Your session is about to expire
← Back to Search
Telehealth Physical Activity Intervention for Spinal Degeneration (PASS Trial)
N/A
Waitlist Available
Led By Kristin A Swygert, Ph.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months post-surgery
Awards & highlights
PASS Trial Summary
This trial is testing whether a postoperative physical activity intervention that uses wearable technology and remote physical therapist support helps patients recover better than usual care after lumbar spine surgery.
Who is the study for?
This trial is for adults over 18 who are scheduled for a first-time lumbar spine surgery to treat spinal degeneration. They must speak English and have internet access with a smart device or computer. It's not for those having revision surgery, pain less than 3 months, microsurgical techniques only, surgeries due to trauma, infection, tumor or pseudarthrosis, spinal deformity as primary issue, or severe neurological disorders.Check my eligibility
What is being tested?
The study tests if a telehealth physical activity program helps patients recover better after lumbar spine surgery compared to usual care. Half the participants will get wearable tech and remote support from physical therapists over eight sessions; the other half will receive standard postoperative care.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like exercise guidance rather than medication or invasive procedures, side effects may include typical risks associated with physical activity such as muscle soreness or strain.
PASS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for back surgery to treat a degenerative condition.
PASS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean daily post-operative physical activity as measured by an accelerometer.
Secondary outcome measures
Back pain as measured by the Numeric Rating Scale (NRS).
Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain
Disability as measured by the Oswestry Disability Index.
+6 morePASS Trial Design
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.
Group II: Physical ActivityExperimental Treatment1 Intervention
Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical activity intervention
2009
N/A
~2960
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,132 Total Patients Enrolled
Academy of Orthopaedic Physical TherapyUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Kristin A Swygert, Ph.D.Principal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had a revision surgery.I am having surgery primarily to correct a spinal deformity.I have a neurological disorder that severely affects my movement.I am 18 years old or older.I am having surgery for a false joint, injury, infection, or tumor.I have had back or leg pain for less than 3 months.I am scheduled for back surgery to treat a degenerative condition.I am having or have had a minor spine surgery using microsurgical techniques.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Activity
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots left for volunteers?
"The information available on clinicaltrials.gov leads us to believe that this clinical trial is still looking for patients. This study was originally posted on 6/28/2021, with the most recent update being on 2/10/2022. They are hoping to enroll 60 patients at a single location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger