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

Restorative Exercise for Strength Training and Operational Resilience

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.

Study Overview

• Status: Completed
• Conditions: Lower Back Pain
• Intervention / Treatment: Other: RESTORE Intervention

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RESTORE Intervention; First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use.; For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor.; For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor.; At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.; At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.	Other: RESTORE Intervention
No Intervention: Control Group 2; First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use.; You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level.; At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use.; At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Investigators: Principal Investigator: Chester Buckenmaier, MD, Defense and Veterans Center for Integrative Pain Management

Publications and helpful links

General Publications

• Highland KB, Schoomaker A, Rojas W, Suen J, Ahmed A, Zhang Z, Carlin SF, Calilung CE, Kent M, McDonough C, Buckenmaier CC 3rd. Benefits of the Restorative Exercise and Strength Training for Operational Resilience and Excellence Yoga Program for Chronic Low Back Pain in Service Members: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jan;99(1):91-98. doi: 10.1016/j.apmr.2017.08.473. Epub 2017 Sep 14. Erratum In: Arch Phys Med Rehabil. 2018 Apr;99(4):777.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 7, 2015
• Study Completion (Actual): August 7, 2015

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 380491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO