No Significant Difference in Low-Back Pain Stratified Care Compared to Usual Care

A recent study out of Europe investigated the clinical efficacy and cost-effectiveness of stratified care, in comparison to the current practice for patients with non-specific low back pain (LBP).

It served as an updated version of the UK STaRT Back trial, which demonstrated stratified care’s superiority in improved clinical outcomes, reduced costs, and increased efficiency of healthcare delivery.

Investigators, led by Lars Morsø, University of Southern Denmark, Odense, adapted the trial to match Danish primary healthcare setting and guideline recommendations.

They found no differences in clinical outcomes between patients with non-specific LBP receiving stratified care, compared to usual care in Danish primary care.

Study

Investigators performed a two-armed, parallel-randomized controlled trial (RCT).

Participants were recruited between 2015 – 2017, with the last 12-month follow up questionnaire completed in December 2018.

Further, inclusion criteria included adults ≥18 years with non-specific LBP with or without associated leg pain.

Exclusions included serious pathology, serious illness or influential comorbidity, psychiatric illness, spinal surgery during last 6 months, pregnancy, or currently receiving physiotherapy for LBP.

In addition, data was collected at baseline, and then at 3- and 12-month follow-up after randomization.

For outcomes on the 3 most common domain of treatment success in LBP, investigators collected data from the patient-reported LBP Roland Morris Disability Questionnaire (RMDQ), time off work, and patient-reported global change.

Secondary outcomes included pain intensity, participant satisfaction, wellbeing, healthcare resource utilization, and quality-adjusted life years.

Results

After screening, investigators randomized 334 patients, half of the original intended number of study participants. Patients were allocated 1:1 to stratified care (n = 169) or current practice (n = 164)

At baseline, participants had a median age of 46 years, with 58% women. The team noted nearly one-third of patients had experienced LBP for more than 12 months.

Further, patients had a median pain severity score of 6 on a numeric rating scale of 0 – 10.

Investigators noted that the mean change in primary outcome of disability was similar in intervention and control arms at 3 months (5.9 versus 5.5) and 12 months (6.1 versus 6.5).

Thus, a non-significant mean score was found in RMDQ scores at 3 months (-0.5; 95% CI, -1.8 – 0.9) and at 12 months (0.4; 95% CI -2.1 to 1.3), with a mean difference of 0.1 (95% CI, -1.5 – 1.6)

At 3 months and 12 months, no overall differences were found in self-reported time off work, even in medium- and high- risk groups.

Investigators noted that the outcome of patient-reported global change showed small differences across arms.

At 12 months, differences between the intervention and the control arms were worse (6% vs. 9%), no change (32% vs. 32%) and better/much better (61% vs. 59%).

Investigators found that stratified care intervention resulted in fewer treatment sessions (3.5 versus 4.5), as well as lower total healthcare costs (13.4 versus 228, P = .002). They found no difference in cost-effectiveness.

Conclusion

The team concluded no differences were found in patients with non-specific LBP who received stratified care.

However, they noted that stratified care may result in fewer treatment sessions, as well as reduced costs related to prescription and x-rays.

“Although stratified care may be challenging to deliver, the SBT appears to have usefully informed clinical decision-making; this is in keeping with a previous study,” investigators wrote. “In the future, we would recommend assessing fidelity to the matched treatments and monitoring of the number of treatment sessions provided.”

The study, “Effectiveness of Stratified Treatment for Back Pain in Danish Primary Care: A Randomised Controlled Trial,” was published online in the European Journal of Pain.