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Completed

NCT Number: NCT02132910

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

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.

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Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RESTORE Intervention

Other

Primary outcomes

  1. Pain Scores

    Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up

    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

Secondary outcomes

  1. Disability

    Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

    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

Other outcomes

  1. Physical Functioning

    Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

    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.

  2. Symptom Burden

    Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

    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.

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

Restorative Exercise for Strength Training and Operational Resilience

Acronym: RESTORE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 7, 2014
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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