by Shara Yurkiewicz, Staff Writer, MedPage Today 2014-09-15

Action Points

Patients with back-related leg pain who received spinal manipulative therapy (SMT) plus home exercise and advice (HEA) had less leg pain, lower back pain, and disability after 12 weeks than patients who received home exercise and advice alone, researchers reported.

At 1 year, those differences were no longer significant, wrote Gert Bronfort, DC, PhD, at Northwestern Health Sciences University in Bloomington, Minn., and colleagues in a study appearing in Annals of Internal Medicine. But patients experienced more global improvement, higher satisfaction, and lower medication use, the researchers reported.

The findings suggest that SMT in addition to HEA could be a safe and effective conservative, short-term treatment approach for back-related leg pain, the authors said.

“Prior to this study, SMT was considered a viable treatment option of what is known as ‘uncomplicated low back pain,’ which is low back pain without radiating pain to the leg,” authors Bronfort and Roni Evans, DC, PhD, at the University of Minnesota in Minneapolis, wrote in an email to MedPage Today.

“This study shows that for patients without progressive neurological deficits and serious identifiable causes (e.g., spinal fracture, etc.) SMT, coupled with home exercise and advice, may be helpful, and should be considered,” they added.

“If we can find less invasive means to get relief and avoid surgery, that’s always a good thing,” David Geier, MD, an orthopedic surgeon in Charleston, S.C., who was not involved with the study, told MedPage Today.

“In the early phase where there are restrictions in motion, then anything that tries to get that process moving forward is useful,” Gerard Malanga, MD, a physiatrist specializing in sports medicine and pain medicine at Rutger’s University-New Jersey Medical School in Newark, who also had no role in the study, told MedPage Today.

But he cautioned that passive treatment was not a long-term solution.

“The strongest medical literature out there that has been repeated decade after decade is to try to keep patients as active as possible,” Malanga said. “If these measures help to facilitate that, great. But patients should not be placed in a prolonged course of treatments that are passive in nature.”

Unclear Patient Population

Limitations in study design may prevent the findings from being applicable to particular patients, Christopher Standaert, MD, a physiatrist specializing in nonoperative spine and musculoskeletal care at the University of Washington in Seattle, told MedPage Today.

Study researchers defined back-related leg pain as “a constellation of symptoms characterized by radiating pain originating from the lumbar spine and traveling into the proximal or distal lower extremity with or without neurologic signs.”

“Back-related leg pain is a diverse group of entities,” said Standaert, who was not involved with the study. Causes include nerve root involvement from disc herniation, spinal stenosis, spondylolisthesis, cysts, or scoliosis. But trochanteric bursitis, hamstring injuries, problems with the sacrum, and vascular claudication that mimics neurogenic claudication can also cause back and leg pain, he added.

“I have a hard time understanding the patient population — what [researchers] did to diagnose them, how they determined what might or might not be appropriate to do,” he said. “They lumped a lot of distinct clinical entities with well-understood natural histories and pathophysiologies into the same category and threw a blanket treatment at them, which is not a good way to treat people.”

Without a clear diagnosis, there could be dangers to spinal manipulation, Standaert said. For example, spondylolisthesis with vertebral instability would not be appropriate to manipulate.

The study’s exclusion criteria included pain without radiation into the lower extremities, progressive neurologic deficits, cauda equina syndrome, spinal fracture, spinal stenosis, surgical lumbar spine fusion, several incidents of lumbar spine surgery, chronic pain syndrome, visceral diseases, compression fractures or metastases, blood clotting disorders, severe osteoporosis, and inflammatory or destructive tissue changes of the spine.

Benefits From SMT or Other Factors?

The 192 patients in the study with subacute or chronic back-related leg pain were randomized into two groups: those receiving SMT along with HEA and an HEA-alone group.

For 12 weeks, patients worked with chiropractors, exercise therapists, and a personal trainer to receive the HEA program, which was given in four 1-hour, one-on-one visits with patients and included instruction and practice to enhance mobility and increase trunk endurance.

In the SMT group, a patient could receive as many as 20 SMT visits, each lasting 10 to 20 minutes. These involved manual techniques, including high-velocity, low amplitude thrust procedures or low-velocity, variable amplitude mobilization maneuvers to the lumbar vertebral or sacroiliac joints. They also received adjunct therapies as needed, such as active and passive muscle stretching, ischemic compression of tender points, and hot or cold packs.

In both groups, the mean number of HEA visits was roughly the same: 3.8 (SD 0.6; median 4.0) in the SMT group and 3.6 (SD 1.0; median 4.0) in the HEA group.

The mean number of SMT visits was 14.6 (SD 3.8; median 16) in the SMT group.

The primary outcome measure was patient-rated leg pain on an 11-point scale. At 12 weeks, the SMT group had significantly improved pain compared with the HEA group (difference of 10 percentage points, 95% CI 2 to 19, P=0.008).

Those in the SMT group also fared significantly better in terms of lower back pain (P=0.005), disability (P<0.001), global improvement difference (P≤0.02), and satisfaction (P<0.001) at 12 weeks.

At 52 weeks, the SMT group sustained better global improvement and satisfaction. A total of 42% of patients in the SMT group were using medication for leg or back pain, compared with 66% of the HEA group. No significant differences were seen in the primary endpoint or in lower back pain or disability with 1-year follow-up.

Standaert said the improvements in the SMT group could be due to other factors besides the SMT itself.

“One group got 15 visits with a provider during the treatment period,” he said. “One thing that is clear from low back pain literature is that doing something is always better than doing nothing. Providing care, providing advice, providing recommendations to move, providing support of any sort … when you physically do something with your patient, they will feel better for a little while.”

Bronfort and Evans defended the use of adjunct therapies in the SMT group. “This trial was designed to be pragmatic in nature and reflective of how SMT is commonly delivered in practice,” they wrote in an email. “The trial was NOT designed to isolate the specific effects of SMT alone. So we do not view the adjunct therapies as ‘confounding.’ Rather we view them as part of the normal package of care which one can expect when they receive SMT, making the intervention generalizable to clinical practice.”

The placebo effect could also play a role in improved outcomes, said Geier.

At baseline, the SMT group had higher expectations for treatment than the HEA group (9.0 on a 10-point scale, compared with 7.6).

But baseline expectations were not correlated with outcomes and therefore did not need to be controlled for in the statistical analysis, Bronfort and Evans told MedPage Today. “We conducted qualitative interviews with all patients in the study to examine their expectations more fully; these are currently being analyzed and will be published at a later date,” they added.

Primary Source

Annals of Internal Medicine

Source Reference: Bronfort G, et al “Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain” Ann Intern Med 2014; 161: 381-391.

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