Physical Activity Intervention for Patients Following Lumbar Spine Surgery

Spinal Stenosis Clinical Trial

— PASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591249
• Other study ID #: 201126
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 1, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Degenerative Disorder
• Spinal Stenosis
• Spondylosis

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Recruitment rate	Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.	At 2 weeks after spine surgery
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Website that provides brief description of the PASS trial