PainSBIRT LBPNCT02049086

Pain Management for Veterans Filing Compensation Claims

A study testing SBIRT-PM and Pain Module in people with Pain, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This proposal will develop and test an indicated prevention strategy, Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM), in Veterans who have filed a claim for a (military) service-connected injury for which they have requested financial compensation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: SBIRT-PM and Pain Module
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Jan 2018
Phase: Interventional
Are there results?: None posted in the registry

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

Veteran of OEF/OIF/OND
Scheduled exam for back, neck, knee, or shoulder. These four body parts were selected because they are classified as MSD by the VBA and are common causes of chronic non-cancer pain. Including other conditions (e.g. osteomyelitis, muscle injuries) would introduce more heterogeneity in illness course.
Able to participate psychologically and physically, able to provide informed consent, complete assessments, and participate in study procedures.
Self-reports peak pain of at least 2 on a numeric pain rating scale (0 "no pain" to 10 "worst pain imaginable" in the last 28 days in the joint that is the focus of the claim. This broad pain inclusion criterion may be narrowed after the Counseling Refinement Stage. Some Veterans apply for service connection for injuries that are not currently symptomatic, in case the injury recurs. This criterion will exclude these asymptomatic Veterans
Risky substance use within the last 28 days, defined as one of the following:
Risky alcohol use: i.e. >14 drinks/week or>4 drinks/occasion for men 65 or younger; >7 drinks/week or >3 drinks/occasion for women. A standard drink will be 14 grams of absolute alcohol, equivalent to 12 oz of beer, 5 oz of wine, or 1.5 oz of 80-proof liquor
Self-reported use of an illicit drug in the preceding 28 days. Use of opioids or sedative hypnotics not prescribed to the Veteran will be considered illicit drug use.Medical marijuana is legal in Connecticut but is illegal federally. Use of medical marijuana puts someone at some risk for future misuse of cannabis or other drugs and therefore will be treated as an illicit drug.
Misuse of prescribed opioid medications in the preceding 28 days. Two questions adapted from the CIDI for use in a NIDA Clinical Trials Network study, were modified to describe misuse of prescribed opioid medications: "How often have you taken your pain medications in larger amounts than prescribed or for a longer period than prescribed?" and "How often have you used your pain medicines to get high, to relax, or to make you feel more alert?"

Who cannot join

Will not be able to attend the follow-up appointments.
Attended VA or non-VA substance abuse treatment during the three months prior to randomization. Veterans who are receiving mental health treatment but indicate it is not addressing substance use will be enrolled.
Physiological dependence on alcohol, illicit drugs, or non-prescribed opioids. People with more severe dependence have not benefited from SBIRT in prior studies.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, 06516

Other trials in United States

About this study

To finalize the procedures, manual, and training materials of SBIRT-PM. The goals of this stage will be (1) optimizing SBIRT-PM's appeal to Veterans concerned about their musculoskeletal conditions and their Compensation claims; and (2) finalizing the counseling materials and procedures.
To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a pain module only arm.

Conditions: Pain
Being tested: SBIRT-PM, Pain Module
Keywords: SBIRT, Screening, Brief Intervention, Referral to Treatment, Pain-Management, Veterans
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBIRT-PMBehavioural
Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)
Pain ModuleBehavioural
The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)

Study groups in NCT02049086
Study group	Role	What they receive
SBIRT-PM	Experimental	Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM) Receives: Behavioral: SBIRT-PM
Pain Module Only	Active comparator	The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only) Receives: Behavioral: Pain Module
No Additional Referral	No intervention	No intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Risky substance use
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
Measured: baseline
Pain
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
Measured: baseline
Service Use
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
Measured: baseline
Risky substance use
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
Measured: week 4
Risky substance use
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
Measured: week 12
Pain
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
Measured: week 4
Pain
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
Measured: week 12
Service Use
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
Measured: week 4
Service Use
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jan 2018

