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Completed

NCT Number: NCT04968821

Telehealth Activity Intervention After Lumbar Spine Surgery

The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery.

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Key information

Conditions

Spinal Degenerative Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, 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
  • Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
  • English speaking

Exclusion criteria

  • Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
  • Patients having surgery for spinal deformity as the primary indication
  • Patients having revision surgery
  • Patients having surgery for pseudarthrosis, trauma, infection, or tumor
  • Presence of back and/or lower extremity pain < 3 months
  • History of neurological disorder, resulting in moderate to severe movement dysfunction
  • Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention

Treatment and study plan

physical activity intervention

Behavioral

Participants randomized to the physical activity intervention will receive a Fitbit and be enrolled in Fitabase (Fitbit tracking system). Participants will also participate in 8 tele-health sessions with a physical therapist. Sessions will involve setting weekly physical activity goals and reviewing the participant's physical activity on the Fitbit tracking system.

Usual Care

Other

Usual postoperative care includes surgeon-directed 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. Mean daily post-operative physical activity as measured by an accelerometer.

    Time frame: Baseline to 12 months post-surgery

    Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer

Secondary outcomes

  1. Post-operative physical activity as measured by an accelerometer.

    Time frame: Baseline to 12 months post-surgery

    Post-operative physical activity will be calculated as the time spent in different intensities of physical activity over a period of 7 days as measured by accelerometer

  2. Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain

    Time frame: Baseline to 12 months post-surgery

    The 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. Total raw scores will be converted to T-scores.

  3. Disability as measured by the Oswestry Disability Index.

    Time frame: Baseline to 12 months post-surgery

    The ODI has 10 items and scores range from 0 to 100%. A higher score represents higher disability.

  4. Back pain as measured by the Numeric Rating Scale (NRS).

    Time frame: Baseline to 12 months post-surgery

    The NRS has 1 item and scores range from 0 to 10. A higher score represents more back pain.

  5. Leg pain as measured by the Numeric Rating Scale (NRS).

    Time frame: Baseline to 12 months post-surgery

    The NRS has 1 item and scores range from 0 to 10. A higher score represents more leg pain.

  6. Opioid Use as measured by patient self-report.

    Time frame: Baseline to 12 months post-surgery

    A single-item patient-reported opioid use question that ask about current opioid use.

  7. Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain

    Time frame: Baseline to 12 months post-surgery

    Depression 4-item short form will be used to measure depression. Responses for each item vary from Never, Rarely, Sometimes, Often, and Always. The lowest score is 4 and the highest score is 20, with higher scores indicating greater severity of depression.Total raw scores will be converted to T-scores.

  8. Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: Baseline to 12 months post-surgery

    PSEQ has 10 items and responses vary from Not at all confident to completely confident. The lowest score is 0 and the highest score is 60 with a higher score representing higher pain self-efficacy.

  9. Fear of movement as measured by theTampa Scale of Kinesiophobia.

    Time frame: Baseline to 12 months post-surgery

    The 17-item Tampa Scale of 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 17 to 68 with higher scores indicating greater fear of movement.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Academy of Orthopaedic Physical Therapy

Registry information

Official study title

Telehealth Physical Activity Intervention After Lumbar Spine Surgery

Acronym: PASS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2021
Registry last updated
May 29, 2024

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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