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

Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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.

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
Other: Usual postoperative care; Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.	Other: Usual care; Participants will receive postoperative care as determined by their treating surgeon. This includes 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.
Experimental: Usual postoperative care + Physical activity intervention; Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.	Other: Usual care; Participants will receive postoperative care as determined by their treating surgeon. This includes 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.; Behavioral: Physical activity intervention; Participants will 1) receive Fitbit, 2) be enrolled in a secure electronic platform to access Fitbit data, 3) receive 8-week remote counseling by a physical therapist that will include motivational interviewing and creating SMART goals (1 session per week) through a web-based teleconference platform, and 4) receive usual postoperative care directed by their surgeon. The first session will be 45 minutes and sessions 2-8 will be 30 minutes each. During the sessions, participant's confidence in meeting daily step goals will be assessed using a 0-10 scale. If self-reported confidence to meet their goal is <8, the physical therapist will help participants modify their goal using techniques such as problem-solving, positive statements and affirmations. Progression will be made only if daily steps goals are met for at least 4 out of 7 days a week. If this weekly step goal is not met, a physical therapist will help the participant identify solutions for realistic progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.	At 2 weeks after spine surgery
Adherence rate to study protocol at 3 months after spine surgery	Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.	From 2 weeks to 3-months after spine surgery
Adherence rate to study protocol at 6 months after spine surgery	Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.	From 2 weeks to 6-months after spine surgery
Adherence to physical activity intervention	Number of weekly step goals completed by participant, which will be examined via Fitabase. In addition, number of weekly Zoom calls completed with the physical therapist will be recorded	From 2-weeks to 3-months after spine surgery
Number of adverse events	During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.	From 2-weeks to 3-months after spine surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	A 10-item questionnaire will be used to measure condition-specific disability that assesses the impact of lumbar spinal disorders on activities of daily living. Each item is measured from 0 to 5, representing low and high disability, respectively. Total score ranges from 0 to 50.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
PROMIS Physical Function	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.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Numeric rating scale for back pain	Numeric rating scale will be used to assess the pain intensity using the single-item for back, which is scored from 0 to 10, representing no pain and the worst pain, respectively.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Numeric rating scale for leg pain	Numeric rating scale will be used to assess the pain intensity using the single-item for leg, which is scored from 0 to 10, representing no pain and the worst pain, respectively.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Intensity of physical activity	A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify time spent in different intensities of physical activity per day.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Physical activity volume	A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Depressive symptoms	PROMIS Depression 4 item short form will be used to measure depressive symtpoms. Each item is measured from 1 to 5, representing low to high depressive symptoms. Total score ranges from 4 to 20.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Fear of movement	A 13-item Tampa Scale for 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 13 to 52 with higher scores indicating greater fear of movement.	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	A single-item Patient-reported opioid use questionnaire (yes vs. no).	Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Study Director: Kristin R Archer, DPT, PhD, Vanderbilt University Medical Center

Publications and helpful links

Helpful Links

• Website that provides brief description of the PASS trial

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): September 24, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; pain; disability; wearable technology; behavioral model; funciton
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Spondylosis
• Other Study ID Numbers: 201126 (GSK eTrack)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Given the pilot nature of the trial, the IPD will not be available to other researchers.

Drug and device information, study documents

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