Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults

NCT05304286 | Recruiting

• 1 other identifier: IRB-P000634
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (1)

• Functional brain metrics using fNIRS

  5 years

Study Arms (2)

ACT Group Intervention

ACTIVE COMPARATOR

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.

Behavioral: Acceptance and Commitment Therapy

Treatment as Usual

NO INTERVENTION

Treatment as Usual (TAU) for those with CPSP

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

ACT Group Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christine B. Sieberg

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine B Sieberg, PhD

CONTACT

6177261654; csieberg@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, Department of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: March 31, 2022
• Study Start: April 7, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)