An interventional study of Exercise and Meditation and Control in Chronic Low Back Pain, sponsored by Duquesne University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by Duquesne University · Not applicable, Interventional, and Treatment
Among 307 studies in Back Pain with a site in United States — 38 open to participants now, 51 under way, 4 of them phase 3. Back Pain · United States.
Among the 307 studies in Back Pain with a site in United States, this one is the 173rd largest by enrollment of the 262 interventional ones that give a count, is one of 20 that started in 2018, is one of 163 with no phase, and was the 156th registered.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
Browse Back Pain studies →38 of the 307 studies in Back Pain with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
University of Houston · Sites in United States
Northwestern University · Sites in United States, Thailand, Ukraine
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 68 Back Pain studies recruiting now, 29 (43%) set no upper age limit and 32 (47%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
307 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 29 · Phase 3 33 · Phase 4 30
First in 1997; this study’s year is marked. 20 started in 2018.
This study's enrollment of 42 is below the median of 70 across 593 interventional studies indexed under Back Pain.
Median enrollment 76 across the 262 interventional studies, 133 across the 44 observational. Of the 228 that completed or were terminated, 105 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
107 of 307 have an industry lead sponsor. The 10 most frequent:
Duquesne University is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Duquesne University has 1 study filed under Back Pain — fewer than ten, so there is no comparison to draw.
20 of the studies in Back Pain with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05058287Phase 3Hospital for Special Surgery, New YorkLumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression | 2026-12-31 |
| NCT06350981Phase 3Foundation for Orthopaedic Research and EducationAnalgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion | 2027-01-01 |
| NCT05052541Phase 3University of Colorado, DenverSafety and Efficacy of Oral Cannabis in Chronic Spine Pain | 2027-06 |
| NCT07125027National University of Natural MedicineA Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE | 2026-11 |
| NCT06007976Mayo ClinicLLLT to Reduce Low Back Pain | 2026-12 |
Among the 307 studies in Back Pain with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's enrollment of 42 is below the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →Duquesne University is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Compared within Back Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.
Behavioral: Control
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.
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
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
Change in Cutaneous Sensation
Subjects will be examined using cutaneous sensory filaments on the forearm with data recorded in grams.
Time frame: baseline and 4 weeks
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
Time frame: baseline and 4 weeks
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.
Time frame: baseline and 4 weeks
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
Time frame: baseline, daily (pre and post intervention), and 4 weeks
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.
Time frame: baseline and 4 weeks
Change in Pressure Sensation
Subjects will be examined using a pressure algometer to determine a pressure pain threshold, measured in Newtons
Time frame: baseline and 4 weeks
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.
Time frame: baseline and 4 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Mar 2019, 14 months.
Of 259 non-industry interventional studies with no phase under Back Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 14 months is above that.
Counting every sponsor, half of 294 studies reached it within 13 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Duquesne University