Acupuncture clinical trial data collection

The STRICTA checklist (2010 revision, developed with the CONSORT group) asks authors of acupuncture trials to describe the rationale, the details of needling, the treatment regimen, other components of treatment, practitioner background and the control or comparator. Its control item says that when a sham or other acupuncture-like control is used, it should be described in the same detail as the active treatment. Check the current checklist you plan to follow, but the design conclusion is stable: record the intervention at session level, not only as a protocol description.

Build the session form as a repeating row. Per session, capture date, practitioner, procedure delivered, points used (a code or free text per point set), unilateral or bilateral, needle number, needle size or type, depth, response sought (such as de qi), whether electrical or manual stimulation or moxibustion was added, retention time and any other treatment given (advice, exercises, herbs). A deviation field marks sessions that depart from the protocol. A course of twelve sessions is twelve rows, each with its own audit trail, so the number delivered and actual exposure can be analysed whatever the allocation said. For a flexible treatment set, record the points actually used each time. For the generic repeating-visit approach used in a manual-therapy setting, compare EDC for chiropractic research.

TCM trials often add a diagnosis step, syndrome or pattern differentiation, which determines the points or formula. Record the practitioner's pattern diagnosis, the date and the signs used (tongue, pulse, as the protocol defines them) as structured fields, with a lock after baseline if the protocol says the diagnosis is fixed. If a herbal formula is prescribed, use the product and batch approach described in EDC for herbal medicine trials.

Minor events such as bruising, pain at the needle site, drowsiness and fainting are common enough to ask about at every session, while serious events from needling are rare and should have a named reporting route. Put a reaction question on each session form and a 24-hour follow-up question on the participant's phone, and open an adverse event form with severity, relationship and sign-off when a reaction crosses the threshold in the protocol. See the adverse event template. Capture records and routes; the investigator makes the judgement, and the protocol states what a participant should do if symptoms worsen.

Most acupuncture trials measure pain, function, symptoms or quality of life, often with weekly diaries over a long follow-up. Build these as ePRO forms completed on the phone with reminders, with the assessor seeing only scores. Because acupuncture is usually delivered in a clinic, each treatment clinic can be a site with its own participant numbering and QR enrolment, and the site coordinator portal serves the person managing appointments. Multi-clinic studies, for example a comparison of two clinics, rely on multi-site clinical trial management.

Pragmatic trials compare acupuncture with usual care without a sham. In that case there is no blinding of participants, so assessor blinding, objective outcomes and a clear record of actual treatment received matter more; see pragmatic clinical trial software. Condition-specific outcome sets, for example for back pain, are on the low back pain trials page.