Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain

Lower Back Pain Clinical Trial

— RESTORE  

Official title:

Restorative Exercise for Strength Training and Operational Resilience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132910
• Other study ID #: 380491
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 7, 2015

Study information

• Verified date: November 2019
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Other:
• RESTORE Intervention

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Defense and Veterans Center for Integrative Pain Management Website
•   Defense and Veterans Pain Rating Scale