Telehealth Activity Intervention After Lumbar Spine Surgery (PASS)

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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

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

Trial contacts and locations

1

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Central trial contact

Amanda Priest

Data sourced from clinicaltrials.gov

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