We see more and more patients calling us these days who finally have a few local options for bone marrow stem cell therapy for their orthopedic problems. As the original clinic in the U.S. doing this work, we applaud this expansion of options for patients. However, we also continue to hear from patients that physicians are performing these procedures without any type of imaging guidance. Imaging guidance means that the doctor can see where the needle is going. This is doubly important in the procedure used to harvest the stem cells: a bone marrow aspiration. While many physicians who are just starting to use bone marrow stem cells to treat things like knee, shoulder, hip, ankle, and hand/foot problems may believe they can take an accurate bone marrow aspirate without knowing where the needle is located, a simple anatomy review will show why this isn’t the case. Above you can see a slice through the PSIS area of the back of the pelvis (near the dimples of Venus). This is the most common bone marrow aspiration site to obtain stem cells. Note that the red arrow points to a section of the bone that’s paper thin and that the green arrow points to an area where it’s very thick. These areas are very close together, such that a needle that happens to get into the thin area will get no bone marrow (which is located inside the bone), but simply go through and through the bone, leading to a slow draw of blood that contains few of the stem cells sought. However, a needle that is guided to the correct thick area can easily tap into the bone marrow space and collect stem cells. How did we learn this? 5 years ago as we started to culture cells, we learned it the hard way. A sample from the thin area produced no measurable cells in culture, while a needle into the thick area produced good cultured stem cells. The upshot? When taking bone marrow, a “blind” procedure (without fluoroscopic or ultrasound guidance) is likely to sometimes collect no stem cells. In addition, since the bedside centrifuges used by many physicians have no way to measure what’s obtained (unlike a full level 3 lab), the doctor never knows he’s just taken a bad sample that won’t help the patient, as a bad sample looks just like a good sample!
Have you had this experience? You see your orthopedic surgeon who spends a few minutes performing an exam, looks at your films, and suggests shoulder surgery. But do you really need shoulder surgery? Are there much less invasive options? Is there a shoulder surgery alternative? While we often treat many smaller rotator cuff tears and other shoulder problems with stem cells, we also believe that some shoulders don’t even need that level of care. Many patients will get better by getting rid of myofascial trigger points with an IMS technique. Never heard of this therapy? You’re not alone. I explain trigger points and IMS it in more detail in our medical practice’s book, Orthopedics 2.0. Briefly, muscle trigger points are spots in the muscle that become painful and locked, so that the muscle is painful and weak. These spots can be simply cleared by a well trained provider with an acupuncture needle (however IMS isn’t Chinese acupuncture). Now a new study published by one our colleagues shows that IMS is effective in a randomized controlled trial. The results of the study showed that a three month program of IMS is more effective than no treatment. Based on experience, I would say that many of these patients with simple shoulder muscle trigger points often get unnecessary surgery. Why haven’t you heard of this very valuable treatment that is much less invasive than surgery? The economics of medicine. Trigger point injection therapy (either Travell type with the injection of anesthetic or IMS) don’t pay well, so these therapies have become a lost art. However, apparently a lost art that’s effective and based on the low invasiveness of the technique, in our opinion, far safer than surgery.
Interesting study last month on the use of a specific type of platelet rich plasma-PRFM (platelet rich fibrin matrix), which is more commonly used in surgery. Instead of a cell suspension, PRFM is more like a dense fibrin clot that has platelets embedded inside. In this study, two groups of shoulder rotator cuff repair patients were studied, one where PRFM was used and the other without-no differences in outcomes between the PMRF and usual group were found in this study. My personal take on the research would be that surgical repair for small and medium sized rotator cuff tears isn’t always recommended (which the study authors commented on by saying PRFM might work for larger tears). Another issue with PRFM is you tend to get an unusually dense fibrin matrix (a very thick and dense clot, different from the soft gel that naturally occurs with a blood clot). This dense matrix is a bit more like fibrin glue. The problem with dense clots (like fibrin glue) is that mesenchymal stem cells have difficulty migrating through the clot, and are more likely to perish. Since MSC’s would be the likely cells stimulated by the platelets to enhance repair, the dense clot of PRFM may have worked against these researchers.
You might think that with about 40,000 shoulder rotator cuff tear repair surgeries performed in the United States each year, that there was solid medical evidence supporting that this type of shoulder surgery was effective. However, a recent published review by Agency for Healthcare Research and Quality looked at more than 150 published papers and concluded that there was no solid evidence that rotator cuff surgery benefited patients more than no surgery. Huh? We’re operating on shoulders at a furious pace and we don’t know for sure whether the operations help patients more than not operating? Medicine is like any other field, at some point an idea takes hold and spreads like wildfire. In this case the idea was that sewing the torn shoulder rotator cuff back together was a good idea. It may still be in some patients. However, sewing a shoulder rotator cuff tear means prolonged immobilization as you have to substantially weaken the area through shoulder surgery before you can get it to heal. This type of long-term inactivity for the rotator cuff muscles and tendons can lead to shoulder rotator cuff atrophy and/or a weaker, but healed rotator cuff tendon. Add to that research showing that many patients never regain full range of motion after a shoulder rotator cuff tear surgery, likely due to the same immobilization and prolonged bracing needed to get the shoulder rotator cuff to heal, and it starts to make sense that the research doesn’t support that shoulder surgery is more effective than no shoulder rotator cuff tear surgery. So what to do? Shoulder surgery or no shoulder surgery? We tell our patients that if you have a massive tear and have otherwise good healthy tissue and are an active person who will benefit from working rotator cuff muscles, then surgery may be your best option. However, on the other hand, if you have a partial rotator cuff tear or a full thickness rotator cuff tear without retraction (the two ends pulled apart), then you should consider non-surgical injection based repair rotator cuff strategies rather than shoulder surgery. These injections allow the patient to be more active during recovery and hopefully this increased activity will allow the patient to have a stronger and more functional shoulder rotator cuff repair when compared to a more invasive shoulder surgery.
