Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Meditation and Exercise to Treat Chronic Back Pain (MedExT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324659
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Matthew Kostek, Duquesne University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Exercise and Meditation Behavioral: Control Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Exercise and Meditation
The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks.
 Behavioral: Exercise and Meditation
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.
Sham Comparator: Control
The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.
 Behavioral: Control
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324659


Contacts
Layout table for location contacts
Contact: Matthew C. Kostek, PhD 412-396-5546 kostekm@duq.edu
Contact: Anna Polaski, BS 412-444-8634 polaskia@duq.edu

Locations
Layout table for location information
United States, Pennsylvania
Duquesne University Recruiting
Pittsburgh, Pennsylvania, United States, 15282
Contact: Anna M Polaski, BS         
Principal Investigator: Matt Kostek, PhD         
Sponsors and Collaborators
Duquesne University
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Matthew C. Kostek, PhD Duquesne University
Principal Investigator: Benedict J Kolber, PhD Duquesne University
Principal Investigator: Eric Helm, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Matthew Kostek, Duquesne University:
Study Protocol  [PDF] October 24, 2017
Statistical Analysis Plan  [PDF] December 21, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Matthew Kostek, Assistant Professor, Duquesne University
ClinicalTrials.gov Identifier: NCT03324659    
Other Study ID Numbers: Protocol50
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Kostek, Duquesne University:
Mindfulness
Exercise
Meditation
Back pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations