Chronic Low-back PainNCT04648683
Postoperative Telehealth Mindfulness Intervention After Spine Surgery
A study testing Individual telehealth mindfulness and Group telehealth mindfulness in people with Chronic Low-back Pain and Postsurgical Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Low-back Pain, Postsurgical Pain, Opioid Use
- What is being tested?
- Individual telehealth mindfulness and Group telehealth mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2021to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults
- Between the ages of 18 and 90
- Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
- Scheduled for their first lumbar spine surgery
- Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
- Presence of back and/or lower extremity pain persisting for at least 3 months
- Access to stable internet.
- Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery
Who cannot join
- Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
- Having surgery for the primary indication of a spinal deformity
- Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis
- Diagnosis of Alzheimer's disease or another form of dementia
- Traumatic Brain Injury (greater than mild severity)
Show all 9Show fewer
- History of bipolar disorder or dissociative disorder
- Active substance use disorder (in past month)
- Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery.
This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.
Read the detailed description
We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth mindfulness-based intervention (MBI) for patients recovering from spine surgery. The procedures will be as follows:
- Recruit, consent and enroll up to 26 patients over a period of 8 months who are planning to have their first lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment will occur at a routine preoperative clinic visit or over the phone, with the spine surgeon's permission to approach the patient.
- Two weeks after enrolled patients complete surgery, they will meet with an interventionist for eight, weekly one-on-one or group-delivered telehealth MBI sessions over a Zoom online telehealth platform. Sessions will be 75 minutes long (90 minutes for the first session). Sessions will be audio recorded and the interventionists will be supervised weekly.
- Participants will complete self-report assessments prior to surgery, two weeks after surgery (pre-intervention) and three months after surgery (post-intervention).
- After completing the intervention, participants will complete an intervention satisfaction survey and an audio-recorded 30-minute semi-structured interview over the phone to provide feedback regarding their experience with the intervention components and relevance to their postoperative recovery.
- We will code and analyze interview data continuously (every 2-4 interviews) until we reach data saturation and then integrate results from interviews and self-report surveys to determine relevant intervention adaptations, constructing a refined intervention protocol for pilot testing in a randomized controlled trial. We anticipate needing approximately 13-20 participants to complete interviews to reach data saturation (i.e. no new, relevant information obtained from interviews).
- Being tested
- Individual telehealth mindfulness, Group telehealth mindfulness
- Keywords
- Mindfulness, Telehealth, Mindfulness-based intervention
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual telehealth mindfulnessBehavioural
Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes).
Group telehealth mindfulnessBehavioural
Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Individual telehealth mindfulness | Experimental | Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist Receives: Behavioral: Individual telehealth mindfulness |
| Group Telehealth Mindfulness | Experimental | Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist Receives: Behavioral: Group telehealth mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Study Retention
Percentage of participants enrolled who complete the study
Measured: 3 months following lumbar spine surgery
Feasibility - Session Attendance
Percent of sessions attended out of 8
Measured: 3 months following lumbar spine surgery
Acceptability - Satisfaction With Intervention
Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55)
Measured: 3 months following lumbar spine surgery
Secondary outcomes (13)
Pain Bothersomeness
One item assessing how bothersome pain has been in the past 7 days from not at all = 0 to extremely = 4. A higher scores indicates higher pain bothersomeness.
Measured: 3 months postoperative
Pain Interference Short-form 4a
Pain Interference short-form 4a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain in day to day activities, work around the home, participation in social activities, and household chores over the past 7 days. Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower T-score indicates lower pain interference, or a better outcome.
Measured: 3 months postoperative
Overall Pain Intensity
1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with average pain intensity over the past 7 days rated on 0-10 scale with lower values indicating less pain, or better outcome.
Measured: 3 months postoperative
Back and Leg Pain Intensity
2 items assessing back and leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.
Measured: 3 months postoperative
Self-reported Opioid Medication Use
Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose.
Measured: 3 months postoperative
Anxiety Short Form 4a
Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful"). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome.
Measured: 3 months postoperative
Depression Short Form 4a
Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.
Measured: 3 months postoperative
Oswestry Disability Index
Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life). Scores range from 0-100. Lower scores indicate lower level of disability due to pain, a better outcome.
Measured: 3 months postoperative
Pain Catastrophizing Scale
13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse." Scores range from 0-52. Lower scores indicate lower pain catastrophizing, a better outcome.
Measured: 3 months postoperative
Pain Self-efficacy Questionnaire
10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain." Scores range from 0 to 60. Higher scores indicate greater pain self-efficacy, a better outcome.
Measured: 3 months postoperative
Perceived Stress Scale - 4
4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"). Scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.
