Get Back, a Person-centred Digital Program Targeting Physical Activity for Patients Undergoing Spinal Stenosis Surgery - a Randomized Feasibility Study

Status: Completed
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients planned for decompression surgery (no fusion) due to central lumbar spinal stenosis

• reporting a low level of physical activity (do not meet WHO´s physical activity recommendations of minimum 150 min moderate intensity per week), and one of the following criteria at preoperative screening; fear of movement (Tampa Scale of Kinesiophobia (TSK) ≥ 37) and/or pain catastrophizing (Pain Catastrophizing Scale (PCS) \>30).

Locations
Other Locations
Sweden
Ryggkirurgiskt centrum Stockholm
Stockholm
Capio Spine Center Göteborg
Västra Frölunda
Time Frame
Start Date: 2023-04-17
Completion Date: 2024-11-04
Participants
Target number of participants: 29
Treatments
Experimental: Intervention (Get Back pilot)
The intervention includes 5 core sessions (video call) and 5 booster sessions (telephone) over 12 weeks (1 week before until 11 weeks after surgery). All sessions will be led by a physiotherapist. The focus of each core session (1-5) is as follows:~1. To establish the patient as an active, equal partner in the treatment and to formulate a shared health plan according to person-centred care.~2. To reduce the threat value of postoperative pain and increase the patient's knowledge about the biopsychosocial nature of pain and positive effects of physical activity.~3. To detect barriers for postoperative physical activity and to support the patient to gradually start increasing physical activity.~4. To increase approach behavior for physical activity and reduce avoidance behavior by confronting fears and move towards personal goals.~5. To support the patient to independently continue with activity progress towards long term health and to formulate a maintenance plan.
No_intervention: Control (standard physiotherapy)
The control group will follow standard physical therapy, meaning physical therapy as it is provided at each recruiting site when undergoing surgery due to spinal stenosis. As this may differ substantially between clinical sites nationally, data on frequency of physical therapy and the content of the physical therapy sessions during the study period will be collected as a control variable weekly from the control group.
Related Therapeutic Areas
Sponsors
Collaborators: AFA Insurance, The Swedish Research Council
Leads: Sophiahemmet University

This content was sourced from clinicaltrials.gov