It’s clear that shoulders aren’t the most durable body part when it comes to, well, shouldering the workload of moving us through this world. That’s made obvious by the staggeringly high incidence of largely untreatable injuries in people with SCI who use manual wheelchairs. New research at New Jersey’s Kessler Foundation offers some hope.
Recently, a group of researchers based in New Jersey published promising preliminary results from a small trial to test a minimally-invasive, long-lasting treatment for manual wheelchair users who live with ongoing shoulder pain that doesn’t seem to respond to other alternatives. It consists of carefully harvesting a person’s own fat and processing it to yield micro-fragmented adipose tissue (MFAT), which is then injected into the required location in the shoulder joint using precise ultrasound guidance.
The use of adipose tissue as a treatment dates back at least to World War I; there are written accounts of battlefield surgeons packing autologous (which means the donor and the recipient are the same person) adipose tissue into open wounds in the hopes of preventing infection and accelerating the healing process. In the last few decades, there has been growing research interest in the potential for adipose tissue to repair injured or damaged tissue. One company that has emerged as a leader in this space is Milan-based Lipogems International, which has developed its own patented MFAT transplantation process. It’s been tested for safety, and in 2018, the FDA approved it for some orthopedic and arthroscopic procedures—for example, with arthritis in the knee. But it’s never been tested for the specific purpose of treating the injured shoulders of people with SCI who use manual wheelchairs—until now, that is.
The study was led by Dr. Trevor Dyson-Hudson, who, as a physician and Director of the Center for Spinal Cord Injury Research at New Jersey’s Kessler Foundation, specializes in the restoration of function and mobility after SCI, as well as treatment of SCI secondary complications. (As an aside, he is also a C6 quadriplegic.)
The results, while not conclusive, are promising and suggest that MFAT transplants could be an effective treatment for chronic shoulder pain.
“The idea to explore the use of MFAT as a possible treatment for chronic shoulder pain in persons with SCI really originated with my colleague, Dr. Gerry Malanga,” explains Dyson-Hudson. “Dr. Malanga is a physiatrist, sports medicine physician, and Director of the New Jersey Regenerative Institute. I have known him since I first started at Kessler 22 years ago—he was one of my mentors. We had collaborated on a similar study investigating the safety and efficacy of platelet-rich plasma (PRP) injections for chronic shoulder pain in persons with SCI. The results from that study were promising, so I was in the process of applying for more money to do a larger clinical trial with PRP when Dr. Malanga suggested doing one in MFAT instead.” Malanga’s rationale was that results from larger clinical trials of PRP in able-bodied persons were a mixed bag—some showed PRP was more effective than standard therapies such as physical therapy or corticosteroid injections, but others studies showed no difference.
“Dr. Malanga had started offering MFAT injections as an alternative to PRP injections and bone marrow cell injections in his private practice based on promising results he had seen in able- bodied persons with shoulder and knee injuries,” says Dyson-Hudson. “He suggested that, rather than continuing down the path with PRP, we consider doing an exploratory study to look at the feasibility, safety, and effectiveness of MFAT injections in persons with SCI who had chronic shoulder pain.”
Dyson-Hudson agreed, and the researchers (there are five on the team) recruited ten participants for the study. All had an SCI, used a manual wheelchair, and had chronic shoulder pain. The preliminary results, published in the May 13 issue of Spinal Cord Series and Cases, did not summarize the entire trial; it was a case report that focused only on the first study participant to complete the study, a 54-year-old man who had sustained a T10 complete injury ten years ago.
The participant, who wishes to remain anonymous, is an active manual wheelchair user and avid weight lifter. For three years prior, he had complained of chronic pain in both shoulders that was unresponsive to traditional treatments.
“He is a very active individual who had been severely hampered by shoulder pain the last few years,” says Dyson-Hudson. “He had undergone surgery in one shoulder a few years earlier with disappointing results—the pain was coming back—and he was now doing repeated steroid shots to treat the pain in the other shoulder. The steroids would relieve the pain for a couple of months; however, it would always come back and he would have to get another injection to relieve it. Remember that repeated steroid injections are not recommended if it can be avoided—over time, they can actually damage tendons and interfere with healing. He really didn’t want to do another surgery, so wanted to see if there were alternatives.”
The researchers proceeded with Lipogems treatment of his right shoulder only. The first step involved ultrasound and MRI examinations, which revealed a rotator cuff tear and degenerative changes of the acromioclavicular joint, one of the joints that’s located at the top of the shoulder. The participant’s own fat was then harvested and processed using the Lipogems system to yield sufficient MFAT. This was then injected into key locations of shoulder, with the needle carefully guided by ultrasound.