It would make sense at face value, that you would want to completely immobilize a torn rotator cuff to let it heal. After all, this is the way bones heal best. The problem is that studying rotator cuff tear healing in an animal model can be difficult. Animals hate to be immobilized and often there’s no good way to immobilize them that’s anything like what we would use in a human. So some creative scientists came up with another way, they injected Botox to paralyze the rotator cuff muscle-the ultimate shoulder immobilizer! Regrettably, what happened is what often happens in today’s model of rotator cuff healing, while the tears healed quickly, the resulting healed rotator cuff tendon was weaker than tendons that healed on their own. This fits with other research on shoulder rotator cuff tears that atrophy of the rotator cuff muscles (the muscles shrink and become weaker due to disuse), is associated with a worse outcome from shoulder rotator cuff surgery. It turns out that we need activity to stress the healing rotator cuff tear area to allow it to heal strongly. For a massive rotator cuff tear this means gradual return to activities, but regrettably, while the months spent in a blue pillow shoulder immobilizer will help the sewn pieces heal, the repair will be less than optimal due to weakness in the tissue (hence the high re-tear rate for shoulder rotator cuff surgical repairs). For partial tears of the rotator cuff that won’t heal on their own, we believe in procedures that let the patient be as active as they feel able, as this will produce the stongest repair. For our clinic, this means injections to help the torn rotator cuff heal with activity, rather than sewing the area back together. Letting the patient move and use the shoulder while the rotator cuff heals, based on this and other research, all things being equal, will likely produce a stronger repair of a torn rotator cuff tendon.
Rotator cuff tears can be difficult to heal and shoulder surgery can have high complication rates. In addition,rotator cuff repair surgeries are often associated with long recovery and rehab times (think blue pillow immobilizer). Here we present a case of a patient (EZ) who had a 2-3 year history of shoulder pain and after an MRI was told he needed surgery to repair the rotator cuff tear. The patient was a physical therapist, so he knew about shoulder rotator cuff tear non-surgical options and wanted to try and avoid more invasive surgery. Shoulder rotator cuff tear injected under active ultrasound guidance shown here. The patient underwent the Regenexx-PL and Regenexx-SCP injection procedures. These two are different and this will be a good discussion of the differences. Regenexx-PLis platelet lysate-our doctors crack open the platelets to get all of the important growth factors out to be immediately available to the stem cells. This is different than PRP (platelet rich plasma) which has intact platelets and acts as a timed release of growth factors. While PRP (platelet rich plasma) can be very helpful at times, when getting stem cells to grow, our lab experiments have shown that PRP under performs platelet lysate. The Regenexx-SCP procedure uses a lab processed platelet preparation where the smaller blood circulating stem cells are preserved. The result? The images above are from an ultrasound of the shoulder (sagittal cuts with a Sonosite M-Turbo in MSK mode). The pre-treatment pictures are on the left (same pictures stacked on the left-one annotated for problems in the bone and one annotated for problems in the muscle). On the right, again the same image stacked, from two months after the first image. Note the break in the bone and the rotator cuff tear in the pre-treatment images and then the repair of the bone and much less prominent rotator cuff tear in the post-treatment images. The patient now reports no pain in the front of the shoulder with movement overhead. Throwing a softball and playing volleyball is now not painful. Overall improvement is noted at 90%.
Fascinating, but not surprising study, weighing in on the belief by many physicians (and patients) that x-ray or MRI findings are good at explaining why a patient has pain-in this case focused on shoulder x-ray findings. It might surprise most people to learn that the width of the cartilage remaining in their shoulder joint or the amount of bone spurs doesn’t correlate to pain or function, meaning patients with little joint width left or many bone spurs were no more likely to have pain or lost function than those without those findings. This fits with many other studies in the knee and low back that show the same thing: findings on imaging studies such as MRI and x-ray often don’t tell us why the patient hurts. In the knee for example, 60% of middle aged or elderly patients with meniscus tears had pain and 60% of patients with meniscus tears had no pain. This whole concept needs to start changing our approach to orthopedic care as I have discussed in our practice’s book on regenerative medicine and stem cells-Orthopedics 2.0. We as physicians need to stop believing that a picture is a substitute for a good history and comprehensive physical exam. As doctors, our thumbs are often better (a hands on exam) at determining where the pain might be coming from than an MRI.
What was interesting about the study was that one bone spur did correlate with lost function. This is the bone spur at the bottom of the shoulder joint often seen in patients with advanced shoulder arthritis. This makes sense, as this bone spur would retrict lifting the arm up and above the head, as it would get in the way of the ball moving downward in the socket as the arm moves upward. We’re beginning to work on non-surgical solutions for removing this bone spur using barbotage, to see if getting rid of this spur through a needle may help these patients have better shoulder ranage of motion without the need for surgery.