Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults
Primary Purpose
Chronic Post-surgical Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Post-surgical Pain
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.
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
ACT Group Intervention
Treatment as Usual
Arm Description
We will evaluate the effects of an Acceptance and Commitment Therapy (ACT) one-day group intervention (with 1-month post group zoom booster session) on the functional near-infrared spectroscopy (fNIRS) signal in groups of adolescents and adult patients diagnosed with CPSP at >3 months post major orthopedic surgery.
Treatment as Usual (TAU) for those with CPSP
Outcomes
Primary Outcome Measures
Pain acceptance using the Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R)
The 20-item CPAQ-revised has been designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Higher scores indicate higher levels of acceptance
Secondary Outcome Measures
Functional brain metrics using fNIRS
To identify alterations in brain metrics and define changes in brain function as a correlate of pain, participants will undergo an fNIRS brain scan. The following regions of interest will be explored: primary somatosensory cortex (SI) and the medial prefrontal cortex (mPFC). fNIRS is a non-invasive neuroimaging method that employs near infrared light to measure cortical hemodynamic changes. The near infrared light penetrates the superficial layers (the skin and the skull) to then reach the cortex. Throughout the travel within the tissue, light is mostly absorbed by chromophores, namely the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR).
Full Information
NCT ID
NCT05304286
First Posted
December 22, 2021
Last Updated
December 7, 2022
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05304286
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post-surgical Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACT Group Intervention
Arm Type
Active Comparator
Arm Description
We will evaluate the effects of an Acceptance and Commitment Therapy (ACT) one-day group intervention (with 1-month post group zoom booster session) on the functional near-infrared spectroscopy (fNIRS) signal in groups of adolescents and adult patients diagnosed with CPSP at >3 months post major orthopedic surgery.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as Usual (TAU) for those with CPSP
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
The aim of ACT is to address avoidance behaviors by increasing openness to difficult experiences, such as pain, and to develop an awareness of behavioral options that will aid to facilitate behavior change processes that are in accord with living a values-based life.
Primary Outcome Measure Information:
Title
Pain acceptance using the Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R)
Description
The 20-item CPAQ-revised has been designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Higher scores indicate higher levels of acceptance
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Functional brain metrics using fNIRS
Description
To identify alterations in brain metrics and define changes in brain function as a correlate of pain, participants will undergo an fNIRS brain scan. The following regions of interest will be explored: primary somatosensory cortex (SI) and the medial prefrontal cortex (mPFC). fNIRS is a non-invasive neuroimaging method that employs near infrared light to measure cortical hemodynamic changes. The near infrared light penetrates the superficial layers (the skin and the skull) to then reach the cortex. Throughout the travel within the tissue, light is mostly absorbed by chromophores, namely the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR).
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine B Sieberg, PhD
Phone
6173552296
Email
christine.sieberg@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Claire E Lunde
Email
claire.lunde@childrens.harvard.edu
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Sieberg, PhD
Email
christine.sieberg@childrens.harvard
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults
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