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

Spinal Stenosis Lumbar Clinical Trial

— GetBack  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806593
• Other study ID #: Get Back
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Sophiahemmet University
• Contact: Mari K Lundberg
• Phone: +46 8-406 20 91
• Email: mari.lundberg[@]shh.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Behavioral:
• Get Back pilot
A health-promoting program, targeting physical activity behavior, with a person-centred approach led by a physiotherapist digitally during 12 weeks.

Locations

Country	Name	City	State
Sweden	Ryggkirurgiskt centrum Stockholm	Stockholm
Sweden	Capio Spine Center Göteborg	Västra Frölunda	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Sophiahemmet University	AFA Insurance, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in variables related to intervention content.	A questionnaire including 14 one-item questions aiming to capture steps per day (reported from a pedometer), self-reported physical activity level, and relevant aspects of pain catastrophizing, fear of movement and self-efficacy (on rating scales ranging from 0 to 10).	Once a week during the 12-week study period.
Primary	The intervention participants frequency and length of contact with the study physiotherapist.	The data will be noted by the study physiotherapist on each session protocol.	Continuously during the 12 week intervention.
Primary	Checklist of included components at each treatment session.	The treatment components addressed during each intervention session will be noted by the study physiotherapist on a checklist.	Continuously during the 12 week intervention.
Primary	Analysis of audio recordings from the intervention sessions.	Audio recordings of the intervention sessions will be conducted and transcribed for post-hoc analysis by a third party (trained in person centredness and cognitive behavioural therapy) to ensure that the key components of the intervention are included.	Continuously during the 12 week intervention.
Primary	Type and frequency of possible adverse events.	The type and frequency of possible adverse events during the intervention will be collected by the study physiotherapist and noted on each session protocol.	Continuously during the 12 week intervention.
Primary	Percentage of patients eligible after the screening procedure.	The data will be noted on screeninglists.	Through study completion, an average of 6 month.
Primary	Number of intervention sessions attended out of planned.	The data will be noted by the study physiotherapist on each session protocol.	Through study completion for each intervention participant, an average of 12 weeks.
Primary	Acceptability of data collection methods measured with a study specific questionnaire.	Study specific questionnaires including questions related to experiences from participants and assessors of the methods used for data collection.	At the end of each participants 12 week study period.
Primary	Participants experiences of the intervention collected via telephone interviews.	Semi structured telephone interviews with participants of the intervention group, which will be audio recorded and transcribed into text material.	At the end of intervention/after 12 weeks.
Secondary	Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).	Reported as number of steps per day.	At baseline, and post-intervention/after 12 weeks
Secondary	Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).	Reported as time spent in light physical activity, moderate to vigorous physical activity (MVPA) and time spent sedentary.	At baseline, and post-intervention/after 12 weeks
Secondary	Physical function measured with the Timed-up-and-go test (TUG).	The time it takes for a participant to rise from a chair, walk 3 meters, turn, walk back to the chair and sit down. Reported in seconds.	At baseline, and post-intervention/after 12 weeks
Secondary	Postural balance measured with the One Leg Stand test.	The time a participant can stand on one leg, reported in seconds.	At baseline, and post-intervention/after 12 weeks
Secondary	Functional leg strength measured with the 30 seconds sit-to-stand test.	Reported as the number of chair rises a participant can complete during 30 seconds.	At baseline, and post-intervention/after 12 weeks
Secondary	Self-reported physical activity collected with a two-item questionnaire from the National Board of Health and Welfare in Sweden.	The results are presented as reaching or not reaching 150 minutes of moderate physical activity per week.	At baseline, and post-intervention/after 12 weeks
Secondary	The person's own goals regarding function collected with the Patient Specific Functional Scale (PSFS).	The participant will choose three activities of individual importance and rate the ability to perform each activity on a scale from 0 (not able to perform the activity) to 10 (can perform the activity unhindered).	At baseline, and post-intervention/after 12 weeks
Secondary	Health related quality of life collected with the EuroQol five dimension scale (EQ-5D 3L).	Reported as an index utility score between 0 to 1 (a higher score indicates better health state) and a visual analogue scale of self-related overall health ranging from 0 to 100 (a higher score indicates better overall health).	At baseline, and post-intervention/after 12 weeks
Secondary	Self-reported disability collected with the Oswestry Disability Index (ODI).	Score range from 0 to 50. Higher scores represent greater disability.	At baseline, and post-intervention/after 12 weeks
Secondary	Depressed mood collected with the depression subscale of the Hospital Anxiety and Depression Scale.	Score range from 0 to 21. A score of 8 or more indicated depression.	At baseline, and post-intervention/after 12 weeks
Secondary	Pain intensity level in the leg and back reported with the Numeric Rating Scale (NRS).	On a scale from 0 to 10, where a higher reported number means higher pain intensity.	At baseline, and post-intervention/after 12 weeks
Secondary	Catastrophizing thoughts related to pain collected with the Pain Catastrophizing Scale (PCS).	Score range from 0 to 52. Higher scores mean higher degree of catastrophizing thoughts related to pain.	At baseline, and post-intervention/after 12 weeks
Secondary	Patient-reported kinesiophobia collected with the Swedish version of the Tampa Scale of Kinesiophobia (TSK-SV).	Score range from 17 to 68. Higher scores mean higher degree of fear of movement.	At baseline, and post-intervention/after 12 weeks
Secondary	General self-efficacy collected with the General Self-efficacy Scale (GSE).	Score range from 10 to 40. Higher scores mean higher self-efficacy.	At baseline, and post-intervention/after 12 weeks