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出境医 / 临床实验 / Telehealth Activity Intervention After Lumbar Spine Surgery (PASS)

Telehealth Activity Intervention After Lumbar Spine Surgery (PASS)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Degenerative Disorder Behavioral: Physical activity intervention Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth Physical Activity Intervention After Lumbar Spine Surgery
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : July 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Physical Activity
Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.
Behavioral: Physical activity intervention
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
Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.
Other: Usual care
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.

Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults age 18 years or older
  2. Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
  3. English speaking

Exclusion Criteria:

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

Contacts
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Contact: Shannon Block 615-936-2438 shannon.s.block@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Shannon Block         
Principal Investigator: Kristin R Archer, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Academy of Orthopaedic Physical Therapy
Investigators
Layout table for investigator information
Principal Investigator: Kristin A Swygert, Ph.D. Vanderbilt University Medical Center
Tracking Information
First Submitted Date  ICMJE July 8, 2021
First Posted Date  ICMJE July 20, 2021
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE June 28, 2021
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telehealth Activity Intervention After Lumbar Spine Surgery
Official Title  ICMJE Telehealth Physical Activity Intervention After Lumbar Spine Surgery
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Degenerative Disorder
Intervention  ICMJE
  • Behavioral: Physical activity intervention
    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.
  • Other: Usual care
    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.
Study Arms  ICMJE
  • Experimental: Physical Activity
    Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.
    Intervention: Behavioral: Physical activity intervention
  • Usual Care
    Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.
    Intervention: Other: Usual care
Publications * Coronado RA, Master H, White DK, Pennings JS, Bird ML, Devin CJ, Buchowski MS, Mathis SL, McGirt MJ, Cheng JS, Aaronson OS, Wegener ST, Archer KR. Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery. BMC Musculoskelet Disord. 2020 Nov 27;21(1):783. doi: 10.1186/s12891-020-03816-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults age 18 years or older
  2. Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
  3. English speaking

Exclusion Criteria:

  1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
  2. Patients having surgery for spinal deformity as the primary indication
  3. Patients having revision surgery
  4. Patients having surgery for pseudarthrosis, trauma, infection, or tumor
  5. Presence of back and/or lower extremity pain < 3 months
  6. History of neurological disorder, resulting in moderate to severe movement dysfunction
  7. History of prior lumbar spine surgery
  8. Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon Block 615-936-2438 shannon.s.block@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04968821
Other Study ID Numbers  ICMJE 211126
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kristin Archer, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Academy of Orthopaedic Physical Therapy
Investigators  ICMJE
Principal Investigator: Kristin A Swygert, Ph.D. Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP