Chronic Musculoskeletal Pain
Conditions
Keywords
Chronic pain, Brief intervention, Remote
Brief summary
Researchers at Florida State University are investigating how the length of treatment influences outcomes for individuals with chronic musculoskeletal pain. The goal is to identify the most effective balance between treatment duration and pain relief. There are three treatment conditions in this study: two different brief pain management trainings and one standard-length training. Participants will be randomized to either of the brief trainings, attending a single, 2-hour, online training session, in which a trained facilitator will teach pain management techniques that are backed by research. If randomized to receive the standard-length training, participants will attend eight, 2-hour, online training session over eight weeks, in which a trained facilitator will also teach research-backed pain management techniques. Short surveys will be required at seven different time points: before starting treatment, immediately after the pain-management training, and then 2, 6, 12, 24, and 36 weeks after the training.
Interventions
B-MORE is a 2-hour, single session adaptation of the traditional MORE program.
BEHAVIORALEmpowered Relief
ER is an evidence-based 2-hour single session intervention for chronic pain.
MORE is an 8-week evidence-based treatment for chronic pain.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) having a chronic musculoskeletal pain condition, (2) average pain of ≥ 3 in the previous week, (3) willingness to engage with study assessments and interventions, (4) understanding English instructions fluently, and (5) being 18 and above.
Exclusion criteria
* (1) unable to consent because of physical or mental incapacity, (2) have previous, formal mindfulness training (e.g., MBSR) or previously receiving Empowered Relief, (3) have pain from a current cancer diagnosis or cancer-related treatment, (4) unstable illness that may interfere with treatment, (5) had surgery within the previous three months, and (6) had pain relieving injections, such as cortisone or hyaluronate, within the previous three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | 6 months | Recruitment feasibility will be assessed via total enrollment and randomization numbers within the first 6 months of the study. Study team projects that it will be feasible to recruit and randomize 30 adults with CMP within 6 months. |
| Treatment Adherence & Acceptability | From baseline to 9-month follow-up | Adherence (percentage of total treatment time attended) will be better for the single-session interventions, but all three conditions will be rated as highly acceptable (as measured by the Theoretical Framework of Acceptability; TFA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Pain Intensity | From baseline to 9-month follow-up | A 3-item questionnaire using a 5-point Likert-like scale (1- had no pain to 5- very severe). Questions include In the past 7 days, How intense was your pain at its worst? |
| PROMIS - Pain Interference | From baseline to 9-month follow-up | An 8-item questionnaire using a 5-point Likert-like scale (1- not at all to 5- very much). Questions include In the past 7 days, how much did pain interfere with work around the home?. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Catastrophizing Scale | From baseline to 9-month follow-up | The Brief PCS is a validated, 6-item questionnaire on which participants rate their thoughts and feelings about pain on a 5-point Likert scale, ranging from 0 (Not at all) to 4 (All the time). |
| Five Facets of Mindfulness Questionnaire | From baseline to 9-month follow-up | A validated, 15-item questionnaire assessing trait mindfulness. Questions include I do jobs or tasks automatically without being aware of what I'm doing. |
| PROMIS - Depression | From baseline to 9-month follow-up | A 4-item questionnaire using a 5-point Likert-like scale (1- never to 5- very much). Statements include In the past 7 days, I felt worthless. |
| Mindful Reappraisal of Pain Sensations | From baseline to 9-months | A validated, 9-item questionnaire assessing one's ability to mindfully reappraise arising pain sensations. Questions include I step back from the pain and see it as something outside of me. |
| Acute Clinical Effects of Treatment Sessions | Immediately before and after each training session. | Acute pain intensity, pain unpleasantness, anxiety, and desire for pain medication will all be measured via a 0-10 numeric rating scale. |
| Savoring Beliefs Inventory | From baseline to 9-month follow-up | A validated measure to assess positive savoring habits. Questions include Before a good thing happens, I look forward to it in ways that give me pleasure in the present. |
| PROMIS - Anxiety | From baseline to 9-month follow-up | A 4-item questionnaire using a 5-point Likert-like scale (1- never to 5- almost always). Statements include In the past 7 days, my worries overwhelmed me. |
| PROMIS - Sleep Disturbance | From baseline to 9-month follow-up | A 6-item questionnaire using a 5-point Likert scale |
| World Health Organization - Quality of Life | From baseline to 9-month follow-up. | A 2-question assessment to measure self-reported quality of life. Participants will be asked How would you rate your quality of life? with a 5-point Likert scale (with 1- very poor to 5-very good). Participants will also be asked How satisfied are you with your health? with a 5-point Likert like scale (with 1-very dissatisfied to 5-very satisfied). |
Countries
United States
Contacts
Primary ContactAdam Hanley, PhD
Outcome results
None listed