Clinical trial NCT04968821: Telehealth Activity Intervention After Lumbar Spine Surgery
Official title: Telehealth Physical Activity Intervention After Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Degenerative Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Academy of Orthopaedic Physical Therapy
First posted: 2021-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Adults age 18 years or older
2. Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
3. English speaking

Exclusion Criteria:

1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
2. Patients having surgery for spinal deformity as the primary indication
3. Patients having revision surgery
4. Patients having surgery for pseudarthrosis, trauma, infection, or tumor
5. Presence of back and/or lower extremity pain \< 3 months
6. History of neurological disorder, resulting in moderate to severe movement dysfunction
7. Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention

Primary outcomes:
measure: Mean daily post-operative physical activity as measured by an accelerometer.
timeFrame: Baseline to 12 months post-surgery
Secondary outcomes:
measure: Post-operative physical activity as measured by an accelerometer.
timeFrame: Baseline to 12 months post-surgery
measure: Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain
timeFrame: Baseline to 12 months post-surgery
measure: Disability as measured by the Oswestry Disability Index.
timeFrame: Baseline to 12 months post-surgery
measure: Back pain as measured by the Numeric Rating Scale (NRS).
timeFrame: Baseline to 12 months post-surgery
measure: Leg pain as measured by the Numeric Rating Scale (NRS).
timeFrame: Baseline to 12 months post-surgery
measure: Opioid Use as measured by patient self-report.
timeFrame: Baseline to 12 months post-surgery
measure: Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain
timeFrame: Baseline to 12 months post-surgery
measure: Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline to 12 months post-surgery
measure: Fear of movement as measured by theTampa Scale of Kinesiophobia.
timeFrame: Baseline to 12 months post-surgery
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristin Archer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coronado RA, Master H, White DK, Pennings JS, Bird ML, Devin CJ, Buchowski MS, Mathis SL, McGirt MJ, Cheng JS, Aaronson OS, Wegener ST, Archer KR. Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery. BMC Musculoskelet Disord. 2020 Nov 27;21(1):783. doi: 10.1186/s12891-020-03816-y.