Chronic Pain Syndrome
Conditions
Keywords
chronic pain, rheumatoid arthritis, fibromyalgia, neuropathy, neuralgia, pain
Brief summary
The overall objective of this study is to better understand how Mindfulness-based Stress Reduction (MBSR) is the most helpful in terms of management of chronic pain symptoms. The studies hypothesis is that an Interventional Response Phenotyping study (light phenotyping) can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic pain disorders.
Detailed description
Participants enrolled in this study will receive 8 weeks of MBSR therapy and complete surveys at various time points pre-treatment - post treatment.
Interventions
BEHAVIORALMBSR treatment
Participants will complete pre-treatment surveys followed by 8-weekly 2-hour group sessions and one 4-hour retreat (may take place virtually or in-person). Participants will also be asked to practice daily formal mindfulness at home using assigned audio recordings of 30-45 minute guided mindfulness exercises. Participants will complete surveys during treatment as well as after treatment and then at 2 months follow-up.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for MBSR Study * Ages 18+ * Any form of self-reported chronic pain (except cancer related pain)
Exclusion criteria
for MBSR study * Unable to speak and write English * Visual or hearing difficulties that would preclude participation * Chronic pain from cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS physical function 6b | 8 weeks (after MSBR) | Physical Function 6b questionnaire will assess self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from without any difficulty to unable to do or not at all to cannot do. The minimum raw summed score is 6 and the maximum score is 30. Lower scores suggest better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS pain intensity, anxiety, pain interference | Baseline (pre-treatment), 8 weeks | Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a. Measure of the amount of interference pain causes in life; range 6-30; higher is worse |
| Change in Pain Catastrophizing Scale (PCS) | Baseline (pre-treatment), 8 and 12 weeks | The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale (not at all to all the time). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome. |
| Pain Catastrophizing Score; measured with Pain Catastrophizing Scale | 8 weeks (after MSBR) | The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale (not at all to all the time). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome |
| Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8 | Baseline, 8 weeks (after MSBR) | CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values. |
Countries
United States
Outcome results
None listed