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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Participants randomized to the physical activity intervention will receive a Fitbit and be enrolled in Fitabase (Fitbit tracking system). Participants will also participate in 8 tele-health sessions with a physical therapist. Sessions will involve setting weekly physical activity goals and reviewing the participant's physical activity on the Fitbit tracking system.
Usual postoperative care includes surgeon-directed lifting restrictions, advice to stay active, and oral analgesics as needed. Physical therapy referral will be at the discretion of the surgeon. However, physical therapy is not typically started until 12 weeks after surgery.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Mean daily post-operative physical activity as measured by an accelerometer.
Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer
Time frame: Baseline to 12 months post-surgery
Post-operative physical activity as measured by an accelerometer.
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
Time frame: Baseline to 12 months post-surgery
Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain
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.
Time frame: Baseline to 12 months post-surgery
Disability as measured by the Oswestry Disability Index.
The ODI has 10 items and scores range from 0 to 100%. A higher score represents higher disability.
Time frame: Baseline to 12 months post-surgery
Back pain as measured by the Numeric Rating Scale (NRS).
The NRS has 1 item and scores range from 0 to 10. A higher score represents more back pain.
Time frame: Baseline to 12 months post-surgery
Leg pain as measured by the Numeric Rating Scale (NRS).
The NRS has 1 item and scores range from 0 to 10. A higher score represents more leg pain.
Time frame: Baseline to 12 months post-surgery
Opioid Use as measured by patient self-report.
A single-item patient-reported opioid use question that ask about current opioid use.
Time frame: Baseline to 12 months post-surgery
Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain
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.
Time frame: Baseline to 12 months post-surgery
Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ)
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.
Time frame: Baseline to 12 months post-surgery
Fear of movement as measured by theTampa Scale of Kinesiophobia.
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.
Time frame: Baseline to 12 months post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.