Musculoskeletal PainPhase 2ATTAC-PAINNCT03315533
Altering The Transition From Acute to Chronic Pain (ATTAC-Pain)
A Phase 2 study testing Duloxetine 30 milligrams (MG) and Duloxetine 60 milligrams (MG) in people with Musculoskeletal Pain, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The current way that pain is treated after trauma and injury is problematic. Most often pain after trauma is treated with opioids (ex. Percocet® or Vicodin®) or anti-inflammatories (ex. ibuprofen). Both of these medications can cause side effects and opioids have been related to the development of addiction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Duloxetine 30 milligrams (MG) and Duloxetine 60 milligrams (MG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 1 Apr 2019
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- generally in good health, are between the ages of 18 and 65, present to the ED with acute (present for <7 days) musculoskeletal pain, and have a current pain score of >4 without a history of pain in the past month.
Who cannot join
- Musculoskeletal pain lasting > 7days
- ED pain score <4
- Chronic pain: Pain present on most days of the week, with an average score >1 in past month, in the same location as presenting pain
- Clinically unstable
- Fracture (except fracture of the phalanges)
- Substantial soft tissue injury†
Show all 31Show fewer
- Hepatic failure (acute or chronic)
- Renal failure (acute or chronic)
- Coronary artery disease, including previous myocardial infarction, Angina, percutaneous transluminal coronary angioplasty, etc.
- History of glaucoma
- Previous congestive heart failure
- History of seizure disorder
- History of mania or psychotic disorder
- History of suicidal ideation
- Prisoner
- History and behavior indicates, in the investigator's judgment, that the participant would likely be noncompliant with the study
- Any other condition that, in the investigator's judgment, would indicate that the patient in unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger patient)
- Does not have a telephone
- Does not have regular internet access and email address
- Unable to speak and read English
- Blood pressure reading(s) in ED that, when considered in the context of patient past and current history, in the investigator's judgment exceeds acceptable level
- Currently taking a monoamine oxidase inhibitor (MAOI)
- Currently taking medication with substantial interaction with duloxetine (Table 1).
- Breastfeeding
- If female, either not postmenopausal (having menses within past year), or, if childbearing potential, positive pregnancy test prior to randomization and not using a medically acceptable form of contraception
- Exceeds acceptable chronic daily opioid use prior to MVC*
- Previously on duloxetine
- Previous allergic reaction to duloxetine
- Antidepressant use within 2 weeks of study start (4 week if Prozac)
- Allergy to lactose
- Intoxicated
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Altering The Transition From Acute to Chronic Pain (ATTAC-Pain): A Randomized Clinical Trial of Duloxetine for the Treatment and Prevention of Musculoskeletal Pain
The current way that pain is treated after trauma and injury is problematic. Most often pain after trauma is treated with opioids (ex. Percocet® or Vicodin®) or anti-inflammatories (ex. ibuprofen). Both of these medications can cause side effects and opioids have been related to the development of addiction. In addition, there are not any treatments that prevent pain from going on to become persistent (last beyond it is supposed to) or chronic (lasting 3 months or longer).
Chronic pain is an enormous problem and there an urgent need to find both alternatives to opioid pain medications and medications that prevent pain from becoming chronic. The ATTAC-Pain (Altering The Transition from Acute to Chronic Pain) study proposes to examine whether duloxetine (a medication that is marketed for depression, anxiety, and specific types of pain conditions), can reduce acute and chronic pain among adults who come to the emergency department (ED)with muscular pain (such as neck pain after a car accident or low back pain). Investigators will enroll 60 patients who come to the ED. Patients will be eligible if they report moderate to severe muscular pain (such as pain in the back, neck, or shoulders). Consenting patients will be randomized to receive duloxetine 30mg, duloxetine 60mg, or placebo (2/3rd chance of being in one of the duloxetine groups). The study team will follow patients for six weeks and collect information on pain outcomes and use of pain medications. Investigators aim to determine if duloxetine can (1) reduce acute pain symptoms following the ED visit, (2) prevent the transition to persistent pain (having pain 6 weeks after the initial ED visit), and (3) decrease opioid use following a motor vehicle collision (MVC). The results of this study will ultimately help determine if duloxetine can be used as a non-opioid pain treatment option that reduces acute pain and prevents the transition to chronic pain. This in turn can improve recovery, reduce opioid use and its consequences, and decrease health care costs.
