Prolotherapy (prolotherapy) is an approach of injecting a solution, usually concentrated dextrose, into or around a joint, a tendon, a ligament, or the neighbouring tissue that has pain. This term covers diverse substances, positions, and techniques. Prolotherapy is not the same as plasma with a high concentration of platelets, treatment with stem cells, hyaluronic acid, or corticosteroid injection, so the evidence for those procedures should not be cited in place of one another.
The proposed mechanisms are a response to an irritant substance at that particular place and a change in the sending of pain signals, but they are still hypotheses. Calling prolotherapy "regenerative" does not prove that it creates new cartilage, makes ligaments strong, cures tendons, changes the course of the disease, or prevents injury in the future.
What does the evidence say
The evidence must be interpreted according to the diagnosis, the position of the injection, the substance used, the comparator, and the outcome wanted. The review by the Evidence Synthesis Program of the United States Department of Veterans Affairs (opens in a new tab) found important limitations in the research on prolotherapy with dextrose. The results differ according to the disease and the comparator, a great many pieces of work are small in size or at risk of bias, and the evidence on adverse effects is usually very uncertain.
For a degenerative knee joint, some comparisons indicate that the symptoms may improve, while others find little or no added benefit. The guideline of the American College of Rheumatology and the Arthritis Foundation (opens in a new tab) gives a conditional recommendation that prolotherapy should not be used for a degenerative knee or hip joint, because the trials are limited, the size of the effect is small, and the injection schedules, the injection positions, and the comparators differ greatly.
The evidence for chronic non-specific lower back pain, sacroiliac joint pain, abnormality of the tendon, heel pain, shoulder pain, and other diseases cannot be used in place of one another. The evidence does not support a blanket guarantee that it will create new tissue, relieve pain sustainably, or give superior recovery. Ultrasound may help a trained person see the anatomy and place the needle, but the precision of the position alone does not prove that the injection will make the important outcomes better.
Assessment must come before labelling someone as suitable for injection
Continuous pain is a symptom, not a tissue diagnosis by itself. The assessment should include the history, the examination, the limitations in function, the treatment received before, the medicines, and the patient's goals. Imaging may help when it is used to answer a clear clinical question, but an abnormality in an image does not identify the root cause of the pain or always prove that prolotherapy is suitable.
The doctor should consider other causes, such as inflammatory disease, infection, a fracture, cancer, abnormality of a nerve root or a peripheral nerve, pain referred from another organ, and the several factors that make pain persist. The words "lax", "degenerated", or "incompletely healed" are not safe selection criteria when used alone.
If prolotherapy is considered, there should be a preliminary diagnosis with reasoning, an explanation of the standard alternatives, and a plan for measuring the goals that matter to the patient. Suitability also depends on the position and the substance to be injected, the training of the person carrying out the procedure, the health and the wishes of the patient, and the readiness to follow up the result. There is no fixed injection schedule that can be used with every disease or every person.
Rehabilitation is still the core of the care
The main care for a great many chronic musculoskeletal problems consists of knowledge that can be understood, graded movement, exercise according to the disease, managing the load, and caring for sleep, work, mood, and other obstacles to doing activities. The World Health Organization guideline for chronic primary lower back pain (opens in a new tab) emphasises care that holds the patient as its centre and that is coordinated, rather than relying on procedures alone.
Injection should not replace progressive strength training, specific task training, or returning to meaningful activities when these are suitable. Rehabilitation is not evidence that the injection repairs tissue; it is a treatment in its own right. Activity after injection should be adjusted according to the diagnosis, the procedure, the symptoms, and the doctor's advice. A period of rest or a programme divided into phases should not be set the same way for everyone.
Which risks and health factors must be reviewed
The adverse effects may include a temporary flare-up of pain, bruising, bleeding, fainting, infection, an allergy or a reaction to the medicine, and injury to nerves, blood vessels, tendons, joints, or neighbouring organs. The risks depend on the position and the technique. Injection near the chest or the neck may cause complications that are met infrequently but are severe, such as a collapsed lung from air in the pleural cavity. Small trials not finding major complications does not prove that it is safe for every position or every person.
Before the procedure, an infection of the skin or throughout the body, fever, a state of bleeding easily, the use of anticoagulants or antiplatelet medicines, diabetes, abnormal wound healing, low immunity, pregnancy or breastfeeding, allergies, a history of reactions from injection, and all medicines and food supplements should be reported. These factors are not a single fixed set of contraindications, but may change whether the procedure is carried out, when, and how. Anticoagulants prescribed by a doctor must not be stopped without consulting the prescriber.
What should informed consent cover
Consent should be specific to the procedure proposed, covering:
- The preliminary diagnosis and the uncertainties that remain
- The exact substance, concentration, additives, position, and method of guiding the needle
- The evidence specific to the disease and the possibility of not improving or of the symptoms getting worse
- Reasonable alternatives, including rehabilitation or not injecting
- The common and the serious risks, the care after injection, and the plan for dealing with complications
- The costs expected, any conflicts of interest there may be, and use outside the approved indications
- The functional outcomes and the review points that will be used in deciding to change the plan
Consent is a shared decision, not a guarantee of a result. A set of injections or supplementary devices should not be presented as necessary if there is no evidence and no separate consent for each part.
Danger signals before or after an injection
New or increasing weakness of the limbs, numbness around the genitals or the buttocks, or loss of control of urine or faeces, must receive an emergency assessment according to the NICE guideline on cauda equina syndrome (opens in a new tab). Fever together with a hot swollen joint, a severe accident, unexplained illness throughout the body, or severe symptoms in the chest, the abdomen, or the nervous system, should also receive an urgent assessment rather than coming for the scheduled injection.
After an injection, urgent advice should be sought when the pain or the swelling increases rapidly, when redness spreads, when there is fever or shivering, when there is pus or discharge, when movement or bearing weight is impossible, or when new numbness or weakness arises. Call the emergency service when there is difficulty breathing, chest pain, loss of consciousness, a severe allergic reaction, or sudden neurological symptoms.
Questions before deciding
You should ask which diagnosis is being treated, what evidence matches that disease, what outcomes will be measured, and what alternatives there still are. Ask also who will carry out the procedure, how complications will be managed, how the rehabilitation will be continued, and what criteria would make the doctor stop rather than inject again.
There is no internationally standard number of prolotherapy sessions based on evidence. If there is no improvement, the diagnosis and the plan should be reviewed, not the intensity, the amount, or the supplementary treatments increased automatically.
In summary
Prolotherapy may be discussed as a choice for certain selected musculoskeletal diseases, but the evidence is specific to the disease and is usually uncertain. It should not be described as proven creation of new tissue, as changing the disease, or as a path that guarantees long-term recovery. Responsible care begins from the diagnosis and the accepted main treatment, has consent and risk screening specific to the procedure, maintains active rehabilitation, and assesses meaningful function before further injection