We now take a look at a couple of more spine surgeries; lumbar discectomy and spinal stenosis surgery. Lumbar discectomy is the most common operation performed in the US for lower back related symptoms due to the fact that lumbar disc herniation is the most prevalent cause of sciatica (radiating nerve root pain). The literature suggests that lumbar discectomy provides effective clinical benefit in carefully selected patients with sciatica. There is strong evidence in favour of microdiscectomy surgery over conservative treatment at short-term follow up, but it has a high failure rate over time. This is due to two primary causes; recurrence of symptoms associated with reherniation and chronic or worsening back pain. Overall, the long-term benefits of surgery versus non-operative treatment are still unclear. One systematic review conducted in 2010 tried to shed light on which treatment would be more beneficial for patients with sciatica due to lumbar disc herniation. Management of sciatica varies considerably. Patients are commonly treated in primary care but a small portion is referred to secondary care and may eventually undergo surgery if complaints remain present for at least 6 weeks. There seems to be a consensus that surgery is helpful in carefully selected patients for sciatica in presence of a herniated lumbar disc or sever sciatica. The primary rationale for surgery for sciatica is that it will relieve nerve root irritation or compression due to herniated disc material. There is evidence that early surgery in patients with sciatica provides for better short-term relief of leg pain as compared to prolonged conservative care, but the evidence is low quality because only one trial investigated this properly. Future studies need to be done to evaluate who benefits from surgery and who from conservative care.
Lumbar spinal stenosis is the most common condition leading to spine surgery for patients over the age of 60. Spinal stenosis of the lumbar spine typically produces pain, cramping, numbness, weakness, pins and needles feeling in the legs that is worse with walking and better with resting or leaning forward. Spinal stenosis is generally not progressive and the pain tends to come and go. The management of spinal stenosis by surgery has increased rapidly in the past two decades, however there is still controversy regarding the efficacy of surgery for this condition. Surgery for lumbar spinal stenosis should only be considered if a patient’s ability to participate in everyday activities is compromised and a concerted effort to relieve symptoms through non-operative means has been exhausted. A few systemic reviews have been done but all found during their research that no trials could be identified comparing surgery to no treatment or placebo/sham surgery. It would seem that along with the other types of spine surgeries we have investigated, there is relatively limited evidence to guide the use of surgery for the management of lumbar spinal stenosis until more adequate testing has been conducted.
References
Chin, Lawrence S. “Lumbar Discectomy.” Medscape. 22 September 2015. http://emedicine.medscape.com/article/1999923-overview
Jacobs, Wilco C.H., Van Tulder, Maurits, Arts, Mark, Rubenstein, Sidney M., Van Middelkoop, Marienke, Ostelo, Raymond, Verhagen, Arianne, Koes, Bart, Peul, Wilco C. “Surgery versus conservative management of sciatiac due to a lumbar herniated disc: a systematic review.” European Spine Journal. 29 September 2010. http://link.springer.com/article/10.1007/s00586-010-1603-7
Machado, Gustavo C., Ferreira, Paulo H., Harris, Ian A., Pinheiro, Marina B., Koes, Bart W., Van Tulder, Maurits, Rzewuska, Magdalena, Maher, Chris G., Ferreira, Manuela L. “Effectiveness of Surgery for Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis.” PLOS. 30 March 2015. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122800
Ullrich, Peter F., “Lumbar Spinal Stenosis Surgery Options.” Spine-health. 10 May 2011. http://www.spine-health.com/conditions/spinal-stenosis/lumbar-spinal-stenosis-surgery-options
Zaina F, Tomkins-Lane C, Carragee E, Negrini S. “Surgical versus non-surgical treatment for lumbar spinal stenosis.” Cochrane. 29 January 2016. http://www.cochrane.org/CD010264/BACK_surgical-versus-non-surgical-treatment-lumbar-spinal-stenosis
Zigler, Jack. “When to see a Surgeon for Spinal Stenosis.” Spine-health. 15 January 2009. http://www.spine-health.com/conditions/spinal-stenosis/when-see-a-surgeon-spinal-stenosis
Evidence Is Mounting Against the Benefits of Surgery
In both orthopaedic surgery and sports medicine, it is unclear whether some surgical interventions are better than non-surgical alternatives or better than placebo in the form of sham surgery (faked surgery in which the part of the procedure thought to be therapeutically necessary is not done). Recent examples where surgical interventions were shown to have no benefit over non-operative alternatives or sham surgery include arthroscopic surgery in middle aged and older people with persistent knee pain, surgical reconstruction of acute rupture of the anterior cruciate ligament in young active adults, and vertebroplasty to treat pain associated with vertebral fractures. First up under the scope; knee surgeries.
