Meditation and Exercise to Treat Chronic Back Pain (MedExT)

• ClinicalTrials.gov Identifier: NCT03324659
• Recruitment Status: Completed
• First Posted: October 30, 2017
• Last Update Posted: April 5, 2021
• Sponsor: Duquesne University
• Collaborator: University of Pittsburgh
• Information provided by (Responsible Party): Matthew Kostek, Duquesne University

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.

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

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

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

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

• 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

Locations

United States, Pennsylvania

Duquesne University

Pittsburgh, Pennsylvania, United States, 15282

Sponsors and Collaborators

Duquesne University

University of Pittsburgh

Investigators

• 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

• Responsible Party: Matthew Kostek, Assistant Professor, Duquesne University
• ClinicalTrials.gov Identifier: NCT03324659
• Other Study ID Numbers: Protocol50
• First Posted: October 30, 2017
• Last Update Posted: April 5, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations