Telehealth Activity Intervention After Lumbar Spine Surgery (PASS)

Telehealth Physical Activity Intervention After Lumbar Spine Surgery

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 Overview

• Status: Completed
• Conditions: Spinal Degenerative Disorder
• Intervention / Treatment: Behavioral: Physical activity intervention; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity; Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.	Behavioral: Physical activity intervention; 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.
Other: Usual Care; Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.	Other: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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.	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.	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.	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.	Baseline to 12 months post-surgery

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Academy of Orthopaedic Physical Therapy
• Investigators: Principal Investigator: Kristin Archer, Ph.D., Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 211126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No