Telehealth Activity Intervention After Lumbar Spine Surgery
- Conditions
- Spinal Degenerative Disorder
- 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
- 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
Vanderbilt University Medical Center🇺🇸Nashville, Tennessee, United States