Read the detailed description
There is an urgent need for new non-opioid pain management options to prevent the development of chronic musculoskeletal pain in patients experiencing acute pain and injury. Investigators propose to address this unmet need by intervening at the point when pain is still acute with pain management that is intended to alter the mechanisms involved in the transition from acute to chronic pain. The proposed study, "Altering The Transition from Acute to Chronic Pain (ATTAC-Pain): A randomized clinical trial of duloxetine for the treatment and prevention of musculoskeletal pain," will examine the ability of duloxetine to improve pain outcomes in individuals presenting to the emergency department (ED) with acute musculoskeletal pain. Investigators will enroll a total of sixty participants. Eligible patients who consent to the study will: be randomized in the ED, receive a dose of study drug (duloxetine 30mg, duloxetine 60mg, or placebo) in the ED, and be discharged from the ED with a two week supply of study drug. Following discharge, the patient will receive follow-up assessments via internet-based surveys and phone to monitor for adverse events and evaluate patient outcomes. The patient will also return to the study site for an in-person follow-up interview 6 weeks after their initial ED visit. The study team will recruit participants at the Rhode Island Hospital and the Miriam Hospital EDs. The results of this study will be used as basis for a potentially high impact large-scale trial examining an important new non-opioid pain treatment option that reduces acute pain and prevents the transition to chronic pain. This in turn can improve recovery, reduce opioid use and its sequelae, and decrease health care costs.
- Conditions
- Musculoskeletal Pain
- Being tested
- Duloxetine 30 milligrams (MG), Duloxetine 60 milligrams (MG), Placebo Oral Tablet
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 30 milligrams (MG)Drug
Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
Duloxetine 60 milligrams (MG)Drug
Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
Placebo Oral TabletDrug
Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine 30 milligrams (mg) | Experimental | Not described Receives: Drug: Duloxetine 30 milligrams (MG) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
| Duloxetine 60 milligrams (mg) | Experimental | Not described Receives: Drug: Duloxetine 60 milligrams (MG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported axial pain (0 - 10 numeric rating scale)
Moderate to severe axial muscoloskeletal pain was chosen as the primary outcome because it is associated with risk for chronic pain development and because it of its clinical relevance. Investigators will asses if there is a decrease in persistent musculoskeletal pain incidence and severity 6 weeks after the ED visit.
Measured: through 6 weeks after enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start19 Jan 2018
- Primary completion25 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayday Fund, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315533
- Sponsor's protocol ID
- RhodeIslandH
- Acronym
- ATTAC-PAIN
- Status last verified
- Dec 2018
- First submitted
- 25 Sep 2017
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beaudoin FL, Gaither R, DeLomba WC, McLean SA. Tolerability and efficacy of duloxetine for the prevention of persistent musculoskeletal pain after trauma and injury: a pilot three-group randomized controlled trial. Pain. 2023 Apr 1;164(4):855-863. doi: 10.1097/j.pain.0000000000002782. Epub 2022 Sep 15.
PubMed 36375173Strauss DH, Santhanam DR, McLean SA, Beaudoin FL. Study protocol for a randomised, double-blind, placebo-controlled clinical trial of duloxetine for the treatment and prevention of musculoskeletal pain: altering the transition from acute to chronic pain (ATTAC pain). BMJ Open. 2019 Mar 5;9(3):e025002. doi: 10.1136/bmjopen-2018-025002.
PubMed 30842115
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering The Transition From Acute to Chronic Pain (ATTAC-Pain): A Randomized Clinical Trial of Duloxetine for the Treatment and Prevention of Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT03315533
- Acronym / sponsor ID
- ATTAC-PAIN / RhodeIslandH
- Conditions
- Musculoskeletal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Mayday Fund, National Institute of General Medical Sciences (NIGMS)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Oct 2017 (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 current way that pain is treated after trauma and injury is problematic. Most often pain after trauma is treated with opioids (ex. Percocet® or Vicodin®) or anti-inflammatories (ex. ibuprofen). Both of these medications can cause side effects and opioids have been related to the development of addiction. In addition, there are not any treatments that prevent pain from going on to become persistent (last beyond it is supposed to) or chronic (lasting 3 months or longer).
Chronic pain is an enormous problem and there an urgent need to find both alternatives to opioid pain medications and medications that prevent pain from becoming chronic. The ATTAC-Pain (Altering The Transition from Acute to Chronic Pain) study proposes to examine whether duloxetine (a medication that is marketed for depression, anxiety, and specific types of pain conditions), can reduce acute and chronic pain among adults who come to the emergency department (ED)with muscular pain (such as neck pain after a car accident or low back pain). Investigators will enroll 60 patients who come to the ED. Patients will be eligible if they report moderate to severe muscular pain (such as pain in the back, neck, or shoulders). Consenting patients will be randomized to receive duloxetine 30mg, duloxetine 60mg, or placebo (2/3rd chance of being in one of the duloxetine groups). The study team will follow patients for six weeks and collect information on pain outcomes and use of pain medications. Investigators aim to determine if duloxetine can (1) reduce acute pain symptoms following the ED visit, (2) prevent the transition to persistent pain (having pain 6 weeks after the initial ED visit), and (3) decrease opioid use following a motor vehicle collision (MVC). The results of this study will ultimately help determine if duloxetine can be used as a non-opioid pain treatment option that reduces acute pain and prevents the transition to chronic pain. This in turn can improve recovery, reduce opioid use and its consequences, and decrease health care costs.
