Lower Back PainRESTORENCT02132910
Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain
A study testing RESTORE Intervention in people with Lower Back Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- RESTORE Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 7 Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Back surgery within the past year
- Pregnancy**; females will be asked to self-report
- Undergoing Medical Evaluation Board to determine discharge
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Restorative Exercise for Strength Training and Operational Resilience
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
- Being tested
- RESTORE Intervention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTORE InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- - 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
Measured: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up
Secondary outcomes (1)
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
Measured: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startDec 2013
- Primary completion7 Aug 2015
- Study completion7 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chester Buckenmaier, MD, Principal investigator, Defense and Veterans Center for Integrative Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132910
- Sponsor's protocol ID
- 380491
- Acronym
- RESTORE
- Status last verified
- Nov 2019
- First submitted
- 6 May 2014
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
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.
PubMed 28919191
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restorative Exercise for Strength Training and Operational Resilience
- ClinicalTrials.gov ID
- NCT02132910
- Acronym / sponsor ID
- RESTORE / 380491
- Conditions
- Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 7 Aug 2015 (actual)
- Study completion
- 7 Aug 2015 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESTORE Intervention | Experimental | Other: RESTORE Intervention1. 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. |
| 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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESTORE Intervention | Other | RESTORE Intervention |
Primary outcome
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 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
1 secondary outcome
Disability
Time frame: Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28919191Highland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chester Buckenmaier, MD principal investigator
Defense and Veterans Center for Integrative Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTORE Intervention in people with Lower Back Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.