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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: ACT Group InterventionActive comparator 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions

Trial outcomes

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

Time frame
5 years

Secondary outcomes

1

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).

Time frame
5 years

Other outcomes

Sponsors and contacts

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