Chiropractic trials run in private clinics, with treatment recorded session by session, blinded assessors who must stay blinded and adverse reactions that are easy to under-report. Capture gives each clinic its own site, a per-session treatment log and a phone diary. Build free, no credit card.
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| Treating chiropractor | Outcome assessor | Participant | Statistician | |
|---|---|---|---|---|
| Allocation (active or sham) | ||||
| Treatment log (technique, region) | ||||
| Pain and disability outcomes | ||||
| Adverse reaction reports | ||||
| Blinding check at final visit |
What chiropractic research needs from its data collection
The research setting
Most chiropractic research is not run by a hospital research office. It happens in private clinics, at chiropractic colleges and in practice-based research networks where practitioners recruit their own patients and treat them in routine clinic time. The data challenges follow from that: staff who are clinicians first and data managers never, no dedicated coordinator, patients who see the practitioner several times a week during the first weeks, and treatments that are hands-on and hard to describe in a word. A tool built for a pharmaceutical trial with a research pharmacy and monitors on site is the wrong fit, and so is a spreadsheet passed between clinics.
In Capture every clinic can be its own site, with QR-code enrolment, site-level participant numbering and a site coordinator portal. A solo practitioner who is also the investigator can run a small study alone; a network of ten clinics can compare sites through by-site filtering and exports. PII segregation means whoever does recruitment sees names while the research team works from coded IDs. That structure also fits the practical reality that the person entering data is often the person treating. For multi-clinic operation see multi-site clinical trial management.
The condition-specific pages cover the clinical content. Neck and back pain trials, which are the most common chiropractic indications, are described in EDC for low back pain trials; the Oswestry layout is on the Oswestry Disability Index template. This page is about running the study in a chiropractic setting, and is deliberately separate from the physiotherapy trial page, which covers exercise-based interventions and supervised dose logs.
A manipulation is not a tablet. For each session record the date, the clinician, the technique (for example high-velocity low-amplitude, mobilisation, soft-tissue work or a sham procedure), the spinal region, the number of segments treated, session length and any advice or exercise given. Build it as a repeating row so a course of twelve sessions is twelve rows, each with its own audit trail. Add a deviation field for sessions that depart from the protocol. This is the data that lets a reviewer see what treatment each person actually received, whatever their allocation said.
Procedure delivered
PROCRegion treated
REGIONSegments treated
SEGNUMSession length
SESSMINReaction reported since last session
REACTAdverse event form opened
Where this fits
| Question | This page | Condition or discipline page |
|---|---|---|
| Whose study is it? | Chiropractors, colleges and chiropractic research networks | Low back pain is the condition across all disciplines |
| What is delivered? | Manual therapy sessions with technique and region | Physiotherapy trials cover exercise dose and supervised programmes |
| What sets the blinding plan? | Practitioner cannot be blinded; protect assessor and participant | Blinding guide for the general rules |
| Who is the site? | A clinic, often with one or two clinicians | Multi-site management for the cross-clinic view |
| What is the main safety question? | Post-session reactions and rare serious events | Adverse event reporting workflow |
Build the treatment log, give a clinician a login and enter a mock course of care. Free sandbox, no credit card.
Safety and blinding
Systematic reviews of randomised trials of spinal manipulation have repeatedly described adverse-event reporting as inconsistent and incomplete, and many trials do not say how events were collected. Sham-controlled trials that did record them tended to report mostly mild, short-lived effects such as local tenderness and tiredness (a placebo-controlled migraine trial of chiropractic manipulation is one example). Take that as a reason to design collection, not as a safety conclusion. Define the events you will ask about, the time window after each session, who classifies seriousness and how a participant reports between visits. Children need extra care in design and consent, and trials involving them should be reviewed by an ethics committee with paediatric expertise.
In Capture an adverse event form with seriousness, severity, relationship and sign-off covers both mild reactions and serious events; see the adverse event template. A short post-session question on the phone diary asks every participant the same thing 24 hours later. This does not replace the investigator's clinical judgement or emergency advice, and the protocol should state what a participant does if symptoms worsen.
Blinding is mostly about roles. Manipulation versus sham cannot be hidden from the treating practitioner, so the outcome assessor, the participant and the statistician carry the blind. Capture's blinded roles never receive treatment-arm values, enforced by masked database views and row-level security, not only by the screen. Randomisation can sit in the same study; see randomization in EDC. A blinding question at the final visit (what do you think you received) is a standard check, and it belongs on the assessor form.
Build sequence
Create each clinic as a site, add practitioners, the outcome assessor and the data entry person, and decide who sees names.
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.
Add the repeating session form with technique, region, segments, length and reaction question.
Create the pain and function diary and the 24-hour reaction question, with reminders.
Log in as the assessor in the sandbox and confirm allocation is not visible anywhere.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
A shared list of procedures and regions so clinics record the same thing the same way.
What a sham involves, and how it is documented without revealing allocation to the assessor.
Which reactions are asked about, the window after each session, and the seriousness rules.
Rights-holder terms for any questionnaire filed in the study documents.
A short walkthrough of enrolment, the session form and the query screen for each practitioner.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. Capture supports multiple sites with site-level participant numbering, QR-code enrolment, a site coordinator portal and by-site filtering and exports.
Yes, as a repeating row per session with technique, region, segments, length and a reaction question. Each row has its own audit trail.
Through blinded roles that never receive treatment-arm values, enforced by masked database views and row-level security. Randomisation can sit in the same study.
No. The investigator records relationship, severity and seriousness on the adverse event form. Capture records, routes for sign-off and exports the data.
No. The low back pain page covers the condition and its outcomes. This page is about the setting: clinics as sites, a treatment log for manual therapy, sham blinding and adverse reaction collection.
Yes. A single-site study can have one person as investigator and data entry. Start in the free sandbox and pay only once real participants are enrolled.
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.
Keep exploring
EDC for low back pain trials
The condition and its outcomes.
Physiotherapy trial software
Exercise dose and rehab outcomes.
Oswestry Disability Index template
Function layout for back pain.
Multi-site trial management
Several clinics, one view.
Adverse event template
Severity, relationship and sign-off.
Pricing
Free sandbox, pay at go-live.
Free sandbox with every feature. No credit card, and you pay only when you go live.