PTSDNCT05700279
Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
A study testing Stellate Ganglion Block and Cognitive Processing Therapy in people with PTSD and Chronic Pain, run by Rush University Medical Center at 1 site in United States.
Trial summary
Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Chronic Pain
- What is being tested?
- Stellate Ganglion Block and Cognitive Processing Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Feb 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews
- Presenting to the Rush ED with acute pain without debilitating trauma
- A primary acute pain site
- Self-reported symptoms consistent with a diagnosis of PTSD
- People with well-controlled diabetes or HIV/AIDS with chronic neuropathic pain will be included if their acute pain complaint at ED presentation is not due to neuropathic pain
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- Individuals with a history of psychotic or bipolar disorder that is currently well managed, have been treated for the condition for at least 3 months, are able to coherently answer interview questions, and are judged by study staff to be capable of participating in study
- Current chronic illness that involves constant or frequent pain if their acute pain complaint at ED presentation is not due to the chronic illness. (case-by-case basis)
- Current chronic pain from various sources if their acute pain complaint at ED presentation is not related to their current chronic pain. (case-by-case basis)
Who cannot join
- Pain intensity great enough to impair concentration or capacity to understand instructions or the nature of being invited into a study as assessed by a member of the medical staff
- Any injury or illness that precludes their ability to understand or follow instructions as assessed by a member of the medical staff
- Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record (case-by-case basis)
- Pain from traumatic event that is the source of their PTSD
- Neurological disorder
- Blood pressure greater than 160/100 mmHg
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- Taking anticoagulants or antiplatelet drugs other than aspirin
- Pregnancy
- Current alcohol or substance dependence
- Anything that precludes interventions from being successful.
- We will exclude people who are being treated for chronic or significant diseases such as rheumatoid disease, current influenza that may manifest temporary flu- related pain, and heart disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
John W Burns, PhD, 312-942-0379, john_burns@rush.edu
About this study
Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.
Read the detailed description
Untreated PTSD appears to be a key risk factor for the transition from acute pain to chronic pain. Thus, reducing PTSD symptoms during an acute pain episode may potentially decrease the likelihood of transitioning to chronic pain. CPT is an evidence-based trauma-focused cognitive behavioral treatment that is hypothesized to reduce PTSD symptoms via reducing negative trauma-related cognitions about oneself, others, and the world. SGB treatment is an injection of a local anesthetic into the stellate ganglion, which is a bundle of nerves located at the base of the neck that is part of the sympathetic nervous system. Previous studies suggest that 1-week massed CPT and SGB treatment can both reduce the severity of PTSD symptoms in short periods of time via two distinct psychological and biological mechanisms.
This 4 year project will test study hypotheses in a sample of 345 individuals with PTSD symptoms who present to the presenting to the Rush University Medical Center ED or Rush's Primary Care and Preventive Medicine group with non-injury based acute pain. Participants will be randomly assigned to receive 1-week massed CPT, 2 SGB treatments, or usual care. All participants will complete identical self-report and/or clinician administered assessments at baseline (prior to randomization) and on study days 1, 7, 14, 21, 28, 56 (approximately 3 months after the initial ED presentation or Presentation to Preventive Medicine), and 112 (approximately 6 months after ED presentation or presentation to Preventive Medicine).
- Conditions
- PTSD, Chronic Pain
- Being tested
- Stellate Ganglion Block, Cognitive Processing Therapy
- Keywords
- PTSD, Chronic Pain, Acute Pain
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
Stellate Ganglion Block (SGB) procedure involves an injection of a local anesthetic (0.5% ropivacaine) around the stellate ganglion (a bundle of nerves located at the base of the neck) to block the transmission of pain signals. The SGB injection is administered by an anesthesiologist.