Detailed description
There is an urgent need for new non-opioid pain management options to prevent the development of chronic musculoskeletal pain in patients experiencing acute pain and injury. Investigators propose to address this unmet need by intervening at the point when pain is still acute with pain management that is intended to alter the mechanisms involved in the transition from acute to chronic pain. The proposed study, "Altering The Transition from Acute to Chronic Pain (ATTAC-Pain): A randomized clinical trial of duloxetine for the treatment and prevention of musculoskeletal pain," will examine the ability of duloxetine to improve pain outcomes in individuals presenting to the emergency department (ED) with acute musculoskeletal pain. Investigators will enroll a total of sixty participants. Eligible patients who consent to the study will: be randomized in the ED, receive a dose of study drug (duloxetine 30mg, duloxetine 60mg, or placebo) in the ED, and be discharged from the ED with a two week supply of study drug. Following discharge, the patient will receive follow-up assessments via internet-based surveys and phone to monitor for adverse events and evaluate patient outcomes. The patient will also return to the study site for an in-person follow-up interview 6 weeks after their initial ED visit. The study team will recruit participants at the Rhode Island Hospital and the Miriam Hospital EDs. The results of this study will be used as basis for a potentially high impact large-scale trial examining an important new non-opioid pain treatment option that reduces acute pain and prevents the transition to chronic pain. This in turn can improve recovery, reduce opioid use and its sequelae, and decrease health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duloxetine 30 milligrams (mg) | Experimental | Drug: Duloxetine 30 milligrams (MG) |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet |
| Duloxetine 60 milligrams (mg) | Experimental | Drug: Duloxetine 60 milligrams (MG) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- generally in good health, are between the ages of 18 and 65, present to the ED with acute (present for <7 days) musculoskeletal pain, and have a current pain score of >4 without a history of pain in the past month.
Key exclusion criteria (31 listed)
- Musculoskeletal pain lasting > 7days
- ED pain score <4
- Chronic pain: Pain present on most days of the week, with an average score >1 in past month, in the same location as presenting pain
- Clinically unstable
- Fracture (except fracture of the phalanges)
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 |
|---|---|---|
| Duloxetine 30 milligrams (MG)Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo | Drug | Duloxetine 30 milligrams (mg) |
| Duloxetine 60 milligrams (MG)Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo | Drug | Duloxetine 60 milligrams (mg) |
| Placebo Oral TabletOnce a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo | Drug | Placebo |
Primary outcome
Self-reported axial pain (0 - 10 numeric rating scale)
Time frame: through 6 weeks after enrollment visit
Moderate to severe axial muscoloskeletal pain was chosen as the primary outcome because it is associated with risk for chronic pain development and because it of its clinical relevance. Investigators will asses if there is a decrease in persistent musculoskeletal pain incidence and severity 6 weeks after the ED visit.
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 8 Jul 2020.
- Derived from this study: PubMed 36375173Beaudoin FL, Gaither R, DeLomba WC, McLean SA. Tolerability and efficacy of duloxetine for the prevention of persistent musculoskeletal pain after trauma and injury: a pilot three-group randomized controlled trial. Pain. 2023 Apr 1;164(4):855-863. doi: 10.1097/j.pain.0000000000002782. Epub 2022 Sep 15.
- Derived from this study: PubMed 30842115Strauss DH, Santhanam DR, McLean SA, Beaudoin FL. Study protocol for a randomised, double-blind, placebo-controlled clinical trial of duloxetine for the treatment and prevention of musculoskeletal pain: altering the transition from acute to chronic pain (ATTAC pain). BMJ Open. 2019 Mar 5;9(3):e025002. doi: 10.1136/bmjopen-2018-025002.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Duloxetine 30 milligrams (MG) and Duloxetine 60 milligrams (MG) in people with Musculoskeletal Pain, run by Rhode Island Hospital 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 31 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 8 Jul 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-reported axial pain (0 - 10 numeric rating scale) (time frame: through 6 weeks after enrollment visit). 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 NCT03315533, which also lists 2 linked publications.
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 8 Jul 2020.