Clinic Checklist: Ultrasound Therapy Contraindications, FDA & Canada
Ultrasound therapy should not be applied over a pregnant uterus, the eyes, active malignancy in the treatment field, thromboembolic conditions, active infection, ischemic tissue, recent bleeding, open growth plates, or the thorax when a pacemaker is present. These are absolute contraindications. Beyond them, safe use depends on the specific device, its dose, and a site-by-site screening process before every session, not a single generic checklist.
TL;DR:
Ultrasound therapy over the pregnant uterus, eyes, or near the brain and spine should be avoided due to potential tissue heating or mechanical effects that can harm the fetus or neural tissue.
Caution is necessary when treating areas with implants, electronic devices, or near growth plates, and every session must include site-specific screening and device-specific parameter adjustments.
Thromboembolic conditions, active infections, recent bleeding, ischemic tissues, and thoracic treatment over a pacemaker are absolute contraindications because of risks like clot dislodgement, bacterial spread, or device malfunction.
Lower-intensity devices such as low-intensity pulsed ultrasound or diagnostic imaging have different contraindication profiles, requiring careful identification of device type, dose, and manufacturer instructions.
Proper screening before each session, monitoring patient responses, and adjusting parameters are essential to prevent burns, embolic events, or nerve injury during ultrasound therapy.
Table of Contents
Absolute contraindications and their typical medical rationale
Some situations call for a flat no, and the reasoning is grounded in how ultrasound energy behaves in tissue. Over a pregnant uterus, thermal and mechanical energy can affect a developing fetus, with the first trimester carrying particular vulnerability, a concern reflected in Health Canada’s safety guidance. The eye is avoided because the lens has poor blood flow to dissipate heat, so even modest energy can accumulate to unsafe levels. Treatment near the brain, spine, or large peripheral nerves carries similar concerns about localized heating of neural tissue.
Thromboembolic conditions and active deep vein thrombosis are generally contraindicated because mechanical agitation near a clot risks dislodging it, and FDA premarket guidance for ultrasonic diathermy devices specifically lists these alongside malignancy in the treatment field and areas of recent bleeding.
A few other categories round out the list:
Active infection in the treatment area, since heating can accelerate bacterial spread.
Ischemic tissue, where added metabolic demand from heating can worsen tissue compromise.
Growth plates that have not yet closed, addressed in more detail later in this piece.
Thorax over an implanted pacemaker, a site-specific rule spelled out in device labeling recommendations.
FDA guidance directs manufacturers to list contraindications by anatomic site rather than by diagnosis alone, which is why device labeling for ultrasonic diathermy names areas like the thorax with a pacemaker, reproductive organs, and the brain or spine explicitly. That site-first framing is worth adopting in practice: ask where you’re treating before you ask what condition you’re treating.
Relative contraindications that call for clinical judgment
Not every caution on the list is a hard stop. Several situations require you to weigh benefit against risk, consult device labeling, or adjust parameters rather than cancel treatment outright.
Implanted electronic devices sit at the top of this category. A pacemaker or deep-brain stimulator does not automatically rule out ultrasound everywhere on the body, but thoracic application over a pacemaker is specifically discouraged, and FDA guidance recommends site-specific screening and consultation with the device manufacturer or the patient’s cardiology or neurology team before treating anywhere near the unit.
Metal implants and arthroplasties need similar nuance. Cemented hip arthroplasties using methylmethacrylate or high-density polyethylene have a higher coefficient of energy absorption, which raises the theoretical risk of cement loosening with ultrasonic diathermy, according to FDA’s guidance for ultrasonic diathermy devices. Bony-ingrowth implants without cement carry a different risk profile and are generally treated with more latitude, though manufacturer instructions still govern the decision.
Other factors that shift the calculus:
Impaired sensation or anesthetized skin, since patients may not report early overheating.
Anticoagulation therapy, which raises bleeding risk if tissue trauma occurs.
Compromised skin integrity, including recent scars or dermatitis in the field.
Pro Tip: When in doubt, drop the intensity, shorten the duration, keep the applicator moving continuously, and document the rationale in the chart before you start.
Why one contraindication list does not fit every ultrasound device
Contraindications shift depending on the device you’re holding. StatPearls makes this point directly: a contraindication list built for diathermy does not automatically apply to low-intensity pulsed ultrasound (LIPUS), focused ultrasound, or diagnostic imaging, because each uses different intensities, frequencies, and intended bioeffects.
Before applying any list, identify:
The modality category. Ultrasonic diathermy is built to heat tissue; LIPUS is used for bone healing at much lower intensities; diagnostic ultrasound is imaging-only; focused ultrasound is designed to concentrate energy at a specific depth.
The dose variables. Intensity, duty cycle, frequency, and total treatment time all change how much energy tissue absorbs and how forgiving the margin for error is.
The manufacturer’s labeling. Operator manuals are required to spell out contraindications, warnings, and precautions specific to that device, and following them is not optional.
