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Meditation and Exercise to Treat Chronic Back Pain (MedExT)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise and Meditation
Control
Sponsored by
Duquesne University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Mindfulness, Exercise, Meditation, Back pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duquesne University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exercise and Meditation

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Roland Morris Disability Questionnaire
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 Outcome Measures

Change in Cutaneous Sensation
Subjects will be examined using cutaneous sensory filaments on the forearm with data recorded in grams.
Fear Avoidance Beliefs Questionnaire
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
Freiburg Mindfulness Inventory
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.
VAS back pain (intensity & unpleasantness)
Participants will be asked to rate their current level of back pain intensity on a Visual Analog Scale (VAS) ranging from 0 to 10
State-Trait Anxiety Inventory (STAI)
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.
Change in Pressure Sensation
Subjects will be examined using a pressure algometer to determine a pressure pain threshold, measured in Newtons
Change in Heat unpleasantness
Subjects will be examined using a heat block with a determined temperature threshold. Subjects will report unpleasantness using a VAS scale.

Full Information

First Posted
October 17, 2017
Last Updated
April 1, 2021
Sponsor
Duquesne University
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03324659
Brief Title
Meditation and Exercise to Treat Chronic Back Pain
Acronym
MedExT
Official Title
Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duquesne University
Collaborators
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Mindfulness, Exercise, Meditation, Back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Meditation
Arm Type
Experimental
Arm Description
The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and Meditation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
Change in Roland Morris Disability Questionnaire
Description
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).
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in Cutaneous Sensation
Description
Subjects will be examined using cutaneous sensory filaments on the forearm with data recorded in grams.
Time Frame
baseline and 4 weeks
Title
Fear Avoidance Beliefs Questionnaire
Description
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
Time Frame
baseline and 4 weeks
Title
Freiburg Mindfulness Inventory
Description
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.
Time Frame
baseline and 4 weeks
Title
VAS back pain (intensity & unpleasantness)
Description
Participants will be asked to rate their current level of back pain intensity on a Visual Analog Scale (VAS) ranging from 0 to 10
Time Frame
baseline, daily (pre and post intervention), and 4 weeks
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
baseline and 4 weeks
Title
Change in Pressure Sensation
Description
Subjects will be examined using a pressure algometer to determine a pressure pain threshold, measured in Newtons
Time Frame
baseline and 4 weeks
Title
Change in Heat unpleasantness
Description
Subjects will be examined using a heat block with a determined temperature threshold. Subjects will report unpleasantness using a VAS scale.
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew C. Kostek, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benedict J Kolber, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Helm, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duquesne University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Meditation and Exercise to Treat Chronic Back Pain

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