For the first four days after the treatment, he minimized weight-bearing activity with the shoulder. He was then instructed to slowly increase his normal everyday upper-limb weight-bearing activities, using pain as his guide. He also began a functional rehabilitation program at home 24 hours after the procedure, which started with stretching and progressed to include strengthening exercises after one month.
The results were eye-opening. Dyson-Hudson and his colleagues used a variety of scientifically-validated tests to measure the participant’s post-injury progress.
He reported almost immediately following the treatment that his pain and discomfort were significantly lessened, and his ability to perform activities of daily living improved.
His test scores continued to improve as months passed by. After one year, he remained pain-free and maintained his functional improvements. Not only that, the rotator cuff tear had shrunk by 50 percent when scanned with MRI.
“We were all excited and a little bit amazed at seeing the positive results and surprised that improvements were sustained even one year after the injec- tion,” says Dyson-Hudson. “Not only did test scores improve, but the participant’s function improved too, which is much more important. We often base treat- ment need and success on what images show, such as those from MRI. However, results from images—the signs of tissue pathology—don’t necessarily correspond to pain levels or levels of lost function. What’s really important is how people feel and how they function.”
There were no adverse side effects reported by the patient.
As for the other nine participants…
“Not all have seen the same dramatic results the first participant saw—two had no change in shoulder pain,” says Dyson-Hudson. “However, the majority have had significant decreases in shoulder pain and significant improvements in shoulder function even one year after their MFAT injection in those we’ve seen.”
So just how exactly is MFAT improving shoulder health and mobility? Dyson-Hudson says the exact mechanisms aren’t yet known conclusively, but he and other researchers in the area agree that it’s helping in at least two ways.
“Adipose tissue can provide cushioning that supports and allows tissue to heal,” he says. “There may also be growth factors and/or groups of cells within the adipose that may help strengthen remaining tissue such as tendon or cartilage, or help with healing.”
Despite the positive results, the researchers did issue some cautions in their first paper. The first is that the results summarized and published to date are for only one of the ten participants. The researchers also concede that, aside from the measurable improvement in the tendon tear, the results are somewhat subjective—in other words, they are based on the perception of pain by the participant. As such, there is the potential for a possible placebo effect.
As well, the MFAT injection was accompanied by needling of the tendon, which has shown some therapeutic effect for the treatment of tendon inflammation. “Results could be from the needling of the tendon itself or placebo, because they’re getting an intervention that is pretty involved and their expectations and hopes are high that they will get better,” he says. “However, these are people who have tried other treatments such as physical therapy and steroid injections for their chronic shoulder pain for at least six months, and those treatments didn’t work, or only worked for a little while before the their shoulder pain came back. In our study, of the first eight participants who reached their one-year follow-up point, six of them still experienced significant improvements in pain.”
The researchers also concede that the formal stretching and strengthening programs provided to each participant to complement the MFAT treatment have also shown benefits all by themselves in some people with SCI reporting chronic shoulder pain. However, they also point out that the study participants’ untreated shoulders continued to be painful, in spite of the fact that the strengthening and stretching regime was done with both arms.
A final concern is that, while the tendon tear had clearly shrunk, other MRI-observed damage didn’t improve—for example, the original inflammation in several tendons remained unchanged at 12 months. However, it’s entirely possible that this means the most powerful benefit of MFAT transplantation could be its ability to reduce inflammation and pain signalling, as opposed to outright structural repair.
Clearly, a more rigorous trial with more participants is needed to confirm the promising results and rule out other explanations for the improvement. That will happen sooner rather than later, as Dyson-Hudson and his colleagues have been approved for funding to conduct a MFAT transplantation safety and efficacy study in 28 wheelchair users with SCI who have chronic shoulder pain.
We’ll attempt to wait patiently for science to take its course. But we can’t help but be excited by the prospect of the preliminary results being replicated and confirmed—and the potential for a new standard of care for chronic shoulder pain to emerge for our readers and others with SCI all around the globe.
You can read more information about Dr. Dyson-Hudson and his work on the Kessler Foundation website.
This article first appeared in our Fall 2019 issue of The Spin and has been edited for our blog. Read the full version alongside other stories, including:
- Accessible Gaming
- The Breast Experience: Properly Fitting Bras
- Cabin Fever: BC Parks Debuts Accessible Cabins
- and more!
