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

Defense and Veterans Center for Integrative Pain Management

Status: Completed

Conditions: Lower Back Pain

Treatments: Other: RESTORE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02132910

380491

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

RESTORE Intervention

Experimental group

Description:

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.

Treatment:

Other: RESTORE Intervention

Control Group 2

No Intervention group

Description:

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.