Spinal Degenerative DisorderPASSNCT04968821
Telehealth Activity Intervention After Lumbar Spine Surgery
A study testing Physical activity intervention in people with Spinal Degenerative Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Degenerative Disorder
- What is being tested?
- Physical activity intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older
- Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
- English speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Telehealth Physical 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.
- Conditions
- Spinal Degenerative Disorder
- Being tested
- Physical activity intervention, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
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 careOther
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 group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention. Receives: Behavioral: Physical activity intervention |
| Usual Care | Other | Participants randomized to usual care will receive postoperative care as determined by their treating surgeon. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily post-operative physical activity as measured by an accelerometer.
Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer
Measured: Baseline to 12 months post-surgery
Secondary outcomes (9)
Post-operative physical activity as measured by an accelerometer.
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
Measured: Baseline to 12 months post-surgery
Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain
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.
Measured: Baseline to 12 months post-surgery
Disability as measured by the Oswestry Disability Index.
The ODI has 10 items and scores range from 0 to 100%. A higher score represents higher disability.
Measured: Baseline to 12 months post-surgery
Back pain as measured by the Numeric Rating Scale (NRS).
The NRS has 1 item and scores range from 0 to 10. A higher score represents more back pain.
Measured: Baseline to 12 months post-surgery
Leg pain as measured by the Numeric Rating Scale (NRS).
The NRS has 1 item and scores range from 0 to 10. A higher score represents more leg pain.
Measured: Baseline to 12 months post-surgery
Opioid Use as measured by patient self-report.
A single-item patient-reported opioid use question that ask about current opioid use.
Measured: Baseline to 12 months post-surgery
Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain
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.
Measured: Baseline to 12 months post-surgery
Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ)
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.
Measured: Baseline to 12 months post-surgery
Fear of movement as measured by theTampa Scale of Kinesiophobia.
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.
Measured: Baseline to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start28 Jun 2021
- Primary completion1 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Degenerative DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Orthopaedic Physical Therapy
- Responsible party
- Principal investigator, Kristin Archer, Vanderbilt University Medical Center
- Investigators
- Kristin Archer, Ph.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968821
- Sponsor's protocol ID
- 211126
- Acronym
- PASS
- Status last verified
- May 2024
- First submitted
- 8 Jul 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33246446
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Physical Activity Intervention After Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT04968821
- Acronym / sponsor ID
- PASS / 211126
- Conditions
- Spinal Degenerative Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Academy of Orthopaedic Physical Therapy
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical activity interventionParticipants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention. |
| Usual Care | Other | Other: Usual careParticipants randomized to usual care will receive postoperative care as determined by their treating surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 years or older
- Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
- English speaking
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionParticipants 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. | Behavioural | Physical Activity |
| Usual careUsual 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. | Other | Usual Care |
Primary outcome
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
9 secondary outcomes
Post-operative physical activity as measured by an accelerometer.
Time frame: Baseline to 12 months post-surgery
Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain
Time frame: Baseline to 12 months post-surgery
Disability as measured by the Oswestry Disability Index.
Time frame: Baseline to 12 months post-surgery
Back pain as measured by the Numeric Rating Scale (NRS).
Time frame: Baseline to 12 months post-surgery
Leg pain as measured by the Numeric Rating Scale (NRS).
Time frame: Baseline to 12 months post-surgery
Opioid Use as measured by patient self-report.
Time frame: Baseline to 12 months post-surgery
Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain
Time frame: Baseline to 12 months post-surgery
Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline to 12 months post-surgery
Fear of movement as measured by theTampa Scale of Kinesiophobia.
Time frame: Baseline to 12 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 33246446Coronado 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Degenerative Disorder
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Archer, Ph.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Spinal Degenerative Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily post-operative physical activity as measured by an accelerometer. (time frame: Baseline to 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.