~ But surgery remains a popular option among patients.

04.06.2015

Patients with lumbar spinal stenosis who underwent surgical decompression showed similar improvements in physical function after 2 years compared with those who participated in physical therapy, researchers reported.

The study is the first to compare surgery and a standardized physical therapy program directly, wrote Anthony Delitto, PT, PhD, associate dean for research in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, in Annals of Internal Medicine.

“People need to find a way to truly exhaust their nonsurgical options,” Delitto told MedPage Today.

“By no means are we saying you shouldn’t have surgery for lumbar stenosis,” he said. “The decision to have surgery should be a shared one.”

But before deciding to have surgery, patients should understand that the long-term outcomes tend to become equivalent to not having surgery, he said. Patients should also be reminded of the higher risks associated with surgery.

The trial “suggests that a strategy of starting with an active, standardized [physical therapy] regimen results in similar outcomes to immediate decompressive surgery over the first several years,” wrote Jeffrey Katz, MD, director of the Orthopaedic and Arthritis Center for Outcomes Research at Brigham and Women’s Hospital in Boston, in an accompanying editorial.

“A substantial number of conservatively treated patients will elect surgery over this period, and they generally do well,” Katz wrote.

But “because long-term outcomes are similar for both treatments yet short-term risks differ, patient preferences should weigh heavily in the decision of whether to have surgery for [lumbar spinal stenosis],” he wrote.

Standardized Physical Therapy

A strength of the study was its use of definitions for non-operative treatment, Richard Skolasky, Sc.D., associate professor of orthopaedic surgery and physical medicine and rehabilitation and director of the Spine Outcomes Research Center at Johns Hopkins University, told MedPage Today.

In previous large, randomized studies, such as SPORT (Spine Pain Outcomes Research Trial), non-operative care was at the discretion of the surgeon and patient, Skolasky said.

“Surgical management is well-honed,” he added. “What is being done now is developing best practices for non-operative care.”

The study included 169 patients with a diagnosis of lumbar spinal stenosis identified by CT or MRI.

All patients were candidates for surgical decompression and had consented to surgery. Other inclusion criteria were the presence of neurogenic claudication and no previous surgery for lumbar spinal stenosis.

After patients had consented to surgery, they were randomized to receive surgical decompression or physical therapy for twice-weekly exercise sessions for 6 weeks. The follow-up period was 2 years.

On average, patients attended 8.4 physical therapy sessions (SD 4.6). Two-thirds of patients attended at least half of the prescribed 12 sessions.

Thirteen patients (16%) did not attend exercise sessions, and of those, 10 (77%) had surgery.

The physical therapy program included exercises in lumbar flexion and general conditioning, as well as patient education.

The primary outcome was physical function score on a self-reported survey (Short Form-36 Health Survey), which consisted of eight scaled scores ranging from zero to 100 that included pain, physical functioning, and mental health. Patients were assessed at 10 weeks, 6 months, 12 months, and 24 months.

There was no difference between the surgery and physical therapy groups in physical function scores at any time during follow-up.

The mean changes in change in physical function score for the surgery and physical therapy groups were 22.4 (95% CI 16.9-27.9) and 19.2 (95% CI 13.6-2.8), respectively.

In the surgery group, 61% of patients had a “successful” outcome at 2 years, compared with 52% of patients in the physical therapy group who did not cross over.

High Crossover to Surgery

Researchers limited crossover in the surgical arm by randomizing patients after they had already consented to surgery. All but two of the 87 patients assigned to surgery received surgery.

But 47 (57%) of the 82 patients assigned to physical therapy crossed over to surgery, with one-third occurring within the first 10 weeks. Of the crossover patients, 79% had received physical therapy, averaging a total of 7.8 sessions.

Crossover patients had higher pain and lower education levels but otherwise had similar demographics to non-crossover patients.

Patients crossed over from physical therapy to surgery for both medical and financial reasons, Delitto told MedPage Today.

Some patients had persistent neurogenic claudication. But others switched over because of the high copays for physical therapy sessions, which should raise questions about policy, he said.

“We all need to do a better job of making policy match evidence,” Delitto said. “When it’s more expensive out of pocket to do a more conservative treatment, then we should probably take a step back and look at policy issues related to caps and copays.”

Previous studies, including SPORT, had high levels of crossover in both arms, wrote Katz in the accompanying editorial.

“From a research standpoint, crossover from nonoperative to surgical treatment complicates analyses,” Katz wrote. “As-treated analyses may be biased because the comparison groups were not created by randomization but by patient and clinician preference,” he said.

Delitto and colleagues conducted an intention-to-treat analysis. Because of the high rate of crossovers in the physical therapy arm, they used a complier average causal effect and inverse probability weighting.

An additional limitation was treatment fidelity in the physical therapy group, Skolasky told MedPage Today.

Increasing treatment adherence should be emphasized in future research, he said. “I think more work needs to go into augmenting the skills the patients have to be active members in healthcare,” he added. “Patients are not passive recipients of care … A lot of heavy lifting falls on patients and their families.”

• Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

LAST UPDATED 04.07.2015