Spinal Surgery for Lumbar Spinal Stenosis (LSS)ASSETNCT07825480
Activity Post Spinal Surgery Engagement Trial
A study testing Wrist based activity tracker wear, Basic Study Activities and Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives in people with Spinal Surgery for Lumbar Spinal Stenosis (LSS), run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Spinal Surgery for Lumbar Spinal Stenosis (LSS)
- What is being tested?
- Wrist based activity tracker wear, Basic Study Activities and Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to 1 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02139
Jamie E Collins, PhD, (617) 278-0524, JCollins13@bwh.harvard.edu
About this study
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.
Read more
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.
- Being tested
- Wrist based activity tracker wear, Basic Study Activities, Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives
- Keywords
- Physical Activity, lumbar spinal stenosis (LSS), spinal stenosis decompression surgery, Musculoskeletal Diseases, Motivational Interviewing
- Medical subject headings
- Motor Activity, Spinal Stenosis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist based activity tracker wearBehavioural
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 ActivitiesOther
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.
Telephonic Active Coaching (Motivational Interviewing) + Financial IncentivesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wrist-based activity tracker | Experimental | Participants in this arm receive usual post-operative care, complete all basic study activities, and receive a wrist-based activity tracker intervention. Receives: Behavioral: Wrist based activity tracker wear; Other: Basic Study Activities |
| Wrist-based activity tracker + TAC(MI)+FI | Experimental | Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI. Receives: Behavioral: Wrist based activity tracker wear; Other: Basic Study Activities; Behavioral: Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Proportion of eligible participants who consent
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.
Measured: Baseline
Change in average daily step count
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.
Measured: 2 weeks pre-LDS to 32 Weeks post-LDS
Feasibility: Retention rate
Retention rate will be calculated as the number of participants completing the 12-month follow-up divided by the number of participants randomized.
Measured: 52 Weeks post-LDS
Feasibility: Satisfaction
Satisfaction with the study will be assessed on a 4 point Likert scale from 'very satisfied' to 'very dissatisfied'.
Measured: 52 Weeks post-LDS
Secondary outcomes (4)
Change in weekly minutes of moderate-to-vigorous physical activity (MVPA)
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
Measured: 2 weeks pre-LDS to 32 Weeks post-LDS
Change in Oswestry Disability Index (ODI)
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.
Measured: 2 weeks pre-LDS to 52 Weeks post-LDS
Change in 40-meter fast-paced walk test
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.
Measured: 2 weeks pre-LDS to 32 Weeks post-LDS
Change in Mini-BESTest (Mini Balance Evaluation Systems Test)
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.
Measured: 2 weeks pre-LDS to 32 Weeks post-LDS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start19 Oct 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Surgery for Lumbar Spinal Stenosis (LSS)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized control trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Collins, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825480
- Sponsor's protocol ID
- 2026P001446
- Acronym
- ASSET
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot data largely focused on feasibility and acceptability