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Clinical Trials/NCT03324659
NCT03324659
Completed
Not Applicable

Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain

Duquesne University1 site in 1 country42 target enrollmentJanuary 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Duquesne University
Enrollment
42
Locations
1
Primary Endpoint
Change in Roland Morris Disability Questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2018
End Date
June 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Kostek

Assistant Professor

Duquesne University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Age less than 18 or greater than 60 years
  • BMI ≥ 30 or ≤ 18.4
  • Cardiovascular or respiratory disease
  • Neurological disease, unrelated to low back pain
  • Radicular low back pain
  • Back pain associated with neuropathy
  • Diabetes mellitus, Types 1 and 2
  • Diagnosed with a chronic pain condition, unrelated to low back pain
  • Regular participation in high intensity athletic/sporting activities
  • Sedentary lifestyle

Outcomes

Primary Outcomes

Change in Roland Morris Disability Questionnaire

Time Frame: baseline and 4 weeks

The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability).

Secondary Outcomes

  • Change in Cutaneous Sensation(baseline and 4 weeks)
  • Fear Avoidance Beliefs Questionnaire(baseline and 4 weeks)
  • Freiburg Mindfulness Inventory(baseline and 4 weeks)
  • VAS back pain (intensity & unpleasantness)(baseline, daily (pre and post intervention), and 4 weeks)
  • State-Trait Anxiety Inventory (STAI)(baseline and 4 weeks)
  • Change in Pressure Sensation(baseline and 4 weeks)
  • Change in Heat unpleasantness(baseline and 4 weeks)

Study Sites (1)

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