Telehealth Activity Intervention After Lumbar Spine Surgery (PASS)

Vanderbilt University Medical Center

Status: Completed

Conditions: Spinal Degenerative Disorder

Treatments: Behavioral: Physical activity intervention; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04968821

211126

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Physical Activity

Experimental group

Description:

Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.

Treatment:

Behavioral: Physical activity intervention

Usual Care

Other group

Description:

Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.

Treatment:

Other: Usual care