Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS)

Vanderbilt University Medical Center

Status: Completed

Conditions: Spinal Stenosis; Spondylosis; Spinal Degenerative Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04591249

201126 (Other Identifier)

Details and patient eligibility

About

There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery. The overall objective of this study is to conduct a two-group randomized control trial (RCT) to examine the feasibility and acceptability of a physical activity telehealth intervention delivered by a physical therapist for improving disability, physical function, pain, and physical activity compared to usual care after spine surgery for a degenerative lumbar condition. The physical activity intervention will include wearable technology and remote physical therapist support to counsel patients on a realistic progression of physical activity (steps per day). The central hypothesis is that this 8-week physical activity intervention performed at two weeks after surgery will be feasible and acceptable. The results of our randomized trial will be used to support a large multi-site clinical trial to test the effectiveness and implementation of this intervention

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults age 18 years or older, of both sexes and all races
2. Scheduled for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e., fusion) procedures.
3. Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.

Exclusion criteria

1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy will be excluded because individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration.
2. Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
3. Prior history of lumbar spine surgery
4. Presence of back and/or lower extremity pain < 3 month
5. History of neurological disorder, resulting in moderate to severe movement dysfunction
6. Unable to provide stable address and access to a telephone 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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16 participants in 2 patient groups

Usual postoperative care

Other group

Description:

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

Treatment:

Other: Usual care

Usual postoperative care + Physical activity intervention

Experimental group

Description:

Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.

Treatment:

Other: Usual care

Behavioral: Physical activity intervention