Low Back Pain Clinical Trial
Official title:
Mindfulness Meditation for Chronic Low Back Pain in Older Adults
Verified date | January 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Among mind-body therapies, there is evidence for an association between pain reduction and mindfulness meditation. Mindfulness meditation provides a potentially safe, effective, nonpharmacologic, noninvasive, simple method for pain relief and increased function that could be used for the frailest older adult. Additionally, mindfulness meditation addresses the multiple dimensions that are affected by chronic pain. The primary objective of this study is to determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in community dwelling older adults with chronic low back pain. Using a randomized controlled experimental design, 80 community dwelling older adults ≥ age 65 with chronic low back pain will receive either (1) the MBSR program, or (2) an 8-week education program. Prior to initiating the program, immediately after the last program session, and 6 months later, the following parameters will be assessed: (1) pain severity, (2) disability/physical function, (3) objectively measured physical performance, (4) psychosocial function (including mood, self-efficacy, self-rated health, coping, stress, quality of life (QOL), mindfulness and pain-related fear), (5) sleep, (6) pain-related appetite reduction and, (7) time and frequency of meditation. All measures are self-report except for the physical performance measure.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 65 years of age or older - Have intact cognition (Mini-Mental Status Exam (MMSE) >23) - CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months - Speak English. Exclusion Criteria: - Do not meet the above inclusion criteria - Have previously participated in a mindfulness meditation program - Have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain, - Are non-ambulatory, or have severely impaired mobility (i.e., require the use of a walker): since measurement of physical performance in the proposed study includes timed chair rise, gait velocity, and standing balance, conditions other than back pain that could negatively impact these measures may confound our study results - Severe visual or hearing impairment: since this study will involve questionnaires and telephone evaluations, severe visual and/or hearing impairments may interfere with data collection - Significant pain in parts of the body other than the lower back or acute back pain: since we will be specifically evaluating chronic low back pain, we do not want to confound the outcome data with pain from other areas or with acute pain. Thus only subjects with chronic back pain severity that is greater than pain severity elsewhere in the body will be included - Acute or terminal illness: To insure weekly participation and a six month follow-up, subjects with an acute or terminal illness will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Center for Research Resources (NCRR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in community dwelling older adults with chronic low back pain. | One year | ||
Primary | Determine the impact of an 8-week mindfulness-based stress reduction program on psychosocial function, sleep, and appetite in older adults with chronic low back pain. | One year | ||
Primary | Determine the impact of time and frequency of mindfulness meditation on physical function and pain severity. | One year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03916705 -
Thoraco-Lumbar Fascia Mobility
|
N/A | |
Completed |
NCT04007302 -
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT03600207 -
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
|
N/A | |
Completed |
NCT04284982 -
Periodized Resistance Training for Persistent Non-specific Low Back Pain
|
N/A | |
Recruiting |
NCT05600543 -
Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain
|
N/A | |
Withdrawn |
NCT05410366 -
Safe Harbors in Emergency Medicine, Specific Aim 3
|
||
Completed |
NCT03673436 -
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
|
||
Completed |
NCT02546466 -
Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
|
N/A | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05156242 -
Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.
|
N/A | |
Recruiting |
NCT04673773 -
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
|
N/A | |
Completed |
NCT06049251 -
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises
|
N/A | |
Completed |
NCT06049277 -
Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain
|
N/A | |
Completed |
NCT04980469 -
A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
|
N/A | |
Completed |
NCT04055545 -
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
|
N/A | |
Recruiting |
NCT05552248 -
Assessment of the Safety and Performance of a Lumbar Belt
|
||
Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
Completed |
NCT05801588 -
Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life
|
N/A | |
Completed |
NCT05811143 -
Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
|