The case continues to mount around the lack of evidence to support arthroscopic surgery for degenerative knees in middle-aged or older patients with knee pain with or without signs of osteoarthritis. The evidence for such surgery has always been weak, only one clinical trial has reported that it benefits patients, yet many surgeons continue to perform the procedure. Arthroscopic knee surgery is considered to be minor surgery but it is not without its risks, including infections and blood clots. In 2015, a team of Danish and Swedish researchers released a major new systematic review of 9 previously published clinical trials that compared arthroscopic knee surgery to either exercise treatment or placebo/sham surgery. The studies involved a total of 1,270 participants aged 49 to 62. The reviewers found that both exercise and arthroscopic surgery had a small effect on reducing knee pain, but that the benefit from the surgery disappeared after 6 months. The pain-relieving benefit that the patients received from arthroscopic surgery for a few months was comparable to taking an over-the-counter pain medicine and significantly less than the effect seen from exercise therapy for knee osteoarthritis. The study also pointed out that arthroscopy is associated with a particular long-term risk; an increased likelihood of developing osteoarthritis. Another important factor noted was patients with previous knee surgery underwent total knee replacement at a significantly younger age than patients without previous knee surgery.
Surgical management of ACL reconstruction is a topic that has been at the forefront of orthopaedic discussion and debate for many years. Recommendations for which patients should have the surgery have evolved and continue to be modified. People who have torn their ACL have to make some tough decisions right after confirming the diagnosis; whether to have surgery to reconstruct or repair the ligament or whether to try rehab and physical therapy first. Traditionally, doctors have steered patients toward having the surgery straight away with the hope that a fast repair can prevent some of the long-term consequences of ACL tears which include osteoarthritis and tears of the meniscus. But a study published in the New England Journal of Medicine in 2010 was the first to question that notion. They concluded that many patients who first try a course of physical therapy to get back on their feet after an ACL tear wind up with the same improvements in pain and function 2 years down the road as those who had immediate surgery. People with minor ACL tears and middle aged people who don’t do as much activity can be helped with non-surgical means and avoid surgery altogether. It seems like it’s very hard to justify immediate ACL surgery unless you are a young, high level competitive athlete.
Even with the mounting evidence against knee surgeries, it still looks to be an uphill battle in reversing these practices. The main factors providing resistance are surgeon confirmation bias in combination with financial aspects and administrative policies. We can only hope that one day surgeries won’t be the go-to fix but a last resort when all other therapy and care has been exhausted.
References
Davis, Jennifer. “Study Finds No Benefit in Immediate Surgery for ACL Tears.” Arthritis Foundation. 22 July 2011.www.arthritis.org/living-with-arthritis/treatments/joint-surgery/types/knee/acl-tears-delay-surgery-physical-therapy.php.htm.
News Now Staff. “More Evidence Questions Benefits of Arthroscopic Knee Surgery.” PT in Motion. 18 June 2015. www.apta.org/PTinMotion/News/2015/6/18/BMJArthroscopic.htm.
Perry, Susan. “Common surgery for knee pain has no long-term benefits, only risk, study finds.”
MINNPOST. 18 June 2015. https://www.minnpost.com/second-opinion/2015/06/common-surgery-knee-pain-has-no-long-term-benefits-only-risks-study-finds.htm.
Next, we take a closer look at vertebroplasty and its effectiveness. Vertebroplasty is a common treatment option for people with severe osteoporosis. It involves injecting medical-grade cement into a fractured vertebra through a needle inserted into the skin. The cement then hardens in the bone to form an internal cast. The risks of vertebroplasty are generally low but unwanted effects can occur. After 24 hours of bed rest, most people can return to normal, non-strenuous activities. Surgeries like vertebroplasty are not subject to the same rigorous evaluation as prescription drugs and medical devices which must be approved by the U.S. Food and Drug Administration before they’re made available. In fact, surgical procedures can become the standard of care long before any well-designed, peer-reviewed studies are completed, and government regulatory bodies generally do not get involved. This lack of reviews from regulatory bodies makes it really easy for these types of surgeries to become the norm when they might actually not be doing any good.