Cognitive Processing TherapyBehavioural
Cognitive Processing Therapy (CPT) is a form of trauma-based talk therapy that will be conducted by clinical therapists. CPT can help people identify and challenge unhelpful trauma-related beliefs about themselves, others, and the world.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block Treatment | Active comparator | Participants randomly assigned to the Stellate Ganglion Block (SGB) condition will receive 2 SGB treatments separated by 2 weeks. Receives: Procedure: Stellate Ganglion Block |
| Cognitive Processing Therapy | Active comparator | Participants randomly assigned to the Cognitive Processing Therapy (CPT) condition will receive 1-week massed CPT treatment consisting of 10 CPT sessions given within a single 5-day period via telehealth. Receives: Behavioral: Cognitive Processing Therapy |
| Usual Care | No intervention | Participants randomly assigned to the Usual Care condition will not receive any active intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity
Intensity of chronic pain reported by subject. The PROMIS Pain Intensity scale consists of 3 questions with a 5-point response scale ranging from "Had no pain" -to "Very severe. " Participants are asked how intense their pain has been in the past 7 days. Higher scores indicate more intense pain.
Measured: Through study completion, for an average of 6 months
Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms
PCL-5 will be used to measure self-reported PTSD symptoms. The PCL-5 consists of 20 questions that ask how much a given symptom has bothered the participant within a specified time period. Each question has a 5 point response scale ranging from "not at all" (0) to "extremely" (4). Higher scores indicate greater PTSD symptom severity.
Measured: Through study completion, for an average of 6 months
Secondary outcomes (9)
Change in SCID-5 mood and anxiety disorder diagnoses
The Structured Clinical Interview for the DSM-5 (SCID-5) is a semi-structured interview measure for making DSM-5 diagnoses. The SCID-5 will be administered by a trained interviewer for assessment of mood and anxiety disorders.
Measured: Through study completion, for an average of 6 months
Change in AUDIT-C Self-Reported Substance Use
The Alcohol Use Disorder Identification Test (AUDIT-C) is a self-report questionnaire consisting of 12 items that ask participants about the frequency of their alcohol and substance use both generally and within the past 2 weeks (14 calendar days).
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from "Not at all" to "Very much." Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities.
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form)
Degree of depressive symptoms reported by subject. The PROMIS Depression scale consists of 8 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they felt depressive emotions in the past 7 days. Higher scores indicate more depressive emotions.
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)
Amount of physical activity reported by subject. The PROMIS Physical Function scale consists of 10 questions with a 5-point response scale ranging from "Without any difficulty" to "Unable to do." Participants are asked how much their pain affects their physical functioning. Higher scores indicate more inability to perform specific physical activities due to pain.
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form)
Degree of sleep disturbance reported by subject. The PROMIS Sleep Disturbance scale consists of 8 questions with a 5-point response scale ranging from "Not at all" to "Very much." Participants are asked how much in the past 7 days their symptoms interfered with their sleep. Higher scores indicate more sleep disruptions.
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form)
Degree of anxiety symptoms reported by subject. The PROMIS Anxiety scale consists of 7 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they experienced anxiety symptoms in the past 7 days. Higher scores indicate more anxiety symptoms.
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form)
Degree of anger reported by subject. The PROMIS Anger scale consists of 5 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they experienced anger in the past 7 days. Higher scores indicate more frequent anger.
Measured: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles
Satisfaction with social roles reported by subject. The PROMIS Satisfaction with Social Roles scale consists of 7 questions with a 5-point response scale ranging from "Not at all" to "Very Much." Participants are asked how satisfied they have felt with their performance in various social roles in the past 7 days. Higher scores indicate greater satisfaction.
Measured: Through study completion, for an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Sep 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- John W Burns, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700279
- Sponsor's protocol ID
- 21092002
- Status last verified
- Oct 2025
- First submitted
- 17 Jan 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
- ClinicalTrials.gov ID
- NCT05700279
- Acronym / sponsor ID
- 21092002
- Conditions
- PTSD, Chronic Pain
- Keywords
- PTSD, Chronic Pain, Acute Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Jan 2023 (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.
Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.
Detailed description
Untreated PTSD appears to be a key risk factor for the transition from acute pain to chronic pain. Thus, reducing PTSD symptoms during an acute pain episode may potentially decrease the likelihood of transitioning to chronic pain. CPT is an evidence-based trauma-focused cognitive behavioral treatment that is hypothesized to reduce PTSD symptoms via reducing negative trauma-related cognitions about oneself, others, and the world. SGB treatment is an injection of a local anesthetic into the stellate ganglion, which is a bundle of nerves located at the base of the neck that is part of the sympathetic nervous system. Previous studies suggest that 1-week massed CPT and SGB treatment can both reduce the severity of PTSD symptoms in short periods of time via two distinct psychological and biological mechanisms.
