NCT05806593: GetBack

Feasibility of a Person-centred Digital Program Targeting Physical Activity in Spinal Stenosis Surgery

Completed NA Last updated 18 December 2024

What this trial tests

NA trial testing Get Back pilot in Spinal Stenosis Lumbar in 29 participants. Completed in 4 November 2024.

Timeline

17 April 2023

Primary endpoint
4 November 2024

4 November 2024

Quick facts

Lead sponsor	Sophiahemmet University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	29
Start date	17 April 2023
Primary completion	4 November 2024
Estimated completion	4 November 2024
Sites	2 locations across Sweden

Drugs / interventions tested

• Get Back pilot

Conditions studied

• Spinal Stenosis Lumbar — all drugs for Spinal Stenosis Lumbar →

Sponsor

Sophiahemmet University

Who can join

18 and older, any sex, with Spinal Stenosis Lumbar. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal stenosis is the most common cause of degenerative spinal surgery. The majority do not achieve the global recommendations for health-promoting physical activity before or after surgery. Patients with a low level of physical activity and a high degree of fear of movement are at an increased risk of poorer health outcomes after surgery. Increasing the number of steps per day is a way to increase physical activity, which in long term can lead to health benefits. In addition, a digital format is a way to increase the availability of physiotherapy to strive for equal rehabilitation.

The overall purpose of the research project is to improve health outcome and increase the availability of rehabilitation for patients at high risk of negative health outcomes after spinal surgery due to spinal stenosis through Get Back, a person-centered and digital program with a focus on physical activity.

Before conducting a large-scale study, the investigators want to conduct a study that aims to investigate and develop the Get Back program regarding content and dose, treatment fidelity as well as feasibility in terms of study procedure, compliance, and acceptability.

Approximately thirty patients with lumbar spinal stenosis and an identified risk profile for poorer postoperative outcomes will be recruited from two spine clinics in Sweden. The program involves meeting a physiotherapist digitally (through video call) approximately 1 week before surgery to formulate a person-centered health plan. The health plan is monitored and progressed by the physiotherapist by video until eleven weeks after surgery. The Get Back program includes 5 sessions (1 hour each) which are supplemented with 5 booster sessions (30 minutes) to reinforce the intervention. Get Back is based on three key components that run through all sessions. These are person-centeredness, behavioral medicine techniques to reduce fear of movement and worries about pain, as well as to optimize physical activity. The physiotherapist supports the participant's individual resources and abilities through validated behavioral medicine methods in combination with education/communication/knowledge support and behavior-strengthening tools (which are also used in-between sessions) to achieve the participant's personal goals linked to physical functioning, physical activity, and health. The program will be compared to standard physiotherapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Get Back, a person-centered digital program to promote physical activity among patients undergoing spinal stenosis surgery: a randomized feasibility study.
   Ernest C, Hanafi R, Brisby H, Fors A, et al · · 2026 · PMID 42026690 · DOI 10.1186/s40814-026-01826-6
2. Get Back, a person-centred digital programme targeting physical activity for patients undergoing spinal stenosis surgery-a study protocol of a randomized feasibility study.
   Karlsson E, Hanafi R, Brisby H, Fors A, et al · · 2024 · PMID 38279131 · DOI 10.1186/s40814-023-01433-9