Clinical trial NCT03324659: Meditation and Exercise to Treat Chronic Back Pain
Official title: Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Mindfulness
Exercise
Meditation
Back pain
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2017-10-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. The investigators hypothesize that a combination treatment reduces disability and pain more than the control intervention.

Detailed description: Exercise and mindfulness based mediation can both produce analgesic effects in patients with chronic pain, but the mechanisms are not clear.

Combining treatments could produce analgesic effects that are additive, synergistic, or counteractive to each other. Here, the investigators examine the effects of a 4-week intervention in patients with chronic low back pain. Patients are assigned to a meditation/exercise group or a control group. The investigators will measure pain and disability using a variety of tools including surveys (disability, anxiety, mindfulness, and pain), pain VAS scales, and quantitative sensory testing.

Eligibility criteria: Inclusion Criteria:

1. Presence of clinically diagnosed nonspecific low back pain for at least 6 months
2. Body mass index within the normal to overweight range (18.5-29.9)
3. Resting heart rate 60 to 100 beats per minute
4. Resting blood pressure less than or equal to 140/90
5. Able to independently ambulate community distances without external support (e.g., walker, cane)

   Exclusion Criteria:
6. Age less than 18 or greater than 60 years
7. BMI ≥ 30 or ≤ 18.4
8. Cardiovascular or respiratory disease
9. Neurological disease, unrelated to low back pain
10. Radicular low back pain
11. Back pain associated with neuropathy
12. Diabetes mellitus, Types 1 and 2
13. Diagnosed with a chronic pain condition, unrelated to low back pain
14. Acute pain
15. Regular participation in high intensity athletic/sporting activities
16. Sedentary lifestyle
17. Currently pregnant
18. Current cigarette smoker
19. On-going litigation associated with back pain
20. Inability to walk independently without external support (e.g. walker).
21. Regular participation in meditation techniques or training in Mindfulness-based stress reduction

Primary outcomes:
measure: Change in Roland Morris Disability Questionnaire
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change in Cutaneous Sensation
timeFrame: baseline and 4 weeks
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: baseline and 4 weeks
measure: Freiburg Mindfulness Inventory
timeFrame: baseline and 4 weeks
measure: VAS back pain (intensity & unpleasantness)
timeFrame: baseline, daily (pre and post intervention), and 4 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: baseline and 4 weeks
measure: Change in Pressure Sensation
timeFrame: baseline and 4 weeks
measure: Change in Heat unpleasantness
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Matthew C. Kostek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duquesne University
name: Benedict J Kolber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Eric Helm, MD
role: PRINCIPAL_INVESTIGATOR
References: