Get Back, a person-centered digital program to promote physical activity among patients undergoing spinal stenosis surgery: a randomized feasibility study.

BACKGROUND

Lumbar spinal stenosis is characterized by walking limitations that often lead to physical inactivity and potentially associated health risks. This trial aimed to examine whether a person-centered digital program targeting physical activity (Get Back feasibility) was feasible and whether it contributed to clinically meaningful improvements in intervention outcomes among patients with LSS who were undergoing surgery.

METHODS

A two-arm randomized feasibility trial included physically inactive patients ≥ 18 years with central lumbar spinal stenosis scheduled for decompression surgery. The participants were randomized to Get Back or usual physical therapy. The 12-week intervention comprised person-centered support for behavioral changes in physical activity through video and telephone calls with a physical therapist. The feasibility outcomes included process feasibility, resource feasibility, and treatment fidelity, based on data from screening lists, study-specific questions, patient-reported outcome measures, and semi-structured interviews. The outcomes related to the intervention content included objectively assessed steps per day and physical activity, as well as self-reported fear of movement, pain catastrophizing, and general self-efficacy. Process and resource feasibility, as well as tentative changes in post-intervention outcomes, were assessed and reported using descriptive statistics. The temporal relationships of variables during the intervention were analyzed exploratively using cross-lagged correlations. Treatment fidelity, including treatment dose and adherence to the person-centered approach, was evaluated using descriptive statistics and a mixed-methods approach, respectively.

RESULTS

Of the 226 screened patients, 43% (n = 98) fulfilled the screening criteria. Of those, 67 were asked to participate, and 29 were randomized. The most common reason for declining participation was not wanting a digital intervention. The participants found the video format and outcome measures relevant and useful. The response rates were high (92-100%), except for the accelerometer follow-up (76%). The planned primary outcome for the future randomized controlled trial, steps per day, showed tentative between-group differences in favor of the intervention group. In both groups, fear of movement and pain catastrophizing decreased. The intervention participants attended four video sessions and a median of four telephone sessions (3-5). The physical therapists performed the intervention as planned, with fidelity to the person-centered approach, and behavior-change techniques were used.

CONCLUSIONS

Get Back was feasible for patients with lumbar spinal stenosis who were receiving decompression surgery, with some modifications to strengthen the overall study procedure and intervention before proceeding to a full-scale randomized controlled trial.

TRIAL REGISTRATION: Registered at ClinicalTrials.gov, 04/08/2023, registration no. NCT05806593.