Lower Back Pain Clinical Trial
— RESTOREOfficial title:
Restorative Exercise for Strength Training and Operational Resilience
NCT number | NCT02132910 |
Other study ID # | 380491 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | August 7, 2015 |
Verified date | November 2019 |
Source | Defense and Veterans Center for Integrative Pain Management |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to learn about the effect of integrative therapies on chronic or
recurrent low back pain.
The intervention called RESTORE (Restorative Exercises for Strength Training and Operational
Resilience) is based on a series of gentle stretching and strengthening exercises
incorporating breath-work and mindfulness. The study is designed to discover the impact of
RESTORE on pain levels, physical function, and behavioral health.
Status | Completed |
Enrollment | 68 |
Est. completion date | August 7, 2015 |
Est. primary completion date | August 7, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 68 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with lower back pain with a pain score of 4 or higher on DVPRS for 3 months - Male or female - Age 18-68* - Able to read and understand English - Understands language, and able to report current pain levels and recall events - DEERS-Eligible, Military healthcare beneficiary Exclusion Criteria: - Provider has advised against mild to moderate exercise - Patient unable to sit on the floor for two minutes or unable to stand independently - Complex Regional Pain Syndrome, Fibromyalgia, Chronic Fatigue Syndrome, Auto Immune disease-related pain, other chronic medical conditions (i.e. advanced diabetic neuropathies) that preclude consent - Patients with severe TBI - Practiced Yoga within 6 months - Pre-surgical candidates for back surgery within 3 months - Back surgery within the past year - Pregnancy**; females will be asked to self-report - Undergoing Medical Evaluation Board to determine discharge |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Defense and Veterans Center for Integrative Pain Management |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical Functioning | Physical functioning was assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Functioning subscale (0-100) Total scores are transformed to standardized t scores (mean=50; SD=10). Higher scores indicate higher physical functioning. | Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up | |
Other | Symptom Burden | Symptom burden was assessed using the PROMIS-29 Sleep Disturbance, Pain Interference, Anxiety, Depression, and Fatigue subscales (0-100) Subscales are averaged into a composite score.The Composite scale ranges from 0 to 100, with higher scores indicating higher symptom burden. | Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up | |
Primary | Pain Scores | Participants will choose a pain score using the Defense and Veteran's Pain Rating Scale 2.0 Rate the severity of your CURRENT pain: 0 - No Pain - Hardly notice pain - Notice pain, does not interfere with activities - Sometimes distracts me - Distracts me, can do usual activities - Interrupts some activities - Hard to ignore, avoid usual activities - Focus of attention, prevents doing daily activities - Awful, hard to do anything - Can't bear pain, unable to do anything - As bad as it could be, nothing else matters Higher values represent worse outcomes |
Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up | |
Secondary | Disability | The Roland Morris Disability Questionnaire is reliable at measuring level of disability and is sensitive to change over time for groups of patients with lower back pain. Scale: 0-24 (24 total statements) -Greater levels of disability are reflected by higher numbers on a 24-point scale See link for complete statements: https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0009/76851/roland-morris-low-back-pain-and-disability-questionnaire-rmq1.pdf |
Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up |
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