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

NCT02132910 | Completed Results

• 1 other identifier: 380491
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 1. \- Hardly notice pain 2. \- Notice pain, does not interfere with activities 3. \- Sometimes distracts me 4. \- Distracts me, can do usual activities 5. \- Interrupts some activities 6. \- Hard to ignore, avoid usual activities 7. \- Focus of attention, prevents doing daily activities 8. \- Awful, hard to do anything 9. \- Can't bear pain, unable to do anything 10. \- 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 Outcomes (1)

• Disability

  Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

Other Outcomes (2)

• Physical Functioning

  Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

• Symptom Burden

  Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

Study Arms (2)

RESTORE Intervention

EXPERIMENTAL

1. 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. 2. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. 3. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. 4. 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. 5. 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

Control Group 2

NO INTERVENTION

1. 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. 2. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. 3. 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. 4. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.

Interventions

RESTORE Intervention OTHER

RESTORE Intervention

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• 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.

  PMID: 28919191 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chester Buckenmaier
• Organization: DVCIPM

cbuckenmaier@dvcipm.org

301-816-4710

Study Officials

• Chester Buckenmaier, MD

  Defense and Veterans Center for Integrative Pain Management

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: December 1, 2013
• Primary Completion: August 7, 2015
• Study Completion: August 7, 2015
• Last Updated: November 25, 2019
• Results First Posted: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)