The latest studies conducted on the efficacy of vertebroplasty were done in 2009. They were the first randomized, double-blinded trials designed to compare vertebroplasty with sham procedures and placebos. Their results contradicted clinical experience and surprised the medical community. The studies, one at the Mayo Clinic in Minnesota and the other in Australia, produced similar results. They found that vertebroplasty for pain relief performs no better than sham procedures using placebos and local anesthesia. The results were so surprising that the lead researcher of the Mayo Clinic trial, Dr. David F. Kallmes, even felt compelled to question his study’s data. Kallmes and his colleagues weren’t seeking to debunk the value of vertebroplasty they just wanted to better comprehend the benefits. He believed the research would put aside the doubts of vertebroplasty’s efficacy. What it did was raise more questions than answers and led many in the medical field to question the assumptions about vertebroplasty and other evidence-based medicine.
To really understand if there are actual benefits from performing vertebroplasty, more carefully crafted prospective and randomized clinical trials need to be done. Indications to treat have become too wide and lax but by conducting randomized, blinded, and prospective trials, the medical community can move forward in finding the best possible procedure to benefit the patient.
Another spinal surgery that started out with positive results, only to turn negative once more studies were conducted is spinal fusion using bone morphogenetic proteins. BMPs stimulate bone growth naturally in the human body. These proteins that exist in the body can be produced, concentrated, and placed in the area of the spine for a spinal fusion to take place. Since the first commercial BMP became available in 2002, a host of research has supported BMPs and they have been rapidly incorporated into spinal surgeries. However, recent controversy has arisen surrounding the ethical conduct of the research supporting the use of BMPs.
Early positive results led to FDA approval of BMPs for use in human surgery. Although they limited the use of BMPs to lumbar spinal fusion it was found that off-label use was rampant. Furthermore, a majority of early studies were industry sponsored and performed by surgeons with high levels of investment in the success of BMP. As more independent research becomes available, it’s clear that early studies were flawed in their research design and biased in their outcomes. The Spine Journal reviewed all of the past publications regarding BMPs and found a higher incidence of side effects or adverse effects than previously published research suggested. The specific complications that drew the most concerns included swelling in the neck and throat, radiating leg pain, and male sterility. Controversy remains despite the widespread use of BMPs and will only be put to rest once further research and clinical trials are conducted that provide positive evidence for the use of BMPs in spinal fusion. Spinal surgeons should remain aware of current research in order to practice current evidence-based procedures.
References
Buchbinder R, Golmohammadi K, Johnston RV,Owen RJ,Homik J, Jones A, Dhillon SS, Kallmes DF, Lambert RGW. “Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.” Cochrane Database of Systematic Reviews. 30 April 2015. http://www.cochrane.org/CD006349/MUSKEL_vertebroplasty-for-osteoporotic-vertebral-compression-fractures.htm
Burke, Stephanie. “Side Effects for Human Bone Morphogenetic Protein Use.” Spine-Health. 1 August 2011. http://www.spine-health.com/blog/side-effects-human-bone-morphogenetic-protein-use.htm
Harvey, Dan. “Vertobroplasty – Sorting Things Out When Studies Conflict With Clinical Experience.” Radiology Today. June 2010. http://www.radiologytoday.net/archive/rt0610p24.shtml.htm
Hustedt, Joshua W. and Blizzard, Daniel J. “The Controversy Surrounding Bone Morphogenetic Proteins in the Spine: A Review of Current Research.” Yale Journal of Biology and Medicine.
12 December 2014. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4257039/.htm
Rehan, Kelly. “How Effective is Vertebroplasty?” Spine Universe. 24 August 2015. http://www.spineuniverse.com/conditions/osteoporosis/how-effective-vertebroplasty.htm
Scott, Jennifer Acosta. “Back Pain: Can a Kyphoplasty or Vertebroplasty Help?” Everyday Health. 8 July 2013. http://www.everydayhealth.com/pain-management/back-surgery-kyphoplasty-vertebroplasty-spinal-cord-pain.aspx.htm
Ullrich, Peter F. “BMP: Bone Morphogenetic Proteins.” Spine-Health. 25 November 2009.
http://www.spine-health.com/treatment/spinal-fusion/bmp-bone-morphogenetic-proteins.htm
Physiotherapy is the core treatment for patients with spinal, and musculoskeletal problems. Physical therapy interventions may include: Spinal and extremity manipulation; therapeutic exercise; electrotherapeutic and mechanical agents; functional training; provision of aids and appliances; patient education and counseling; documentation and coordination, and communication.