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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04591249
Other study ID # 201126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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