Get Back, a person-centred digital programme targeting physical activity for patients undergoing spinal stenosis surgery-a study protocol of a randomized feasibility study

Emelie Karlsson; Rikard Hanafi; Helena Brisby; Andreas Fors; Mike Kemani; Håkan Hedman; Jo Nijs; Mari Lundberg

doi:10.1186/s40814-023-01433-9

Get Back, a person-centred digital programme targeting physical activity for patients undergoing spinal stenosis surgery-a study protocol of a randomized feasibility study

Pilot Feasibility Stud. 2024 Jan 26;10(1):16. doi: 10.1186/s40814-023-01433-9.

Authors

Emelie Karlsson¹, Rikard Hanafi^{2

3

4}, Helena Brisby^{5

6}, Andreas Fors^{7

8

9}, Mike Kemani^{2

4

10}, Håkan Hedman⁸, Jo Nijs^{3

11

12}, Mari Lundberg^{2

3

7

8}

Affiliations

¹ Back in Motion Research Group, Department of Health Promoting Science, Sophiahemmet University, Box 5605, 114 86, Stockholm, SE, Sweden. emelie.karlsson@shh.se.
² Back in Motion Research Group, Department of Health Promoting Science, Sophiahemmet University, Box 5605, 114 86, Stockholm, SE, Sweden.
³ Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, 1050, Brussels, Belgium.
⁴ Karolinska University Hospital, Theme Women's Health and Allied Health Professionals, Medical Unit Medical Psychology, Solna, Sweden.
⁵ Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁶ Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁷ Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁸ University of Gothenburg Centre for Person-Centred Care (GPCC), Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁹ Region Västra Götaland, Research, Education, Development and Innovation, Primary Health Care, Gothenburg, Sweden.
¹⁰ Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
¹¹ Chronic Pain Rehabilitation, Department of Physical Medicine and Physiotherapy, University Hospital Brussels, 1050, Brussels, Belgium.
¹² Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Abstract

Background: Spinal stenosis is the most common reason for elective spine surgery, and the cardinal symptom is leg pain and discomfort when walking. Patients with spinal stenosis have a decreased level of physical activity and thereby an increased risk of poor health. Get Back is a person-centred digital programme that strives to support patients being physically active after surgery. The aim is to explore if Get Back, in its present format (referred to as Get Back_feasibility), is feasible and contributes to detectable change in variables related to intervention content.

Methods: Thirty patients planned for decompression surgery due to central lumbar spinal stenosis who present with low physical activity, pain catastrophizing or fear of movement, will be included in a randomized feasibility study. All patients will be randomly allocated to either Get Back_feasibility or usual physical therapy. Get Back_feasibility aims to increase the patient's physical activity level by combining a person-centred and cognitive behavioural approach. It comprises 10 video and telephone sessions led by a physical therapist over 12 weeks (pre/postoperatively). Outcomes are treatment fidelity (treatment dose, adherence, and content), process feasibility (recruitment, intervention use, and acceptability of measurements and intervention), and variables related to the intervention content (steps per day, physical activity level, pain catastrophizing, fear of movement, and general self-efficacy). Treatment fidelity and feasibility data will be assessed during the full study period (12 weeks). Physical activity, physical capacity, and patient-reported outcomes will be assessed digitally at baseline (2 weeks preoperatively) and 11-12 weeks postoperatively. Variables related to the intervention content will be monitored weekly through a digital application. Feasibility data will be analysed descriptively and inferentially using a nonparametric approach, data from repeated measures will be displayed graphically and data from telephone interviews will be analysed using content analysis with a descriptive manifest approach.

Discussion: The results will provide information on whether Get Back in its present format is feasible and can be evaluated for effectiveness in a larger randomized controlled trial, for patients with a low physical activity level and a high fear of movement who are undergoing decompression surgery.

Trial registration: Registered at ClinicalTrails.gov 04/08/2023, registration no. NCT05806593.

Keywords: Feasibility; Physical activity; Physiotherapy; Spine disease; eHealth.

Associated data

ClinicalTrials.gov/NCT05806593

Abstract

Associated data

Grants and funding