Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial

Abstract

Background: Clinical experience suggests that many patients with Modic changes have relatively severe and persistent low back pain (LBP), which typically appears to be resistant to treatment. Exercise therapy is the recommended treatment for chronic LBP, however, due to their underlying pathology, Modic changes might be a diagnostic subgroup that does not benefit from exercise. The objective of this study was to compare the current state-of-the art treatment approach (exercise and staying active) with a new approach (load reduction and daily rest) for people with Modic changes using a randomized controlled trial design.

Methods: Participants were patients from an outpatient clinic with persistent LBP and Modic changes. They were allocated using minimization to either rest therapy for 10 weeks with a recommendation to rest for two hours daily and the option of using a flexible lumbar belt or exercise therapy once a week for 10 weeks. Follow-up was at 10 weeks after recruitment and 52 weeks after intervention and the clinical outcome measures were pain, disability, general health and global assessment, supplemented by weekly information on low back problems and sick leave measured by short text message (SMS) tracking.

Results: In total, 100 patients were included in the study. Data on 87 patients at 10 weeks and 96 patients at one-year follow-up were available and were used in the intention-to-treat analysis. No statistically significant differences were found between the two intervention groups on any outcome.

Conclusions: No differences were found between the two treatment approaches, 'rest and reduced load' and 'exercise and staying active', in patients with persistent LBP and Modic changes.

Trial registration: ClinicalTrials.gov: NCT00454792.

Figure 1

Classification of size. Classification of the size of a Modic change (MC) based on its depth of extension into the vertebral body height: A: Endplate only, B: > endplate to 25%, C: 25 to 50%, and D: > 50%. Only patients with B, C or D met this inclusion criterion for the current study.

Figure 2

Flowchart. Flow of patients referred to the project and included in the interventions, together with an overview of dropouts and the reasons for this.

Figure 3

SMS-Track of low back problems. SMS-Track data showing means and CI for number of days with low back problems for both groups. The CI of the rest group is colored grey and is visible behind the transparent pink CI of the exercise group.

Figure 4

SMS-Track of days on sick leave. SMS-Track data showing means and CI for number of days on sick leave for both groups. The CI of the rest group is colored grey and is visible behind the transparent pink CI of the exercise group.