Meditation and Exercise to Treat Chronic Back Pain (MedExT)

Duquesne University

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Behavioral: Control; Behavioral: Exercise and Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT03324659

Protocol50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Exercise and Meditation

Experimental group

Description:

The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks.

Treatment:

Behavioral: Exercise and Meditation

Control

Sham Comparator group

Description:

The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.

Treatment:

Behavioral: Control