not supply or verify licences, and licence controls exist on participant questionnaires only, which is where most of these sit.
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Diagnosis and eligibility | Criteria met, pain threshold, washout of prohibited drugs | Eligibility screening template |
| Daily average pain | 0 to 10 entry each day, weekly mean | Phone diary with reminders; pain diary |
| Baseline stability | Minimum valid days and score range in the baseline week | Edit check at the randomisation visit |
| Global impression of change | Patient rating at visits | Participant questionnaire at scheduled visits |
| FIQR | 21 items, function, impact and symptoms | ePRO task at visits; licensing per rights holder |
| Sleep and fatigue | Secondary scales | Insomnia Severity Index, FACIT-Fatigue |
| Concomitant medications | Analgesics, antidepressants, anticonvulsants, rescue | Concomitant medications template |
| Safety | Dizziness, somnolence, weight gain, events of interest | Adverse event form |
Licensed instruments stay with your study documents. Capture does not supply or verify instrument licences; 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 data. Free sandbox, no credit card.
Design details
Fibromyalgia designs commonly start with a screening period, a baseline diary week or two, then randomisation to a parallel-group treatment period, and sometimes a taper or follow-up. Some use enriched enrolment or randomised withdrawal after an open-label phase, where only responders continue. Each is an epoch with its own visit plan. Rescue analgesia needs a rule: whether it is permitted, how it is recorded and whether use counts as a treatment failure. Build a rescue use field into the diary or a short visit form and define the handling in the data management plan before the first participant.
Because sleep and activity are core to the condition, some studies add wearable data. Capture supports a native OAuth sync with Oura, where the study team enables the device per study, can mark it required, and participants connect their own account; no other device integration is claimed. See EDC for wearable device studies. Treat wearable sleep and activity as exploratory unless your statistical plan says otherwise, and keep the pain diary as the controlled primary record.
Multi-site recruitment and long follow-up are normal; QR-code enrolment, site-level numbering and a separate site coordinator portal help with the first, reminders and compliance views with the second. See multi-site clinical trial management and Phase 3 EDC.
Build sequence
A practical order of work.
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.
A daily task with reminders and a completion window; participants answer through a secure link.
An edit check at randomisation on the number of valid diary days and score range.
FIQR and global impression at the visits your protocol sets.
Run practice participants through baseline, randomisation and follow-up, skipping diary days to test the rule.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
Pain, FIQR, PGIC and secondary scales under their rights holders' terms, filed in the study documents.
Minimum diary days for a weekly mean and for baseline.
Diary and visit questionnaires use the recall periods in the protocol.
How rescue analgesia is recorded and analysed.
Timing and escalation for missed days.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. A 0 to 10 numeric rating question can be scheduled daily and opened from a secure link in the phone browser, with reminders by email or SMS and a completion window. No app is needed.
Capture stores the daily entries and baseline values and exports them with a data dictionary, so your statistician can derive the weekly mean and responder flags. You can also build calculated fields where the rule is simple.
Yes, as a participant questionnaire at scheduled visits. The licence for any published instrument stays with your study documents; Capture does not supply wording or verify licences.
With an edit check on the randomisation visit that tests the number of valid diary days and score range you define. The check raises an automatic query.
Yes. Arms and epochs let each phase have its own visit plan under the same participant record.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal and by-site exports.
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.
Free sandbox with every feature. No credit card, and you pay only when you go live.