Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05304286

Conditions

Chronic Post-surgical Pain

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy

Study Details

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

Study ID

NCT05304286

Start date

Apr 7, 2022

Status verified date

Oct, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: ACT Group Intervention

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.

no intervention: Treatment as Usual

Treatment as Usual (TAU) for those with CPSP

Interventions

Acceptance and Commitment Therapy

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

  • Pain acceptance using the Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Christine B Sieberg, PhD

6177261654csieberg@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Christine B Sieberg, PhD

csieberg@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-03.