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Completed

NCT Number: NCT04591249

Physical Activity Intervention for Patients Following Lumbar Spine Surgery

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

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Key information

Conditions

Spinal Degenerative Disorder Behavior Bone Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18 years or older, of both sexes and all races
  • 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.
  • Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.

Exclusion criteria

  • 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.
  • Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
  • Prior history of lumbar spine surgery
  • Presence of back and/or lower extremity pain < 3 month
  • History of neurological disorder, resulting in moderate to severe movement dysfunction
  • Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.

Treatment and study plan

physical activity intervention

Behavioral

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.

Usual Care

Other

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.

Primary outcomes

  1. Recruitment rate

    Time frame: At 2 weeks after spine surgery

    Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.

  2. Adherence rate to study protocol at 3 months after spine surgery

    Time frame: From 2 weeks to 3-months after spine surgery

    Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.

  3. Adherence rate to study protocol at 6 months after spine surgery

    Time frame: From 2 weeks to 6-months after spine surgery

    Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.

  4. Adherence to physical activity intervention

    Time frame: From 2-weeks to 3-months after spine surgery

    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

  5. Number of adverse events

    Time frame: From 2-weeks to 3-months after spine surgery

    During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    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.

  2. PROMIS Physical Function

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    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.

  3. Numeric rating scale for back pain

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    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.

  4. Numeric rating scale for leg pain

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    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.

  5. Intensity of physical activity

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify time spent in different intensities of physical activity per day.

  6. Physical activity volume

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    A research-grade triaxial accelerometer (Actigraph GT3x) will be used to quantify total number of steps per day.

  7. Depressive symptoms

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    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.

  8. Fear of movement

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    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.

Other outcomes

  1. Opioid Use

    Time frame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

    A single-item Patient-reported opioid use questionnaire (yes vs. no).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Acronym: PASS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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