Extended Informed Consent - When a Standard Treatment Consent Isn't Enough

A physiotherapist performs dry needling on a patient's trapezius muscle. The patient had earlier signed a general consent form for therapy -- the same one every new patient signs at their first visit. After the treatment she experiences a brief vasovagal syncope, falls, and suffers a head injury. During the investigation, the patient's representative argues that the form only mentioned "consenting to physiotherapy" -- it said nothing about dry needling, nothing about the risk of fainting, nothing specific at all. The court has to assess whether the patient was actually informed about the risk of the SPECIFIC technique that was used on her.

This is a scenario that recurs in case law involving patient rights -- and it shows why a single, universal consent form, good enough for most treatments, stops being sufficient the moment you reach for a technique carrying elevated risk. This article is a natural continuation of the topic we already covered in patient consent for a physiotherapy treatment -- here we focus exclusively on situations where a basic consent stops protecting the physiotherapist and an extended, written, and detailed consent is needed.

The line between implied consent and written consent

Articles 17-18 of the Polish Act on Patient Rights leave little room for discretion regarding the form of consent for elevated-risk treatments. Article 17 states that a patient (or their legal representative) has the right to consent to specific health services. Article 18 goes further: consent for a treatment that carries elevated risk for the patient must be given in written form, after the patient has first been informed of the type, purpose, expected benefits, and possible consequences of that treatment.

In the day-to-day practice of a physiotherapy clinic, this line looks like this:

• Standard low-risk treatments (relaxation massage, therapeutic exercise, kinesiotherapy, heat/cold therapy, electrotherapy at typical parameters) -- implied or verbal consent is sufficient. The fact that the patient books an appointment, shows up, and undergoes the treatment after its course has been explained is treated as consent being given. It's still worth noting this in the records, though.
• Elevated-risk treatments -- the law requires written form, not merely recommends it for evidentiary reasons. This is a meaningful difference compared to basic consent, where written form was mainly a safeguard in case of a dispute. Here, the absence of written consent for an elevated-risk treatment is a violation of the Act in itself, regardless of how the treatment turned out.

The key question, then, is which physiotherapy treatments qualify as "elevated risk." The Act doesn't provide a closed list -- it's a clinical judgment -- but in practice a few categories of treatment come up regularly in this context.

Treatments that warrant an extended consent

The table below lists typical elevated-risk physiotherapy techniques along with the main reason they require a separate, written extended consent -- a general "I consent to physiotherapy" form is not enough here.

Treatment / situation	Why it's elevated risk	What the extended consent should cover
Shockwave therapy (ESWT/RSW)	Pain during and after the treatment, possible bruising, contraindications (pregnancy, clotting disorders, tumors in the treated area)	Description of the shockwave mechanism, list of contraindications, typical reactions after treatment
Dry needling	An invasive technique -- breaks the continuity of the skin with a needle	Risk of bruising, brief pain, vasovagal syncope, in rare cases pneumothorax (near the chest area)
HVLA manipulations (spine)	A high-velocity, low-amplitude technique with risk of neurological and vascular complications	Description of the technique, rare but serious risks (e.g. vascular complications of the cervical spine), contraindications
Patient with osteoporosis	Increased fracture risk with manual techniques and mobilizations	Note the diagnosis, adjust the technique, describe the elevated fracture risk
Patient on anticoagulants	Increased risk of bleeding and extensive bruising with invasive techniques and deep massage	Note the medication, describe the bleeding risk, possible consultation with the treating physician
Pregnant patient	Some techniques and treatments are contraindicated or require modification	Note the pregnancy and week, list of excluded techniques, description of adjustments

The common denominator in all these situations is that a standard consent -- written for "typical" physiotherapy -- doesn't address the specific risk of the given technique or the patient's specific health situation. And that specificity is exactly what Article 18 of the Act on Patient Rights requires.

Why a generic consent doesn't protect you against a claim

A form with one sentence -- "I consent to physiotherapy" -- is convenient: it's signed once, at the first visit, and in theory covers everything that happens afterwards in the clinic. The problem is that such a document doesn't meet the requirement of informed consent under the law when an elevated-risk technique is involved.

Informed consent means the patient was informed about a specific treatment, its specific course, and its specific risk -- not physiotherapy "in general." In a court dispute or before the patient ombudsman, what matters isn't that the patient once signed some form. What matters is whether the content of that form shows the patient was informed precisely about the risk that materialized.