This 4 year project will test study hypotheses in a sample of 345 individuals with PTSD symptoms who present to the presenting to the Rush University Medical Center ED or Rush's Primary Care and Preventive Medicine group with non-injury based acute pain. Participants will be randomly assigned to receive 1-week massed CPT, 2 SGB treatments, or usual care. All participants will complete identical self-report and/or clinician administered assessments at baseline (prior to randomization) and on study days 1, 7, 14, 21, 28, 56 (approximately 3 months after the initial ED presentation or Presentation to Preventive Medicine), and 112 (approximately 6 months after ED presentation or presentation to Preventive Medicine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block Treatment | Active comparator | Procedure: Stellate Ganglion BlockParticipants randomly assigned to the Stellate Ganglion Block (SGB) condition will receive 2 SGB treatments separated by 2 weeks. |
| Cognitive Processing Therapy | Active comparator | Behavioral: Cognitive Processing TherapyParticipants randomly assigned to the Cognitive Processing Therapy (CPT) condition will receive 1-week massed CPT treatment consisting of 10 CPT sessions given within a single 5-day period via telehealth. |
| Usual Care | No intervention | –Participants randomly assigned to the Usual Care condition will not receive any active intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 70 years
- Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews
- Presenting to the Rush ED with acute pain without debilitating trauma
- A primary acute pain site
- Self-reported symptoms consistent with a diagnosis of PTSD
Key exclusion criteria (11 listed)
- Pain intensity great enough to impair concentration or capacity to understand instructions or the nature of being invited into a study as assessed by a member of the medical staff
- Any injury or illness that precludes their ability to understand or follow instructions as assessed by a member of the medical staff
- Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record (case-by-case basis)
- Pain from traumatic event that is the source of their PTSD
- Neurological disorder
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 |
|---|---|---|
| Stellate Ganglion BlockStellate Ganglion Block (SGB) procedure involves an injection of a local anesthetic (0.5% ropivacaine) around the stellate ganglion (a bundle of nerves located at the base of the neck) to block the transmission of pain signals. The SGB injection is administered by an anesthesiologist. | Procedure or surgery | Stellate Ganglion Block Treatment |
| Cognitive Processing TherapyCognitive Processing Therapy (CPT) is a form of trauma-based talk therapy that will be conducted by clinical therapists. CPT can help people identify and challenge unhelpful trauma-related beliefs about themselves, others, and the world. | Behavioural | Cognitive Processing Therapy |
Primary outcome
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity
Time frame: Through study completion, for an average of 6 months
Intensity of chronic pain reported by subject. The PROMIS Pain Intensity scale consists of 3 questions with a 5-point response scale ranging from "Had no pain" -to "Very severe. " Participants are asked how intense their pain has been in the past 7 days. Higher scores indicate more intense pain.
Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms
Time frame: Through study completion, for an average of 6 months
PCL-5 will be used to measure self-reported PTSD symptoms. The PCL-5 consists of 20 questions that ask how much a given symptom has bothered the participant within a specified time period. Each question has a 5 point response scale ranging from "not at all" (0) to "extremely" (4). Higher scores indicate greater PTSD symptom severity.
9 secondary outcomes
Change in SCID-5 mood and anxiety disorder diagnoses
Time frame: Through study completion, for an average of 6 months
Change in AUDIT-C Self-Reported Substance Use
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form)
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form)
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form)
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form)
Time frame: Through study completion, for an average of 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles
Time frame: Through study completion, for an average of 6 months
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 20 Oct 2025.
- 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.
John W Burns, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block and Cognitive Processing Therapy in people with PTSD and Chronic Pain, run by Rush University Medical Center 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 20 Oct 2025. 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?
Contact John W Burns, PhD (312-942-0379, john_burns@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (time frame: Through study completion, for an average of 6 months). 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 20 Oct 2025.