Trial Outcomes & Findings for Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain (NCT NCT02132910)
NCT ID: NCT02132910
Last Updated: 2019-11-25
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up
Results posted on
2019-11-25
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain
Baseline characteristics by cohort
| Measure |
RESTORE Intervention
n=34 Participants
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
|
Control Group 2
n=34 Participants
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.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-upParticipants 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
Outcome measures
| Measure |
Control Group 2
n=34 Participants
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.
|
RESTORE Intervention
n=34 Participants
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
|
|---|---|---|
|
Pain Scores
3 month follow up
|
3.35 units on a scale
Standard Deviation 1.79
|
2.75 units on a scale
Standard Deviation 2.43
|
|
Pain Scores
6 month follow up
|
2.86 units on a scale
Standard Deviation 2.01
|
2.79 units on a scale
Standard Deviation 2.34
|
|
Pain Scores
Baseline
|
4.32 units on a scale
Standard Deviation 1.61
|
4.68 units on a scale
Standard Deviation 1.51
|
|
Pain Scores
Midtreatment
|
3.97 units on a scale
Standard Deviation 1.71
|
2.60 units on a scale
Standard Deviation 1.83
|
|
Pain Scores
Posttreatment
|
3.67 units on a scale
Standard Deviation 1.86
|
2.48 units on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow upThe 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
Outcome measures
| Measure |
Control Group 2
n=34 Participants
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.
|
RESTORE Intervention
n=34 Participants
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
|
|---|---|---|
|
Disability
Baseline
|
8.68 units on a scale
Standard Deviation 4.82
|
9.21 units on a scale
Standard Deviation 4.91
|
|
Disability
3 month follow up
|
7.04 units on a scale
Standard Deviation 4.55
|
4.43 units on a scale
Standard Deviation 4.62
|
|
Disability
Midtreatment
|
8.03 units on a scale
Standard Deviation 5.46
|
5.90 units on a scale
Standard Deviation 4.52
|
|
Disability
Posttreatment
|
6.70 units on a scale
Standard Deviation 4.59
|
4.41 units on a scale
Standard Deviation 4.67
|
|
Disability
6 month follow up
|
6.52 units on a scale
Standard Deviation 5.33
|
3.25 units on a scale
Standard Deviation 3.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow upPhysical 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.
Outcome measures
| Measure |
Control Group 2
n=34 Participants
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.
|
RESTORE Intervention
n=34 Participants
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
|
|---|---|---|
|
Physical Functioning
Posttreatment
|
42.72 units on a scale
Standard Deviation 5.55
|
47.44 units on a scale
Standard Deviation 7.44
|
|
Physical Functioning
Baseline
|
42.03 units on a scale
Standard Deviation 5.29
|
40.67 units on a scale
Standard Deviation 3.71
|
|
Physical Functioning
Midtreatment
|
42.71 units on a scale
Standard Deviation 6.16
|
45.79 units on a scale
Standard Deviation 7.10
|
|
Physical Functioning
3 month follow up
|
43.38 units on a scale
Standard Deviation 4.82
|
47.34 units on a scale
Standard Deviation 7.43
|
|
Physical Functioning
6 month follow up
|
44.06 units on a scale
Standard Deviation 6.66
|
47.05 units on a scale
Standard Deviation 8.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow upSymptom 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.
Outcome measures
| Measure |
Control Group 2
n=34 Participants
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.
|
RESTORE Intervention
n=34 Participants
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
|
|---|---|---|
|
Symptom Burden
Posttreatment
|
52.59 units on a scale
Standard Deviation 5.69
|
49.42 units on a scale
Standard Deviation 7.05
|
|
Symptom Burden
Baseline
|
53.90 units on a scale
Standard Deviation 5.23
|
54.90 units on a scale
Standard Deviation 5.72
|
|
Symptom Burden
Midtreatment
|
53.28 units on a scale
Standard Deviation 4.99
|
51.63 units on a scale
Standard Deviation 6.55
|
|
Symptom Burden
3 month follow up
|
52.04 units on a scale
Standard Deviation 4.65
|
49.04 units on a scale
Standard Deviation 6.81
|
|
Symptom Burden
6 month follow up
|
51.80 units on a scale
Standard Deviation 7.32
|
48.11 units on a scale
Standard Deviation 7.48
|
Adverse Events
RESTORE Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place