Orthopaedic medicine has a long history and many tools with which to help the patient with musculoskeletal pain. In this Issue I would like to review basic principles regarding Prolotherapy for the benefit of physicians who are developing skills in Prolotherapy (Regenerative Injection Therapy )and PRP and as a review for those already practicing these skills. In order to achieve the greatest success, the procedure should be performed correctly enhancing safe practices and limiting risk for the patients. Several important elements need attention: practice management (consent, documentation, billing and coding issues), assessment and identification of appropriate candidates for the procedure and safe performance of the procedure itself.
Knowledge of the pathology behind the patient’s complaint.
Identify the problem based on history, physical examination and imaging studies. Look for local tender points, as well as distal referral points. Remember, the initial presentation of pain could be referred pain and not necessarily where the problem is. Learn common patterns of referred pain. Become familiar with the diagnosis of instability of joints based on the clinical symptoms and exam findings. Make the correlation between clinical findings and imaging studies. Remember: Imaging studies do not always correlate with clinical findings and vice versa.
Knowledge of anatomy and function. Do your homework before treating the patient. Read anatomy, so you will know what are you are doing. Proficient prolotherapists are perpetual students of anatomy. Have diagrams, posters and anatomical illustrations readily available in your exam rooms. Show your patients where the problem is and how you will treat it.
Inform the patient about the procedure in detail. Give them realistic expectations of the treatment and prognosis. Explain to the patient that prolotherapy is a PROCESS and requires multiple treatments and time to see results. Give the patient an option to review other possible treatments: Physical therapy, Surgery, OMT, and especially the options offered as standard of care for their particular diagnosis. Informed consent requires that the patient be presented the standard of care alternatives for their diagnosis.
Documentation of Informed Consent is just as important as the signature. Have the patient sign a detailed consent form, explaining all possible side effects and complications. The potential side effects and complications should be discussed and outlined to the patient and documented on the consent form. You may wish to have your forms reviewed by your malpractice carrier to be certain they meet the standards. Encourage the patient to contact you before the scheduled procedure and to ask questions. When examining elderly patients advise them to come with close relatives or friends so that all questions will be answered and not missed. Informed consent must list the standard medical options the patient was informed of and chose not to pursue.
Have the patient sign all medical and financial documents with the co-signature of a witness-your nurse or other office assistant.
Know important medical information pertinent to safe performance of an invasive procedure: Medical history, Medications list, Previous surgeries, Allergies, Presence of prosthesis, hardware, screws and plates. Discuss with referring physician the procedure you are going to perform. If you advise the patient to stop any medications ask the PCP for permission to do so. Do not discontinue medications ordered by other doctors without consulting with them first. Do not criticize other physicians or previous treatments. You also may not be the last doctor. Strive to create a professional and healing atmosphere in your treatment room.
Never use old solutions. All solutions must be mixed on the day of the procedure. Aseptic technique must be taken very seriously. In some cases you may consider prophylactic antibiotics. Proper positioning of the patient is very important. It must be safe for the patient and comfortable for physician performing the procedure. Consider IV line and VS monitoring in some cases. Make sure you are ready for medical emergencies. If you chose to use conscious sedation or pre-medicate your patients be sure they have a driver and that you meet the regulations of your state and malpractice carrier for conscious sedation or premedication.
Prepare skin for procedure. If the skin is inflamed in the area the injections are to be performed it is better to postpone the treatment. Again, know your anatomy and be very careful while injecting:
Midline of the vertebrae: direct needle caudate
Avoid cranial direction.
Be careful injecting midline below L3–Interspinal ligaments could be absent and risk for dural perforation is high.
Always touch the bone.
In some cases, aspirate before injecting, especially the transverse processes of cervical spine.
Be very careful around chest/rib/thoracic injections and lower cervical spine – risk for pneumothorax.
Check the function of the treated area after the procedure: ROM, pulsation, lungs sounds and vital signs.
Post Procedure: Offer patients fluids and snacks if necessary. Some patients will be light headed or vasovagal from the sympathetic stimulation of the injections. Give patients time for full recovery. All patients must be instructed to come with a designated driver. Make sure that you will be readily available to the patient after the procedure – give them you mobile phone number. It is a very beneficial practice to call your patient the next morning, especially after the first injection session. This is reassuring to the patient and allows you to evaluate their response to the treatment.
Documentation is a necessary part of the job of the physician. Make it simple, but detailed. Forms with diagrams, flow sheets with check boxes or items to circle can ease the documentation process for procedures. The following should always be present:
General information about Prolotherapy for patients as well as their physicians.
Detailed consent form
Financial disclosure and agreement
Preparation for Prolotherapy
Patient Response to the procedure
Taking the time to review these processes and implement safe processes and procedures as you introduce new techniques into your practice will facilitate safe practices for you and good outcomes for your patients.