Clinical trial NCT05806593: Feasibility of a Person-centred Digital Program Targeting Physical Activity in Spinal Stenosis Surgery
Official title: Get Back, a Person-centred Digital Program Targeting Physical Activity for Patients Undergoing Spinal Stenosis Surgery - a Randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis Lumbar
Keywords: Health promotion
Person-centred care
Physical activity
Behavioral medicine
Telehealth
Lead sponsor: Sophiahemmet University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: AFA Insurance
First posted: 2023-04-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Get Back is developed based on a prior person-centered prehabilitation program for patients undergoing lumbar fusion surgery. The prior program showed good effect on the patient's health directly after the intervention, had a high adherence rate and was found to be safe. The prior program was, however, conducted on a relatively healthy and young group (age 46 years). Get Back aims to expand this program to include patients with lumbar spinal stenosis (LSS), who are at risk of negative health outcomes after surgery. Get Back will be delivered by e-health (video calls) as prior face-to-face interventions have identified barriers for participation by long travel distances to the rehabilitation centre. The program will focus on health promotion throughout the whole perioperative period in contrast to previous programs that have focused on reducing disability. Get Back will target for example walking behavior with the aim to increase the patients' physical activity (primarily assessed by steps per day as a proxy), as it is associated with a progressively lower risk of all-cause mortality. Before the investigators start a full scale randomized controlled trial, a feasibility trial will be conducted to assure and refine the evaluation design and the intervention, recommended by The Medical Research Council (MRC).

Participants will be recruited from two private spine clinics located in two different regions. Patients will be clinically examined by an orthopaedic surgeon, who will make a medical diagnosis based on the clinical and radiological findings. If a surgical decision is made and the patient is placed on the waiting list, a physiotherapist will contact the patient meeting inclusion criteria and screen for the risk profile as well as provide the information about the study and ask for participation. As the intervention is fully digital the patient information in written will also be sent to the patient digitally. Inclusion and exclusion criteria are described under paragraph 10.

The primary study aim is to explore if Get Back can provide a detectable change in variables related to the intervention content (steps per day, physical activity level, as well as variables related to pain catastrophizing, fear of movement, and self-efficacy) and to evaluate treatment fidelity as well as feasibility in terms of trial procedure, compliance, and acceptability. A randomized feasibility study (n=30) with multiple measures will be conducted in preparation for a future two-arm multicenter randomized controlled trial.

At baseline, approximately 2 weeks before surgery, all participants, will meet with an independent observer digitally (video call) who will collect demographic data, and conduct a few physical function tests. The patient will fill in patient reported outcome measures (PROMs) digitally. An accelerometer will be sent out to the study participant through mail to wear for 7 days. A study coordinator will then allocate the patients to either the Get Back pilot (n= 15) or standard physiotherapy (n= 15) based on a computerized random list converted to concealed envelopes. The independent observer will be blinded to group allocation. The assessment battery (demographic data will be replaced by clinical data) will be repeated at the end of the intervention (approx. 11-12 weeks after surgery). The intervention-group will also have an addition of a telephone based semi structured interview regarding feasibility aspects and participation. Each week during the intervention participants will digitally answer one-item questions based on the included PROMs, (described in detail under "data collection").

Get Back pilot includes five core session and will be led by the PT-Get Back. The core session will be complemented by up to five shorter follow ups by telephone (booster sessions). The intervention in described more in detail under paragraph 8.

Outcome measurements are described in detail under paragraph 9. Treatment fidelity data including intervention dose, content, and adherence to intervention procedures will be collected.

Process and resource feasibility will be administrated by the variables: recruitment, session compliance, safety, and acceptability.

Feasibility data will be collected continuously during and at the end of the study period.

Data from accelerometer, patient reported outcome measures and physical capacity tests will be collected at baseline, and 11-12 weeks after surgery. Baseline variables such as age, gender, comorbidity, ASA-score, weight/height, smoking status, alcohol consumption, educational level, sick-leave status, pain duration (back and leg), and previous spine surgery will be collected from the patient. Preoperative cognitive function will be measured with the Cognitive Performance Scale. Pre- and postoperative clinical data such as type of surgery, complications, length of stay, analgesic use, discharge destination, re-operation, and re-admission to hospital will be collected from the medical records at each recruiting unit. For the standard physiotherapy group, pre- and postoperative physical therapy will also be collected as a control variable. Weekly measures will include one-item questions including steps per day, physical activity level, as well as variables related to pain catastrophizing, fear of movement, and self-efficacy. Weekly measures will be conducted digitally and take approximately 5 minutes to fill in.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Patients with malignancy, severe neurological -or rheumatic disease, idiopathic scoliosis, isthmic spondylolisthesis
* not able to understand written information and communicate in Swedish

Primary outcomes:
measure: Change in variables related to intervention content.
timeFrame: Once a week during the 12-week study period.
measure: The intervention participants frequency and length of contact with the study physiotherapist.
timeFrame: Continuously during the 12 week intervention.
measure: Checklist of included components at each treatment session.
timeFrame: Continuously during the 12 week intervention.
measure: Analysis of audio recordings from the intervention sessions.
timeFrame: Continuously during the 12 week intervention.
measure: Type and frequency of possible adverse events.
timeFrame: Continuously during the 12 week intervention.
measure: Percentage of patients eligible after the screening procedure.
timeFrame: Through study completion, an average of 6 month.
measure: Number of intervention sessions attended out of planned.
timeFrame: Through study completion for each intervention participant, an average of 12 weeks.
measure: Acceptability of data collection methods measured with a study specific questionnaire.
timeFrame: At the end of each participants 12 week study period.
measure: Participants experiences of the intervention collected via telephone interviews.
timeFrame: At the end of intervention/after 12 weeks.
Secondary outcomes:
measure: Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Physical function measured with the Timed-up-and-go test (TUG).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Postural balance measured with the One Leg Stand test.
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Functional leg strength measured with the 30 seconds sit-to-stand test.
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Self-reported physical activity collected with a two-item questionnaire from the National Board of Health and Welfare in Sweden.
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: The person's own goals regarding function collected with the Patient Specific Functional Scale (PSFS).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Health related quality of life collected with the EuroQol five dimension scale (EQ-5D 3L).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Self-reported disability collected with the Oswestry Disability Index (ODI).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Depressed mood collected with the depression subscale of the Hospital Anxiety and Depression Scale.
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Pain intensity level in the leg and back reported with the Numeric Rating Scale (NRS).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Catastrophizing thoughts related to pain collected with the Pain Catastrophizing Scale (PCS).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: Patient-reported kinesiophobia collected with the Swedish version of the Tampa Scale of Kinesiophobia (TSK-SV).
timeFrame: At baseline, and post-intervention/after 12 weeks
measure: General self-efficacy collected with the General Self-efficacy Scale (GSE).
timeFrame: At baseline, and post-intervention/after 12 weeks
Other outcomes:
Locations:
city: Västra Frölunda
country: Sweden
facility: Capio Spine Center Göteborg
state: Gothenburg
city: Stockholm
country: Sweden
facility: Ryggkirurgiskt centrum Stockholm
Study officials:
affiliation: Sophiahemmet Högskola
name: Mari K Lundberg
role: PRINCIPAL_INVESTIGATOR
References: