Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Conditions
Keywords
Physical Activity, lumbar spinal stenosis (LSS), spinal stenosis decompression surgery, Musculoskeletal Diseases, Motivational Interviewing
Brief summary
Back pain can be disabling, limiting the ability to walk and to engage in physical activity. For patients with degenerative lumbar spinal stenosis, decompressive surgery often provides substantial pain relief and improved mobility. However, research has shown that even after successful surgery, most patients do not increase physical activity or walking. This is important because regular physical activity can help older adults prevent and manage chronic disease, delay functional decline, and maintain independence. The goal of our study, called the Activity post Spinal Surgery Engagement Trial (ASSET), is to test whether a behavioral program can help patients become more physically active after spine surgery. The investigators have evaluated strategies to help people improve their physical activity after knee replacement surgery and would now like to understand whether these interventions are effective for patients undergoing spine surgery. The intervention combines two approaches designed to motivate behavior change. Motivational interviewing invokes internal motivation, where patients work with a trained coach to recognize the importance of walking habits, prepare for change, and develop and implement an effective walking plan. External motivation is based on financial incentives, where patients receive small but concrete rewards for obtaining their physical activity goals. The investigators want to test whether this intervention is better than simply providing patients with an activity tracker, so the study will randomly assign interested participants to one of two groups: the motivational interviewing and financial incentive intervention, or a control arm. All participants will receive a Fitbit activity monitor, and patients in the intervention group will also receive coaching sessions and financial incentives. This pilot study will help determine whether the program is acceptable to patients and whether it shows promise for improving physical activity after spine surgery.
Interventions
BEHAVIORALWrist based activity tracker wear
Activity tracking data will be collected on a weekly basis. Participants who receive this intervention are eligible to receive $5 for every week they wear their wrist-based activity tracker \>10 hours for \>4/7 days a week, beginning 6-weeks after surgery from weeks 6-31 ($130 maximum total).
Basic study activities begin approximately two-weeks before LDS and end approximately 24-months after LDS. Basic study activities include: two in-person visits at the clinic site (2 weeks before LDS and 32-weeks after LDS), having check-in calls with study staff weekly from weeks 1-13 after surgery and every other week for weeks 14-31, completing 4 surveys, and wearing an ActiGraph activity tracker (waist-worn) for three one-week periods throughout the study (2-weeks before-LDS, 32-weeks post-LDS, and one-year post-LDS). All participants will be eligible to receive up to $155 for completing these activities over the course of one year.
As part of TAC(MI)+FI, participants speak with a health coach at Brigham and Women's Hospital once a week via telephone for weeks 6-13 following surgery, and once every other week for weeks 14-31 after surgery. Participants in this arm can receive financial rewards for achieving weekly step goals, as well as bonus rewards for achieving goals multiple weeks in a row. Over the course of this 6-month long TAC(MI)+FI intervention period, these participants are able to receive up to $380 for meeting step goals, and up to $110 in bonus rewards for sustaining step goals.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Two-arm parallel randomized control trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age: 40-85 years * Scheduled to undergo a decompressive lumbar laminectomy with or without concomitant lumbar fusion * LSS is principal diagnosis for lumbar decompression surgery * Passes the Physical Activity Readiness Questionnaire (PAR-Q) * Agrees to all study technology requirements * Able to wear the ActiGraph for ≥ 4/7 days for ≥ 10 hours per day during pre-screening * Average baseline steps/day \< 6,000 during pre-screening assessment period
Exclusion criteria
* Lives in a nursing home * Non-English speaking * Uses a wheelchair for all ambulation * Has a physical condition resulting in inability to walk or makes walking -unstable * Diagnosis of dementia, epilepsy, Parkinson's Disease, or peripheral neuropathy with documented gait or balance disturbance of falls related to the condition * Has psychological issues that preclude participation * Surgeon-documented other reason for study exclusion * Primary indication for surgery is not lumbar spinal stenosis (this could include primary or metastatic tumor, spine infection, or sagittal deformity issues) * Has an inpatient or musculoskeletal surgery scheduled within the 6 months following lumbar decompression surgery * Has a history of past spine surgery within one year of date of pre-screen * Has a history of more than one spine surgery in the zone of proposed surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Proportion of eligible participants who consent | Baseline | The proportion of eligible participants who consent to the study will be computed as the number of participants who consent divided by the number of participants eligible to participate. |
| Change in average daily step count | 2 weeks pre-LDS to 32 Weeks post-LDS | The primary efficacy outcome in this trial is the difference in average daily step count at end of intervention (Week 32) between the two treatment arms as measured by the ActiGraph activity monitor. |
| Feasibility: Retention rate | 52 Weeks post-LDS | Retention rate will be calculated as the number of participants completing the 12-month follow-up divided by the number of participants randomized. |
| Feasibility: Satisfaction | 52 Weeks post-LDS | Satisfaction with the study will be assessed on a 4 point Likert scale from 'very satisfied' to 'very dissatisfied'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weekly minutes of moderate-to-vigorous physical activity (MVPA) | 2 weeks pre-LDS to 32 Weeks post-LDS | Change in the number of minutes per week that subjects spent engaged in MVPA from 2-weeks pre-LDS to 32-weeks post-LDS as measured by ActiGraph |
| Change in Oswestry Disability Index (ODI) | 2 weeks pre-LDS to 52 Weeks post-LDS | Change in subjects' pain and functional status using the Oswestry Disability Index (ODI) at 19, 32, and 52-weeks post-LDS as measured by the questionnaire. The Oswestry Disability Index (ODI) is scored as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. |
| Change in 40-meter fast-paced walk test | 2 weeks pre-LDS to 32 Weeks post-LDS | Change in subjects' performance at 32 weeks post-LDS as measured by the 40-meter fast-paced walk test. The outcome of the 40-meter fast-paced walk test is the time in seconds required to complete the 40-meter distance. |
| Change in Mini-BESTest (Mini Balance Evaluation Systems Test) | 2 weeks pre-LDS to 32 Weeks post-LDS | Change in subjects' performance at 32 weeks post-LDS as measured by the Mini-BESTest (Mini Balance Evaluation Systems Test). Total score for the the Mini-BESTest range from 0 to 28. Higher scores indicate better balance performance. |
Countries
United States
Outcome results
None listed