Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2018-01-26
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mindfulness Meditation for Chronic Low Back Pain in Older Adults
NCT00494845
Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain
NCT00594243
Meditation-CBT for Opioid-treated Chronic Low Back Pain
NCT01775995
Reducing Sedentary Time in Chronic Low Back Pain: Sedentary Intervention Using Motivational Interviewing and Technology
NCT04257539
Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
NCT03986489
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise and Meditation
The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks.
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.
Control
The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pittsburgh
OTHER
Duquesne University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matthew Kostek
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew C. Kostek, PhD
Role: PRINCIPAL_INVESTIGATOR
Duquesne University
Benedict J Kolber, PhD
Role: PRINCIPAL_INVESTIGATOR
Duquesne University
Eric Helm, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duquesne University
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Protocol50
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.