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Completed

NCT Number: NCT03324659

Meditation and Exercise to Treat Chronic Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Acute pain
  • Regular participation in high intensity athletic/sporting activities
  • Sedentary lifestyle
  • Currently pregnant
  • Current cigarette smoker
  • On-going litigation associated with back pain
  • Inability to walk independently without external support (e.g. walker).
  • Regular participation in meditation techniques or training in Mindfulness-based stress reduction

Treatment and study plan

Exercise and Meditation

Behavioral

The Exercise and Meditation group will listen to recorded meditations (15 minutes) that are based on mindfulness. They will then walk on a treadmill for 30 minutes at a moderate intensity. The intervention is completed five days per week for four weeks.

Control

Behavioral

The Control group will listen to a recorded audio book for 15 minutes, They will then sit quietly for 30 minutes. The intervention is completed five days per week for four weeks.

Primary outcomes

  1. 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

  1. Change in Cutaneous Sensation

    Time frame: baseline and 4 weeks

    Subjects will be examined using cutaneous sensory filaments on the forearm with data recorded in grams.

  2. Fear Avoidance Beliefs Questionnaire

    Time frame: baseline and 4 weeks

    The Fear-Avoidance Beliefs Questionnaire (FABQ) is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception, a model created in attempts to explain why some patients with acute painful conditions can recover while other patients develop chronic pain from such conditions. The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. This questionnaire consists of 16 items, with each item scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs

  3. Freiburg Mindfulness Inventory

    Time frame: baseline and 4 weeks

    The FMI is a 14-item questionnaire for measuring mindfulness. It is most suitable in generalized contexts, where knowledge of the Buddhist background of mindfulness cannot be expected. The 14 items cover all aspects of mindfulness. The purpose is to characterize the experience of mindfulness. The subject is asked to answer every statement as honestly and spontaneously as possible. Each statement is scored on a 1 to 4 scale and a composite score is calculated from all statements.

  4. VAS back pain (intensity & unpleasantness)

    Time frame: baseline, daily (pre and post intervention), and 4 weeks

    Participants will be asked to rate their current level of back pain intensity on a Visual Analog Scale (VAS) ranging from 0 to 10

  5. State-Trait Anxiety Inventory (STAI)

    Time frame: baseline and 4 weeks

    The STAI is an introspective psychological inventory consisting of 40 self-report items pertaining to anxiety affect. It distinguishes between a person's state and trait anxiety levels. The A-Trait and A-State scales comprise 20 items each, scored on a 4-point Likert-type response scale. Higher STAI scores suggest higher levels of anxiety.

  6. Change in Pressure Sensation

    Time frame: baseline and 4 weeks

    Subjects will be examined using a pressure algometer to determine a pressure pain threshold, measured in Newtons

  7. Change in Heat unpleasantness

    Time frame: baseline and 4 weeks

    Subjects will be examined using a heat block with a determined temperature threshold. Subjects will report unpleasantness using a VAS scale.

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

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

Acronym: MedExT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2017
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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