Measured: 3 months postoperative
Tampa Scale for Kinesiophobia -13
13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise." Scores range from 13-52. Lower scores indicate lower levels of kinesiophobia, a better outcome.
Measured: 3 months postoperative
Five Facet Mindfulness Questionnaire - 15
15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores range from 1 to 5 (calculated by taking the average of the total sum score). Higher scores indicate higher levels of mindfulness, a better outcome.
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start21 Dec 2021
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low-back PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, nonrandomized, repeated measures design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Carrie Brintz, Vanderbilt University Medical Center
- Investigators
- Carrie E Brintz, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648683
- Sponsor's protocol ID
- 201486
- Other IDs
- K23AT011569
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2020
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT04648683
- Acronym / sponsor ID
- 201486
- Keywords
- Mindfulness, Telehealth, Mindfulness-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery.
This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.
Detailed description
We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth mindfulness-based intervention (MBI) for patients recovering from spine surgery. The procedures will be as follows:
- Recruit, consent and enroll up to 26 patients over a period of 8 months who are planning to have their first lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment will occur at a routine preoperative clinic visit or over the phone, with the spine surgeon's permission to approach the patient.
- Two weeks after enrolled patients complete surgery, they will meet with an interventionist for eight, weekly one-on-one or group-delivered telehealth MBI sessions over a Zoom online telehealth platform. Sessions will be 75 minutes long (90 minutes for the first session). Sessions will be audio recorded and the interventionists will be supervised weekly.
- Participants will complete self-report assessments prior to surgery, two weeks after surgery (pre-intervention) and three months after surgery (post-intervention).
- After completing the intervention, participants will complete an intervention satisfaction survey and an audio-recorded 30-minute semi-structured interview over the phone to provide feedback regarding their experience with the intervention components and relevance to their postoperative recovery.
- We will code and analyze interview data continuously (every 2-4 interviews) until we reach data saturation and then integrate results from interviews and self-report surveys to determine relevant intervention adaptations, constructing a refined intervention protocol for pilot testing in a randomized controlled trial. We anticipate needing approximately 13-20 participants to complete interviews to reach data saturation (i.e. no new, relevant information obtained from interviews).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, nonrandomized, repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Individual telehealth mindfulness | Experimental | Behavioral: Individual telehealth mindfulnessTelehealth mindfulness sessions delivered one-on-one with mindfulness therapist |
| Group Telehealth Mindfulness | Experimental | Behavioral: Group telehealth mindfulnessTelehealth mindfulness sessions delivered in a small-group format with mindfulness therapist |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English-speaking adults
- Between the ages of 18 and 90
- Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
- Scheduled for their first lumbar spine surgery
- Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
Key exclusion criteria (9 listed)
- Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
- Having surgery for the primary indication of a spinal deformity
- Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis
- Diagnosis of Alzheimer's disease or another form of dementia
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 |
|---|---|---|
| Individual telehealth mindfulnessParticipants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes). | Behavioural | Individual telehealth mindfulness |
| Group telehealth mindfulnessParticipants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each. | Behavioural | Group Telehealth Mindfulness |
Primary outcome
Feasibility - Study Retention
Time frame: 3 months following lumbar spine surgery
Percentage of participants enrolled who complete the study
Feasibility - Session Attendance
Time frame: 3 months following lumbar spine surgery
Percent of sessions attended out of 8
Acceptability - Satisfaction With Intervention
Time frame: 3 months following lumbar spine surgery
Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55)
13 secondary outcomes
Pain Bothersomeness
Time frame: 3 months postoperative
Pain Interference Short-form 4a
Time frame: 3 months postoperative
Overall Pain Intensity
Time frame: 3 months postoperative
Back and Leg Pain Intensity
Time frame: 3 months postoperative
Self-reported Opioid Medication Use
Time frame: 3 months postoperative
Anxiety Short Form 4a
Time frame: 3 months postoperative
Depression Short Form 4a
Time frame: 3 months postoperative
Oswestry Disability Index
Time frame: 3 months postoperative
Pain Catastrophizing Scale
Time frame: 3 months postoperative
Pain Self-efficacy Questionnaire
Time frame: 3 months postoperative
Perceived Stress Scale - 4
Time frame: 3 months postoperative
Tampa Scale for Kinesiophobia -13
Time frame: 3 months postoperative
Five Facet Mindfulness Questionnaire - 15
Time frame: 3 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carrie E Brintz, PhD 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 Individual telehealth mindfulness and Group telehealth mindfulness in people with Chronic Low-back Pain and Postsurgical Pain, 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 8 inclusion and 9 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 26 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 26 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility - Study Retention (time frame: 3 months following lumbar spine surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.