Low Back PainRESOLVENCT04494490
Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial
A study testing Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback in people with Low Back Pain, run by Sara Gorczynski at 1 site in United States.
Trial summary
The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,039 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 14 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving physical therapy care for low back pain in an outpatient physical therapy setting
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.
Read the detailed description
Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT practice patterns and utilization of ineffective interventions lower the quality and increase the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education/audit/feedback model for reducing pain, disability, medication use and cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include 3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge study design. An education/audit/feedback model will be used to encourage the physical therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability and pain intensity will be measured with the Oswestry Disability Index and the Defense and Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based on intention to treat principles and will use linear mixed models to compare treatment conditions, and examine the interactions between treatment and sub-grouping status. The RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA healthcare systems.
- Conditions
- Low Back Pain
- Being tested
- Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback
- 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.
Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedbackBehavioural
The aim of the active training strategy is to improve the knowledge and skills of physical therapists with regard to evidence-based physical therapy with an emphasis on active treatments and PIPT for the treatment of patients with low back pain and to encourage increased adherence with CPGs. This Continuing Education (CE) training session will be offered to all therapists regardless of study participation. During the CE training session, focus will be placed on interventions that have been shown to be effective, such as interactive education and discussion, feedback, and reminders.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Condition | No intervention | During the usual care condition the therapists will be instructed "to act as usual," that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines. |
| CPG+PIPT Condition | Active comparator | An active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes Receives: Behavioral: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Change in Defense and Veterans Pain Rating Scale (DVPRS) score
Measured: Every two weeks over course of PT treatment, up to 12 weeks
Disability
Change in Oswestry Disability Index (ODI)
Measured: Every two weeks over course of PT treatment, up to 12 weeks
Secondary outcomes (4)
Healthcare Utilization
Change in frequency of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).
Measured: One year
Healthcare Utilization
Change in extent of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).
Measured: One year
Analgesic Medication Use
Change in frequency of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).
Measured: One year
Analgesic Medication Use
Change in extent of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 May 2021
- Primary completion30 Sep 2023
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Gorczynski
- Sponsor type
- US federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center, University of Pittsburgh, Naval Health Research Center, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, Marine Corps Base Camp Pendleton
- Responsible party
- Sponsor-investigator, Sara Gorczynski, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494490
- Sponsor's protocol ID
- NMCSD.2018.0034
- Acronym
- RESOLVE
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2020
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT04494490
- Acronym / sponsor ID
- RESOLVE / NMCSD.2018.0034
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,039 participants (actual)
- Lead sponsor
- Sara GorczynskiUS federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center, University of Pittsburgh, Naval Health Research Center, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, Marine Corps Base Camp Pendleton
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.
Detailed description
Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT practice patterns and utilization of ineffective interventions lower the quality and increase the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education/audit/feedback model for reducing pain, disability, medication use and cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include 3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge study design. An education/audit/feedback model will be used to encourage the physical therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability and pain intensity will be measured with the Oswestry Disability Index and the Defense and Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based on intention to treat principles and will use linear mixed models to compare treatment conditions, and examine the interactions between treatment and sub-grouping status. The RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA healthcare systems.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Condition | No intervention | –During the usual care condition the therapists will be instructed "to act as usual," that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines. |
| CPG+PIPT Condition | Active comparator | Behavioral: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedbackAn active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving physical therapy care for low back pain in an outpatient physical therapy setting
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedbackThe aim of the active training strategy is to improve the knowledge and skills of physical therapists with regard to evidence-based physical therapy with an emphasis on active treatments and PIPT for the treatment of patients with low back pain and to encourage increased adherence with CPGs. This Continuing Education (CE) training session will be offered to all therapists regardless of study participation. During the CE training session, focus will be placed on interventions that have been shown to be effective, such as interactive education and discussion, feedback, and reminders. | Behavioural | CPG+PIPT Condition |
Primary outcome
Pain Intensity
Time frame: Every two weeks over course of PT treatment, up to 12 weeks
Change in Defense and Veterans Pain Rating Scale (DVPRS) score
Disability
Time frame: Every two weeks over course of PT treatment, up to 12 weeks
Change in Oswestry Disability Index (ODI)
4 secondary outcomes
Healthcare Utilization
Time frame: One year
Healthcare Utilization
Time frame: One year
Analgesic Medication Use
Time frame: One year
Analgesic Medication Use
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback in people with Low Back Pain, run by Sara Gorczynski 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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Intensity (time frame: Every two weeks over course of PT treatment, up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.