Low Back Pain
Conditions
Keywords
chronic low back pain, mindfulness meditation, cognitive therapy, mindfulness-based cognitive therapy, efficacy, mechanisms, coping
Brief summary
Up to 80% of Australians experience back pain and 10% have significant disability as a result. There is a critical need for the development and evaluation of innovative treatments that have the capacity to target the multidimensional nature of chronic low back pain. This study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately lead to streamlined interventions designed to efficiently maximise benefit.
Detailed description
Up to 80% of Australians experience back pain and 10% have significant disability as a result. This translates into substantial economic cost with far reaching psychological, emotional and social implications. Unfortunately, the treatment options for chronic low back pain (CLBP) are limited and typical medical/pharmacological approaches entail potentially serious side-effects (e.g., opioid addiction). There is a critical need for the development and evaluation of innovative interventions that have the capacity to target the multidimensional nature of CLBP. Research indicates that psychosocial interventions for CLBP are viable treatment approaches that entail few (if any) deleterious side effects and can have benefit beyond pain reduction. Cognitive Therapy (CT) and Mindfulness Meditation (MM) have both been found to be feasible and effective for CLBP. A promising recently developed treatment that combines aspects of CT and MM is Mindfulness-Based Cognitive Therapy (MBCT). MBCT has been successfully applied to problems such as depression and headache; however, this approach has not been investigated for CLBP. Thus, the current study is a randomised controlled trial (RCT) designed to examine the effects and mechanisms (i.e., how and for whom do these treatments work) of CT, MM, and MBCT for CLBP. Brain state data (electroencephalogram (EEG)) as well as self-report data will be examined to investigate the potential unique and shared mechanisms underlying treatment effects. Furthering the field's understanding of these treatments and their mechanisms will lead to the development of streamlined interventions designed to efficiently maximise benefit for individuals with CLBP, and that optimise relief from suffering.
Interventions
OTHERCognitive Therapy
OTHERMindfulness Meditation
OTHERMindfulness-Based Cognitive Therapy
Sponsors
University of Washington
University of Alabama at Birmingham
Rush University Medical Center
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * Chronic pain of the low back (≥3 months) that is the primary source of reported pain * Average pain intensity of ≥4 on a 10-point scale * If currently taking analgesic or psychotropic medications, they must have been stabilised for ≥4 weeks prior to this study * Be able to read, speak and understand English * Be able to attend a weekly 2-hour therapy session for 8 concurrent weeks
Exclusion criteria
* Cognitive impairment, uncontrolled psychotic symptoms or current elevated suicidal ideation as this may interfere with group-delivered therapy (as evidenced by the 6-item screener) * Chronic pain due to malignancy * History of a medical condition that could produce an abnormal EEG and interfere with the tests of the effects of treatment on EEG (e.g., epilepsy, history of traumatic brain injury) * Currently receiving other psychosocial pain treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain interference PROMIS scale | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain catastrophizing assessed via the Pain Catastrophizing Scale | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain catastrophizing is assessed via the Pain Catastrophizing Scale |
| Mindfulness assessed via the FFMQ | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in mindfulness is assessed via the FFMQ |
| Pain acceptance assessed via the CPAQ | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain acceptance is assessed via the CPAQ |
| Pain intensity assessed via the numerical rating scale (NRS) | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain intensity is assessed via the numerical rating scale (NRS) |
| Emotional functioning PROMIS scale | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in emotional functioning is assessed via the PROMIS scale |
| Physical functioning PROMIS scale | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in physical functioning is assessed via the PROMIS scale |
| Delta, theta, alpha, beta, and gamma bands assessed via EEG | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in brain state data is assessed via EEG |
| Psychological functioning PROMIS scale | pre to post-treatment (at least 8 weeks) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in psychological functioning is assessed via the PROMIS scale |
Countries
Australia
Outcome results
None listed