Built straight from the pilot protocol. The design, endpoints, device status and the six protocol pages are already written in as attachments — you fill in the sponsor, the investigator and the local details a board asks for.
The protocol's six pages, listed in the order a board reads them.
Page 1 — Background and rationale
Pulsed radiofrequency energy in postoperative pain and edema: what the published evidence shows, where it is inconclusive, and why this indication was chosen first.
Page 2 — Design, randomisation and blinding
40 participants, 1:1 randomised, double-blind, sham-controlled. Allocation is held server-side; the sham applicator is identical to the active one and produces no output.
Page 3 — Population and eligibility
Adults following elective foot or ankle surgery. Inclusion and exclusion criteria, including exclusion of any active implanted electronic device.
Page 4 — Intervention and dosimetry
Applicator, placement, session length, sessions per day and course length. Output values come from Amendment A bench dosimetry, not from published figures.
Page 5 — Endpoints and assessment schedule
Primary and secondary endpoints with the follow-up timetable at 1 hour, 24 hours and days 3, 7, 14 and 30.
Page 6 — Safety, statistics and milestones
Per-session safety screening, individual and study-level stopping rules, adverse-event reporting, the analysis plan and the project timeline.
Amendment A goes with it as the bench dosimetry record — a board should not see dose values that came from published papers rather than your own measurement.
APPLICATION FOR ETHICAL REVIEW OF RESEARCH INVOLVING HUMAN PARTICIPANTS
Submitted 2026-09-18
Study title: Pulsed radiofrequency energy for postoperative pain and edema after elective foot and ankle surgery: a randomised, double-blind, sham-controlled pilot
Protocol version: 1.0
Review board: [IRB or ethics committee name]
1. SPONSOR
Sponsor: [sponsor legal name]
Responsible officer: [name, title, contact]
Funding: [funding source]
2. PRINCIPAL INVESTIGATOR
Name: [principal investigator]
Credentials: [degrees, licence, specialty]
Institution: [institution]
Contact: [phone and email]
Human-subjects training: [course, certificate, date]
Co-investigators and staff: [names and roles]
Study site(s): [study site]
3. STUDY DESIGN AND PURPOSE
Design: Randomised 1:1, double-blind, sham-controlled pilot study
Participants: 40
Follow-up: 30 days of follow-up per participant
Purpose: To estimate the effect size of pulsed radiofrequency energy on postoperative edema and pain, so that a pivotal trial can be sized. This pilot is not powered to prove efficacy.
4. ENDPOINTS
Primary: Ankle edema at day 7, measured by the figure-of-eight tape method on both ankles, reported as the difference from the unoperated side.
Secondary:
- Pain on the 0–10 numeric rating scale at each follow-up point.
- Analgesic consumption, recorded as daily morphine milligram equivalents.
- WOMAC pain subscale score at day 30.
- Wound surface area from photo planimetry, where a wound is present.
- Adverse events and device-related events across the 30 days.
Assessment points: 1 hour, 24 hours, Day 3, Day 7, Day 14, Day 30.
Measurement rule: Tape measurement repeats to roughly ±3 mm at a limb landmark, so a change smaller than 3 mm is treated as measurement noise, not a result.
5. DEVICE STATUS
The device is investigational for this indication. Participants are told so in
plain language, and half of them receive an identical sham applicator that
produces no output. Allocation is held outside the study team. Anyone with an
active implanted electronic device is excluded, and the applicator itself locks
out rather than warning.
6. RECRUITMENT AND CONSENT
Recruitment: [recruitment method]
Consent process: [consent process]
7. RISK, BENEFIT AND DATA
Risks: [risks and how they are minimised]
Anticipated benefit: [anticipated benefit]
Data handling: [de-identification and storage plan]
Safety monitoring: [monitoring and reporting plan]
8. ATTACHMENTS
Attachment 1 — Protocol page 1: Background and rationale
Pulsed radiofrequency energy in postoperative pain and edema: what the published evidence shows, where it is inconclusive, and why this indication was chosen first.
Attachment 2 — Protocol page 2: Design, randomisation and blinding
40 participants, 1:1 randomised, double-blind, sham-controlled. Allocation is held server-side; the sham applicator is identical to the active one and produces no output.
Attachment 3 — Protocol page 3: Population and eligibility
Adults following elective foot or ankle surgery. Inclusion and exclusion criteria, including exclusion of any active implanted electronic device.
Attachment 4 — Protocol page 4: Intervention and dosimetry
Applicator, placement, session length, sessions per day and course length. Output values come from Amendment A bench dosimetry, not from published figures.
Attachment 5 — Protocol page 5: Endpoints and assessment schedule
Primary and secondary endpoints with the follow-up timetable at 1 hour, 24 hours and days 3, 7, 14 and 30.
Attachment 6 — Protocol page 6: Safety, statistics and milestones
Per-session safety screening, individual and study-level stopping rules, adverse-event reporting, the analysis plan and the project timeline.
Attachment A — Amendment A, bench dosimetry record for the study device.
Attachment B — Informed consent form.
Attachment C — Investigator curriculum vitae and training certificates.
9. READINESS CHECKLIST
[ ] Amendment A bench dosimetry completed and signed
[ ] Sponsor named, with a responsible officer
[ ] Principal investigator identified and qualified
[ ] Informed consent form drafted
[ ] Safety screening and hardware lockout verified on the study units
[ ] Randomisation and blinding held outside the study team
[ ] Data handling and de-identification plan