Telehealth Activity Intervention After Lumbar Spine Surgery
- Conditions
- Spinal Degenerative Disorder
- Interventions
- Other: Usual careBehavioral: Physical activity intervention
- Registration Number
- NCT04968821
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Adults age 18 years or older
- Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
- English speaking
- Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
- Patients having surgery for spinal deformity as the primary indication
- Patients having revision surgery
- Patients having surgery for pseudarthrosis, trauma, infection, or tumor
- Presence of back and/or lower extremity pain < 3 months
- History of neurological disorder, resulting in moderate to severe movement dysfunction
- Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual care Participants randomized to usual care will receive postoperative care as determined by their treating surgeon. Physical Activity Physical activity intervention Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.
- Primary Outcome Measures
Name Time Method Mean daily post-operative physical activity as measured by an accelerometer. Baseline to 12 months post-surgery Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer
- Secondary Outcome Measures
Name Time Method Leg pain as measured by the Numeric Rating Scale (NRS). Baseline to 12 months post-surgery The NRS has 1 item and scores range from 0 to 10. A higher score represents more leg pain.
Post-operative physical activity as measured by an accelerometer. Baseline to 12 months post-surgery Post-operative physical activity will be calculated as the time spent in different intensities of physical activity over a period of 7 days as measured by accelerometer
Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain Baseline to 12 months post-surgery The PROMIS Physical Function 4-item short form will be used to measure physical function. Each item is measured from 1 to 5, representing low to high physical function, respectively. Total score ranges from 4 to 20. Total raw scores will be converted to T-scores.
Back pain as measured by the Numeric Rating Scale (NRS). Baseline to 12 months post-surgery The NRS has 1 item and scores range from 0 to 10. A higher score represents more back pain.
Disability as measured by the Oswestry Disability Index. Baseline to 12 months post-surgery The ODI has 10 items and scores range from 0 to 100%. A higher score represents higher disability.
Opioid Use as measured by patient self-report. Baseline to 12 months post-surgery A single-item patient-reported opioid use question that ask about current opioid use.
Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain Baseline to 12 months post-surgery Depression 4-item short form will be used to measure depression. Responses for each item vary from Never, Rarely, Sometimes, Often, and Always. The lowest score is 4 and the highest score is 20, with higher scores indicating greater severity of depression.Total raw scores will be converted to T-scores.
Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ) Baseline to 12 months post-surgery PSEQ has 10 items and responses vary from Not at all confident to completely confident. The lowest score is 0 and the highest score is 60 with a higher score representing higher pain self-efficacy.
Fear of movement as measured by theTampa Scale of Kinesiophobia. Baseline to 12 months post-surgery The 17-item Tampa Scale of Kinesiophobia will be used to measure fear of movement. It has two sub-scales (activity avoidance and fear of pain) and the total score ranges from 17 to 68 with higher scores indicating greater fear of movement.
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States