Meditation and Exercise to Treat Chronic Back Pain (MedExT)
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|ClinicalTrials.gov Identifier: NCT03324659|
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Behavioral: Exercise and Meditation Behavioral: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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.
- 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).
- 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.
- 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
- 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.
- 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
- 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.
- 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
- 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.
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
|Contact: Matthew C. Kostek, PhDfirstname.lastname@example.org|
|Contact: Anna Polaski, BSemail@example.com|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15282|
|Contact: Anna M Polaski, BS|
|Principal Investigator: Matt Kostek, PhD|
|Principal Investigator:||Matthew C. Kostek, PhD||Duquesne University|
|Principal Investigator:||Benedict J Kolber, PhD||Duquesne University|
|Principal Investigator:||Eric Helm, MD||University of Pittsburgh|