A conservative rule of thumb across modalities is the ALARA principle, using the lowest effective exposure to achieve the clinical goal, a standard echoed in device labeling requirements and reflected in broader discussions of modality-specific safety in orthopedic therapy.
Pre-treatment screening and what to watch during the session
A short screening routine before every session catches most avoidable problems. Work through it methodically rather than relying on memory.
Confirm pregnancy status for anyone of childbearing age before treating the abdomen, pelvis, or low back.
Ask about active malignancy, infection, or recent bleeding in or near the treatment field.
Review vascular and bleeding history, including anticoagulant use and any known DVT.
Check for implants, cemented or otherwise, and for any implanted electronic device.
Assess pediatric patients for open growth plates before treating near a joint.
Test skin integrity and sensation in the treatment area.
Review current medications that might affect bleeding or sensation.
Once cleared, select parameters appropriate to the modality, choose a coupling medium suited to the applicator and body area, and keep the head moving throughout to avoid a stationary hot spot.
Screening step | What to check | Action if flagged |
Pregnancy status | Abdomen, pelvis, low back treatment | Avoid area, treat elsewhere or refer |
Implant review | Cemented arthroplasty, electronic device | Consult labeling or device team |
Sensation check | Numbness, anesthetized skin | Reduce intensity or avoid |
Skin integrity | Open wounds, recent scars | Avoid direct application |
Stop immediately if a patient reports burning, sharp pain, numbness, dizziness, chest discomfort, or any neurologic symptom, and document the parameters used along with the patient’s response.
Managing adverse events if something goes wrong
Most complications are preventable, but a clear response plan matters when one occurs.
Suspected burn or overheating: stop treatment immediately, cool the area, document the parameters and duration used, and arrange follow-up to monitor healing.
Suspected embolic event or DVT-related complication: treat as urgent, arrange same-day medical assessment, and do not attempt further treatment in that area.
Neurologic or cardiac symptoms during treatment: stop, monitor vital signs, and escalate to emergency evaluation if symptoms persist.
Device malfunction: preserve the unit and settings as they were, notify the manufacturer, and follow your institution’s incident reporting process.
What the growth plate evidence actually shows
A systematic review of therapeutic ultrasound and growth plates found only animal studies on the question, no human trials. At higher doses, the review found histologic changes including bone necrosis and inhibited growth, while lower doses produced transient stimulatory effects, and the authors recommend avoiding application around the physis despite the absence of reported human growth disturbance, a finding that supports caution rather than certainty. Absence of human harm reports is not proof of safety, and the practical stance for pediatric patients with open growth plates is to avoid direct treatment over the physis unless device-specific evidence supports otherwise, documenting the discussion and obtaining informed consent when treatment near a growth plate is genuinely necessary.
Bringing this checklist into daily outpatient practice
Screening for these contraindications is built into every walk-in visit, not treated as an extra step. Patients receive a review of pregnancy status, implants, skin integrity, and vascular history before any modality is chosen, and the device settings are checked against manufacturer labeling before each session. We encourage every clinic to adapt this checklist to its own devices, its own patient population, and its own institutional policy, since no single list replaces careful, site-specific judgment.
— James
Where to read the primary guidance
For full detail beyond this summary, consult FDA’s premarket guidance for ultrasonic diathermy devices, Health Canada’s Safety Code 23 excerpt, the StatPearls ultrasound therapy entry, and the growth plate systematic review. Always cross-check against your specific device’s labeling and your clinic’s protocols.
If you’re weighing whether ultrasound therapy or another modality fits your recovery plan, our team can walk through your history and current symptoms during an in-person visit. You can book an appointment online to get a personalized assessment before any treatment begins, and we welcome walk-ins for anyone who would rather stop by than schedule ahead.
This article is general information, not a substitute for advice from a qualified doctor. Consult a qualified healthcare professional about your own circumstances before acting on anything here.
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FAQ
What are the negative side effects of ultrasound therapy?
Reported issues include skin burns from excessive heating, worsened symptoms when applied over ischemic or infected tissue, and theoretical risks of clot dislodgement in patients with thromboembolic conditions. Most side effects trace back to incorrect screening or parameters rather than the modality itself, which is why pre-treatment screening matters as much as the treatment.
What precautions should be taken when using ultrasound therapy?
Clinicians should screen for pregnancy, active malignancy, infection, implants, and impaired sensation before treatment, then use the lowest effective exposure and keep the applicator moving to avoid hot spots. Device labeling and manufacturer instructions should guide parameter selection for every session.
Are there any contraindications to ultrasound?
Yes, absolute contraindications include the pregnant uterus, the eyes, active malignancy in the field, thromboembolic conditions, active infection, recent bleeding, ischemic tissue, open growth plates, and the thorax over a pacemaker, as outlined in FDA device labeling guidance. Relative contraindications, such as certain implants or anticoagulation, require clinical judgment rather than an automatic ban.
What are the potential downsides of using ultrasound in physiotherapy?
The main downsides arise when contraindications are missed: burns from overheating, potential harm near growth plates in pediatric patients, or complications near implanted electronic devices. Following a site-specific screening process before each session substantially reduces these risks.
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