Lower Back Pain
Conditions
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.
Interventions
OTHERRESTORE Intervention
Sponsors
Defense and Veterans Center for Integrative Pain Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Functioning | 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. |
| Symptom Burden | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RESTORE 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 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.
RESTORE Intervention | 34 |
| Control Group 2 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. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | RESTORE Intervention | Control Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 33 Participants | 65 Participants |
| Region of Enrollment United States | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
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 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
Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group 2 | Pain Scores | 6 month follow up | 2.86 units on a scale | Standard Deviation 2.01 |
| Control Group 2 | Pain Scores | Baseline | 4.32 units on a scale | Standard Deviation 1.61 |
| Control Group 2 | Pain Scores | Midtreatment | 3.97 units on a scale | Standard Deviation 1.71 |
| Control Group 2 | Pain Scores | Posttreatment | 3.67 units on a scale | Standard Deviation 1.86 |
| Control Group 2 | Pain Scores | 3 month follow up | 3.35 units on a scale | Standard Deviation 1.79 |
| RESTORE Intervention | Pain Scores | 3 month follow up | 2.75 units on a scale | Standard Deviation 2.43 |
| RESTORE Intervention | Pain Scores | Posttreatment | 2.48 units on a scale | Standard Deviation 2.34 |
| RESTORE Intervention | Pain Scores | Baseline | 4.68 units on a scale | Standard Deviation 1.51 |
| RESTORE Intervention | Pain Scores | 6 month follow up | 2.79 units on a scale | Standard Deviation 2.34 |
| RESTORE Intervention | Pain Scores | Midtreatment | 2.60 units on a scale | Standard Deviation 1.83 |
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
Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group 2 | Disability | Midtreatment | 8.03 units on a scale | Standard Deviation 5.46 |
| Control Group 2 | Disability | 3 month follow up | 7.04 units on a scale | Standard Deviation 4.55 |
| Control Group 2 | Disability | Posttreatment | 6.70 units on a scale | Standard Deviation 4.59 |
| Control Group 2 | Disability | 6 month follow up | 6.52 units on a scale | Standard Deviation 5.33 |
| Control Group 2 | Disability | Baseline | 8.68 units on a scale | Standard Deviation 4.82 |
| RESTORE Intervention | Disability | 6 month follow up | 3.25 units on a scale | Standard Deviation 3.15 |
| RESTORE Intervention | Disability | Baseline | 9.21 units on a scale | Standard Deviation 4.91 |
| RESTORE Intervention | Disability | Midtreatment | 5.90 units on a scale | Standard Deviation 4.52 |
| RESTORE Intervention | Disability | Posttreatment | 4.41 units on a scale | Standard Deviation 4.67 |
| RESTORE Intervention | Disability | 3 month follow up | 4.43 units on a scale | Standard Deviation 4.62 |
Other Pre-specified
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.
Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group 2 | Physical Functioning | Midtreatment | 42.71 units on a scale | Standard Deviation 6.16 |
| Control Group 2 | Physical Functioning | 3 month follow up | 43.38 units on a scale | Standard Deviation 4.82 |
| Control Group 2 | Physical Functioning | Posttreatment | 42.72 units on a scale | Standard Deviation 5.55 |
| Control Group 2 | Physical Functioning | 6 month follow up | 44.06 units on a scale | Standard Deviation 6.66 |
| Control Group 2 | Physical Functioning | Baseline | 42.03 units on a scale | Standard Deviation 5.29 |
| RESTORE Intervention | Physical Functioning | 6 month follow up | 47.05 units on a scale | Standard Deviation 8 |
| RESTORE Intervention | Physical Functioning | Baseline | 40.67 units on a scale | Standard Deviation 3.71 |
| RESTORE Intervention | Physical Functioning | Midtreatment | 45.79 units on a scale | Standard Deviation 7.1 |
| RESTORE Intervention | Physical Functioning | Posttreatment | 47.44 units on a scale | Standard Deviation 7.44 |
| RESTORE Intervention | Physical Functioning | 3 month follow up | 47.34 units on a scale | Standard Deviation 7.43 |
Other Pre-specified
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.
Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group 2 | Symptom Burden | Midtreatment | 53.28 units on a scale | Standard Deviation 4.99 |
| Control Group 2 | Symptom Burden | 3 month follow up | 52.04 units on a scale | Standard Deviation 4.65 |
| Control Group 2 | Symptom Burden | Posttreatment | 52.59 units on a scale | Standard Deviation 5.69 |
| Control Group 2 | Symptom Burden | 6 month follow up | 51.80 units on a scale | Standard Deviation 7.32 |
| Control Group 2 | Symptom Burden | Baseline | 53.90 units on a scale | Standard Deviation 5.23 |
| RESTORE Intervention | Symptom Burden | 6 month follow up | 48.11 units on a scale | Standard Deviation 7.48 |
| RESTORE Intervention | Symptom Burden | Baseline | 54.90 units on a scale | Standard Deviation 5.72 |
| RESTORE Intervention | Symptom Burden | Midtreatment | 51.63 units on a scale | Standard Deviation 6.55 |
| RESTORE Intervention | Symptom Burden | Posttreatment | 49.42 units on a scale | Standard Deviation 7.05 |
| RESTORE Intervention | Symptom Burden | 3 month follow up | 49.04 units on a scale | Standard Deviation 6.81 |