First posted29 Jan 2014 (estimated)
Study startMar 2014
Primary completionJan 2018
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
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: Screening
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02049086
Sponsor's protocol ID: R34AT008318-01
Other IDs: R34AT008318-01
Acronym: SBIRT LBP
Status last verified: Jun 2018
First submitted: 24 Jan 2014
Last updated: 15 Jun 2018
Results posted: No
Data monitoring committee: No

Publications

Rosen MI, Becker WC, Black AC, Martino S, Edens EL, Kerns RD. Brief Counseling for Veterans with Musculoskeletal Disorder, Risky Substance Use, and Service Connection Claims. Pain Med. 2019 Mar 1;20(3):528-542. doi: 10.1093/pm/pny071.
PubMed 29800338

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain Management for Veterans Filing Compensation Claims
ClinicalTrials.gov ID: NCT02049086
Acronym / sponsor ID: SBIRT LBP / R34AT008318-01
Conditions: Pain
Keywords: SBIRT, Screening, Brief Intervention, Referral to Treatment, Pain-Management, Veterans
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (estimated)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Mar 2014
Primary completion: Jan 2018 (actual)
Study completion: Jan 2018 (actual)
First posted: 29 Jan 2014 (estimated)
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.

To finalize the procedures, manual, and training materials of SBIRT-PM. The goals of this stage will be (1) optimizing SBIRT-PM's appeal to Veterans concerned about their musculoskeletal conditions and their Compensation claims; and (2) finalizing the counseling materials and procedures.
To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a pain module only arm.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SBIRT-PM	Experimental	Behavioral: SBIRT-PMScreening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)
Pain Module Only	Active comparator	Behavioral: Pain ModuleThe pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)
No Additional Referral	No intervention	–No intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Veteran of OEF/OIF/OND
Scheduled exam for back, neck, knee, or shoulder. These four body parts were selected because they are classified as MSD by the VBA and are common causes of chronic non-cancer pain. Including other conditions (e.g. osteomyelitis, muscle injuries) would introduce more heterogeneity in illness course.
Able to participate psychologically and physically, able to provide informed consent, complete assessments, and participate in study procedures.
Self-reports peak pain of at least 2 on a numeric pain rating scale (0 "no pain" to 10 "worst pain imaginable" in the last 28 days in the joint that is the focus of the claim. This broad pain inclusion criterion may be narrowed after the Counseling Refinement Stage. Some Veterans apply for service connection for injuries that are not currently symptomatic, in case the injury recurs. This criterion will exclude these asymptomatic Veterans
Risky substance use within the last 28 days, defined as one of the following:

Key exclusion criteria (3 listed)

Will not be able to attend the follow-up appointments.
Attended VA or non-VA substance abuse treatment during the three months prior to randomization. Veterans who are receiving mental health treatment but indicate it is not addressing substance use will be enrolled.
Physiological dependence on alcohol, illicit drugs, or non-prescribed opioids. People with more severe dependence have not benefited from SBIRT in prior studies.

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
SBIRT-PMScreening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)	Behavioural	SBIRT-PM
Pain ModuleThe pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)	Behavioural	Pain Module Only

Primary outcome

Risky substance use
Time frame: baseline
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
Pain
Time frame: baseline
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
Service Use
Time frame: baseline
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
Risky substance use
Time frame: week 4
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
Risky substance use
Time frame: week 12
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
Pain
Time frame: week 4
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
Pain
Time frame: week 12
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
Service Use
Time frame: week 4
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
Service Use
Time frame: week 12
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
Derived from this study: PubMed 29800338Rosen MI, Becker WC, Black AC, Martino S, Edens EL, Kerns RD. Brief Counseling for Veterans with Musculoskeletal Disorder, Risky Substance Use, and Service Connection Claims. Pain Med. 2019 Mar 1;20(3):528-542. doi: 10.1093/pm/pny071.

Related trials for Pain

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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 SBIRT-PM and Pain Module in people with Pain, run by Yale University 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 8 inclusion and 3 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 15 Jun 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Risky substance use (time frame: baseline). The study lists 9 primary outcomes in all. 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 NCT02049086, 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 15 Jun 2018.