Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset

NCT05700279 | Recruiting

• 1 other identifier: 21092002
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PTSD; Chronic Pain

Keywords

PTSD; Chronic Pain; Acute Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, for an average of 6 months

Secondary Outcomes (9)

• Change in SCID-5 mood and anxiety disorder diagnoses

  Through study completion, for an average of 6 months

• Change in AUDIT-C Self-Reported Substance Use

  Through study completion, for an average of 6 months

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

  Through study completion, for an average of 6 months

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form)

  Through study completion, for an average of 6 months

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)

  Through study completion, for an average of 6 months

Study Arms (3)

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.

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.

Behavioral: Cognitive Processing Therapy

Usual Care

NO INTERVENTION

Participants randomly assigned to the Usual Care condition will not receive any active intervention.

Interventions

Stellate Ganglion Block PROCEDURE

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.

Stellate Ganglion Block Treatment

Cognitive Processing Therapy BEHAVIORAL

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.

Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John W Burns, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John W Burns, PhD

CONTACT

312-942-0379; john_burns@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)