Chronic Lower Back Pain (CLBP)
Conditions
Keywords
Veterans, Telehealth based intervention, Brief Pain Reprocessing Therapy
Brief summary
This research is studying whether a Zoom-based behavioral intervention may have an impact as a treatment for Veterans with Chronic Low Back Pain (CLBP). The study will examine: * The acceptability of the Brief Pain Reprocessing Therapy (BPRT) intervention * The feasibility of the BPRT intervention * The safety of the BPRT intervention
Detailed description
This study will take place remotely and there will be no on-site visits.
Interventions
BEHAVIORALBrief Pain Reprocessing Therapy (BPRT)
Participants will have three 90-minute behavioral intervention sessions over a 3-week period, completing 35 days of brief daily assessments, and one additional set of questionnaires. Participants will also complete study questionnaires at 1, 2, 3, and 6 months after attending the 3 behavioral intervention sessions.
Sponsors
University of Michigan
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Low back pain that has lasted greater than 6 months, with pain on at least half of these days * Must provide verification of being an Armed Service Veteran. * Able to read, write and speak English * Internet access and audio-conferencing capability (e.g., Zoom meetings by phone or computer) in the home
Exclusion criteria
* Self-reported evidence of a separate medical condition (e.g., rheumatoid arthritis), acute injury in the past 12 months (e.g., self-reported spinal fracture), self-reported loss of bowel or bladder control in the past year (which may indicate presence of cauda equina syndrome), or evidence of presence of a metastasizing cancer requiring treatment * Pending surgical procedures or interventional therapies (e.g., spinal injections) within the next 12 months * Confirmed/suspected pregnancy * Evidence of other conditions that may preclude participants from understanding or being able to participate in study procedure (e.g., schizoaffective disorder, suspected or diagnosed dementia) * Currently receiving cognitive-behavioral therapy or other psychological therapies for pain * Open litigation in the past 1 year, as assessed in preliminary study screening. * Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be assessed by the Patient Global Impression of Change (PGIC) | Baseline, up to day 35 post treatment | There is 1 question that participants will select from 1 (very much improved) - 7 (very much worse). |
| Safety assessed by the number of Adverse events and Serious adverse events T6 (Day 60) - T9 (Day 210) | T6 (Day 60) - T9 (Day 210) | Adverse events will be classified as serious or non-serious (per protocol). These will be assessed by items such as death, life-threatening event, hospitalization, emergency room visits, persistent or significant disability/incapacity, suicide plans or attempts. |
| Acceptability of and satisfaction with treatment base on the mean scores on the Treatment Evaluation Inventory (TEI-SF) assessed at T5 (approximately day 35) | Approximately day 35 (post treatment) | The TEI-SF is a validated instrument for behavioral interventions. There are 9 questions that participants answer from 1 (strongly disagree) - 5 (strongly agree) with a range of (9-45) with a higher score indicating greater acceptability. Scores at 27 or above will denote moderate acceptability of the intervention. |
| Feasibility will be accessed by participant adherence | Up to approximately day 35 (post treatment) | Adherence to the intervention will be determined by at least 80% attendance of intervention sessions, completion of daily assessment, and self-reported adherence to home-base exposure practices, completion of pre/post session and pre/post interventions. |
| Feasibility will be accessed by feedback from the Qualitative Interviews | Approximately day 35 (post treatment) | Qualitative Interviews will occur after conclusion of the intervention period to address areas of improvement in future iterations of the intervention. |
| Safety will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS 29) pain intensity | Baseline, up to day 35 post treatment | There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable). |
| Safety will be assessed by the PROMIS Depression scale | Baseline, up to day 35 post treatment | Participants will answer 4 questions 1 (never) -5 (always). There is a range of scores from 4-20 with a higher score indicating higher levels of depression. |
| Safety will be assessed by the PROMIS Anxiety scale | Baseline, up to day 35 post treatment | Participants will answer 4 questions 1 (never) -5 (always). There is a range of scores from 4-20 with a higher score indicating higher levels of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from T1 (day 1) to T6 (Day 60) in Tampa Scale of Kinesiophobia (TSK) | T1 (Day 1) - T6 (Day 60) | There are 17 questions that participants will select from a score of 1 (strongly disagree) - 4 (strongly agree). A total score is calculated after reversing items 4, 8, 12 and 16. The scores range between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia. |
| Change from T1 to T6 (Day 60) pain intensity | T1 (Day 1) - T6 (Day 60) | There is 1 question that participants will answer pain level from 0 (not at all) - 10 (worst pain imaginable). |
| Change from T1 to T6 (Day 60) PROMIS Pain Interference | T1 (Day1) - T6 (Day 60) | Participants will answer 4 questions 1 (not at all) -5 (very much). There is a range of scores from 4-20 with a higher score indicating higher levels of interference. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Sturgeon, PhD
University of Michigan
Outcome results
None listed