[SP] Example -- Solo practice: A physiotherapist running a one-person practice regularly performs dry needling on patients with myofascial conditions. Until now he used the same general consent form he uses for every other treatment. After reading this article, he introduces a separate "Consent to dry needling" checkbox describing the specific risk (bruising, brief pain, rare vasovagal syncope) and has patients sign it before their first treatment with this technique -- regardless of the fact that they already signed a general therapy consent.

[GR] Example -- Group practice: At a practice employing four therapists, each one uses a different set of elevated-risk techniques -- one performs HVLA manipulations, another shockwave therapy. Instead of one universal form, the practice owner introduces a set of checkboxes at patient registration: a separate checkbox for each elevated-risk technique, with a short risk description under each one, plus a procedure requiring the therapist to confirm the relevant checkbox has been checked and signed before using that technique on a patient for the first time.

The solution, then, is to move away from a single general form toward checkboxes for specific treatments -- each with a separate, understandable risk description, signed before the first use of that technique on a given patient. This solves two problems at once: first, the patient actually reads a short, specific description (instead of ignoring a long general policy document); second, the records retain a trace that the patient was informed precisely about the risk that actually threatened them.

How to describe risk in the form so it actually protects you

Written form alone isn't enough if the risk description is worded generically ("the treatment may involve some discomfort"). A consent only protects the physiotherapist against a claim when the risk description is specific and understandable to the patient -- not medical jargon, but language an average patient can understand.

A few rules worth applying when drafting the risk description:

• List concrete, realistic side effects -- e.g. for dry needling: bruising, brief pain at the insertion site, in rare cases vasovagal syncope. Writing "possible adverse effects" is not enough.
• Distinguish common risks from rare but serious ones -- the patient should know that bruising is normal and common, while fainting is rare but possible. Hiding rare, serious risks behind a general phrase weakens the evidentiary value of the consent.
• Avoid purely legalistic language -- the consent needs to be understandable to the patient at the moment of signing, not just formally correct. A court may assess whether an average patient could understand what they were signing.
• Note the patient's questions and the answers given, if the patient asked anything before the treatment -- this is additional evidence that the informing process actually took place, rather than being reduced to handing over a sheet of paper to sign.
• Update the form as knowledge changes -- if new evidence about a technique's risk emerges, the consent form should be periodically reviewed and updated, as we describe in the article on medical records in physiotherapy.

A well-constructed extended consent form is simultaneously a legal protection tool for the physiotherapist and real support for the patient in making an informed decision -- these two goals aren't in conflict, even though the form is often seen mainly as "protection in case of a dispute."

Which techniques require additional caution regarding qualifications

Not every physiotherapist is qualified to use all the elevated-risk techniques listed above. Dry needling and some manual techniques require additional certifications and courses, whose scope and requirements we cover in detail in the article on qualifications for dry needling and manual therapy. Extended consent doesn't replace qualifications -- these are two separate requirements that must both be met: the physiotherapist must be legally entitled to use the given technique, and the patient must give informed, written consent to its use.

Frequently asked questions

Does extended consent replace the basic consent to therapy?

No, these are complementary documents, not substitutes for one another. Basic consent covers the general start of therapy and standard low-risk treatments, while extended consent covers a specific elevated-risk technique and must be signed additionally, before that technique is used on a given patient for the first time.

Does extended consent need to be signed before every treatment, or just once?

The Act doesn't specify this explicitly, but good practice is to sign the extended consent before the first use of a given technique on a patient, and then note in the records at each subsequent session that the patient is continuing therapy on the same terms. If the patient's health status changes (e.g. they start taking anticoagulants) or the treatment parameters change significantly, it's worth obtaining consent again.

What happens if there's no written consent for an elevated-risk treatment, even if nothing went wrong?

The lack of the required written form for an elevated-risk treatment is a violation of Article 18 of the Act on Patient Rights in itself, regardless of whether a complication occurred. In practice, this creates a risk of a complaint to the patient ombudsman, or a much weaker evidentiary position for the physiotherapist if the patient later files a claim related to that specific treatment.

Does the TARCZA package include a ready-made extended consent form for specific treatments?

The TARCZA package includes a basic treatment consent template (instructions and form) that serves as a solid starting point -- but not the treatment-specific extended version described in this article. Forms for specific elevated-risk techniques (dry needling, HVLA, shockwave therapy) currently need to be adapted yourself based on the basic template, adding a risk description specific to each technique.

CTA: The TARCZA package gives you a basic treatment consent template as a starting point for building your own extended consent forms -- together with the complete HACCP/GMP documentation required in a physiotherapy practice. See FizjoReady packages →

Related articles:
- Patient consent for a physiotherapy treatment -- template
- Dry needling and manual therapy -- what qualifications are required
- Medical records in physiotherapy