Clinical trial NCT05304286: Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults
Official title: Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Post-surgical Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current project will (1) enhance our understanding of the neurobiology of chronic post-surgical pain (CPSP); (2) provide a metric to follow patients with CPSP in the clinic; (3) provide a metric for those who will chronify; and (4) understand the age-related differences in CPSP. Ultimately, an improved comprehension of mechanisms linked to CPSP will provide finer tools for optimizing the selection of treatments for individual patients. Moreover, data that demonstrates the underlying pathobiological pain mechanism(s) active in CPSP, particularly those non-responsive to current therapies, may be used to validate novel strategies both pharmacological and non-pharmacological.

Detailed description: In this mechanistic clinical trial, participants will be randomized into either a one-day (5 hours) group workshop based on Acceptance and Commitment Therapy (ACT) and a one-month post workshop zoom individual booster session or Treatment as Usual (TAU).

Dr. Sieberg will conduct the groups with assistance from the RA. Dr. Sieberg is a licensed clinical psychologist, who has delivered manualized ACT for chronic pain in her clinical practice. The intervention follows a manual patterned after an existing 1-day ACT intervention for chronic pain and will be adapted to meet the needs of patients with ongoing CPSP. Topics covered in the workshop include: (1) mindfulness of troublesome thoughts, feelings, and physical sensations; (2) willingness to face and accept experiences that cannot be changed; (3) identifying values; and (4) promoting behavior changes that support value-based action.

The goal of the ACT intervention is to increase awareness of thoughts, feelings, and behaviors that exacerbate pain while minimizing avoidance that interferes with engagement in valued action. Participants will also receive an individually tailored 30-minute booster session via zoom one month following the workshop. During the booster session, ACT principles will be reinforced and the participant will work together with Dr. Sieberg to problem-solve and address any difficulties engaging in ACT exercises and practices.

Eligibility criteria: Inclusion Criteria:

--Females and males aged 12 and older who have previously undergone surgery at least 6 months ago and have chronic post surgical pain (3 months after surgery or longer)

Exclusion Criteria:

* Inability to speak sufficient English or another language that can be interpreted orally and for questionnaires with the research team
* Severe cognitive impairment by history (e.g., intellectual disability, severe head injury)
* Patients with significant psychiatric disorders
* Use of illegal hard drugs including MDMA, heroin, methamphetimes, amphetamines, cocaine, ketamine, benzodiazepines, and phencyclidine. Absence of such drugs will be confirmed in a urine drug screen during the visit. If prescription medication includes any of these compounds, that medication is not exclusionary.

Primary outcomes:
measure: Pain acceptance using the Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R)
timeFrame: 5 years
Secondary outcomes:
measure: Functional brain metrics using fNIRS
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christine B. Sieberg
role: PRINCIPAL_INVESTIGATOR
References: