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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| Göteborg University | OTHER |
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This study aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). LSS is common, especially among older adults, leading to increased health risks and reduced quality of life. Despite its prevalence (about 60% of all spinal surgeries in Sweden), many LSS patients remain physically inactive post-surgery, worsening their health. Rehabilitation remains a global challenge with unequal access, and many patients feel disengaged from the process. Get Back is a digital rehabilitation program including three components: gradually increasing physical activity, managing fear and avoidance behaviors, and using behavior change techniques. It has shown promising results in a pilot study, increasing daily steps. The program uses a person-centered approach tailored to personal needs. This multicenter randomized controlled trial will assess efficacy, process, and cost-effectiveness. It will also explore how preoperative values such as physical capacity and psychological factors predict changes in daily steps after surgery. Data will be collected via questionnaires, functional tests, and interviews, with the primary outcome being daily steps measured with motion sensors. The study will involve 252 patients from four spinal clinics. Get Back promotes increased physical activity and accessible rehabilitation, contributing to better health for LSS patients.
The Get Back rehabilitation program has been developed using the Medical Research Councils (MRC) framework. A feasibility study (NCT05806593) has been completed involving 29 patients (mean age 67) who underwent surgery for LSS. The Get Back intervention (completely digital i.e. assessments and rehabilitation) was shown to be feasible and resulted in clinically significant improvements in daily steps at 12 weeks' post-surgery.
To evaluate the effectiveness and process of Get Back a multicenter randomized controlled trial including three sub-studies will be conducted. The specific research questions we aim to investigate in this RCT are:
Patients will be recruited from four clinical study sites (two private spine clinics and two hospitals). All patients undergo a clinical examination by an orthopedic surgeon as part of standard preoperative care. If a surgical decision is made and the patient is placed on the waiting list, a local recruiter at each site will hand out written study information to the patients meeting inclusion criteria and ask if a physical therapist from the study can make contact to provide further 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.
At baseline (approx. 2 weeks pre-surgery), participants meet with an assessor (physical therapist) via a digital care platform for collection of demographic data, personal goals, and to conduct physical capacity tests. Questionnaires are sent out through a digital application and patients wear an accelerometer for 7 days sent out by mail. Outcome variables are described more in detail under the heading Outcome Measures in the trial registration. The follow-ups are scheduled at 6 weeks, 3 months, 6 months, and 1-year post-surgery. Accelerometry and questionnaires will be collected at each follow-up, whereas physical capacity tests will be conducted at 3 and 12 months post-surgery. Clinical data such as type of surgery, complications, discharge destination will be collected from the patients' medical records at 3 months post-surgery.
After baseline assessments, patients are randomly assigned (1:1) to either control or intervention group. The randomization will be based on a computerized random list converted to concealed envelopes. The assessor will be blinded to group allocation.
Participants in the intervention group (Get Back, n=126) will have one pre-surgery video session with a physical therapist, followed by up to five core video sessions and five booster telephone sessions over 13 weeks. Session frequency is decided collaboratively, based on person-centered care. The intervention includes three components: graded physical activity, addressing fear avoidance beliefs, and promoting behavior change. A person-centered health plan is created at the first session, based on the patient's story and baseline assessment. The plan includes personalized activity goals, monitored using a weekly physical activity diary to track steps, barriers, and progress. A sub-sample of the intervention group, approximately 15-20 participants, will be interviewed regarding their experiences of the intervention and intervention content at 3 months post-surgery using a semi-structured interview guide.
Participants in the control group (n=126) will follow standard rehabilitation (physical therapy as provided at each site). Data on the frequency and content of rehabilitating sessions during the study will be collected as a control variable at each follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Get Back) | Experimental | The intervention includes up to 5 core sessions (video call) and 5 booster sessions (telephone) over 13 weeks (approx. 1 week before until 12 weeks after surgery). All sessions will be led by a physical therapist. The focus of each core session (1-5) is as follows:
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| Control (standard physical therapy) | No Intervention | 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 from the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Get Back | Behavioral | A rehabilitation program, targeting physical activity behavior, with a person-centered approach led by a physical therapist during 12 weeks (1 week before surgery until 12 weeks after surgery) in a digital format. |
| Measure | Description | Time Frame |
|---|---|---|
| Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+). | Reported as number of steps per day. The primary endpoint is 3 months postoperatively. | At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Direct costs, indirect costs and productivity losses collected with a self-report questionnaire. | Data for the health economic evaluation. A questionnaire including 10 questions (as well as subsections) aiming to capture costs from a societal perspective including direct costs (consultations, medical use, hospital stays), indirect (transportation), and productivity losses (sick leave) based on participants self-report. Treatment adherence and trial treatment costs, including education, the digital platform, and intervention materials, will be collected by the study physical therapist. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mari K Lundberg | Contact | +46 8-406 20 91 | mari.lundberg@shh.se |
| Name | Affiliation | Role |
|---|---|---|
| Mari K Lundberg | Sophiahemmet University/Sophiahemmet Högskola | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryggkirurgiskt centrum Stockholm | Recruiting | Stockholm | 11433 | Sweden | ||
| Södersjukhuset |
The data in the study will be pseudonymized (coded) personal data, and Swedish legislation prohibits us from sharing this completely open. Some data is available upon request, which will be handled according to the relevant legislation.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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 preoperative baseline, 3 and 12 months postoperative follow-up. |
| Postural balance measured with the One Leg Stand test. | The time a participant can stand on one leg, reported in seconds. | At preoperative baseline, 3 and 12 months postoperative follow-up. |
| 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 preoperative baseline, 3 and 12 months postoperative follow-up. |
| 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 preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up. |
| Self-reported back-related disability collected with the Oswestry Disability Index (ODI). | Score range from 0 to 50. Higher scores represent greater disability. | At preoperative baseline, 3 and 12 months postoperative follow-up. |
| 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 preoperative baseline, 3 and 12 months postoperative follow-up. |
| 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 preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up |
| 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 preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up. |
| 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 indicates depression. | At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up. |
| Pain self-efficacy collected with the 2-item Pain Self-Efficacy Questionnaire (PSEQ-2). | The questions are rated on a scale from 0 (not at all confident) to 6 (completely confident). A score of 5 or less indicates that the person might be in need of help with their confidence in functioning in the presence of their pain. A score of 8 or higher reflects a desirable level of pain self-efficacy or confidence in functioning in the presence of pain. | At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up. |
| At 6 weeks, 3, 6 and 12 months postoperative follow-up. |
| Health related quality of life collected with the EuroQol five dimension scale (EQ-5D 3L) | Data for the health economic evaluation. 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 preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up. |
| Participants experiences of the intervention content collected via telephone interviews. | Semi structured telephone interviews with participants from the intervention group, which will be audio recorded and transcribed into text material. | At 3 month postoperative follow-up (post-intervention). |
| Patient perceptions of person-centered care rated with the Generic Person-Centered Care Questionnaire (GPCCQ). | The questionnaire involves 18 questions answered on a 5-point scale where 1 ="No, not at all", and 5="Yes, completely". A higher scores mean a higher perception of person-centered care being present in the care. | At 3 months postoperative follow-up. |
| Recruiting |
| Stockholm |
| 11861 |
| Sweden |
| Akademiska sjukhuset | Recruiting | Uppsala | 75185 | Sweden |
| Capio Spine Center Göteborg | Recruiting | Västra Frölunda | 42130 | Sweden |