Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture

NCT03196258 | Terminated

• 1 other identifier: SPOC-CBT-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. In order to study this relationship, researchers at McMaster University have developed the Somatic Pre-Occupation and Coping (SPOC) questionnaire, which identifies illness beliefs that may help to predict which patients are at risk for ongoing pain, reduced quality of life, and delays in returning to work and leisure activities after a fracture requiring surgical treatment. Previous research using the SPOC questionnaire suggests the possibility that fracture patients with illness beliefs that put them at risk for developing ongoing pain could be identified early in the treatment process. These patients may benefit from cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT is effective in reducing ongoing pain and improving quality of life in fracture patients who show illness beliefs that may place them at risk for developing ongoing pain.

Conditions

Pain, Postoperative; Fractures, Closed; Fractures, Open

Keywords

fracture; persistent pain; cognitive behavioural therapy; post surgical pain; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• The prevalence of Persistent Post-Surgical Pain at 12 months' post-fracture

  The primary outcomes are 1) PPSP according to the World Health Organization's (WHO) proposed definition, and 2) the prevalence of moderate to severe pain interference over 12 months post-fracture as assessed by an individual item from the Patient-Reported Outcomes Measurement Information System (PROMIS). The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least two months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternative cause.

  12 months post-fracture

Secondary Outcomes (3)

• Short Form 12 (SF-12)

  1 year

• Return to Function questionnaire

  1 year

• PROMIS-Physical Function 28

  1 year

Other Outcomes (3)

• Exploratory outcome 1: Fracture healing complications

  1 year

• Exploratory outcome 2: time to fracture healing

  1 year

• Exploratory outcome 3: opioid use

  1 year

Study Arms (2)

intervention - CBT

EXPERIMENTAL

Participants in this arm will receive 6 weekly one-on-one, 1-hour sessions of Cognitive Behavioural Therapy session (intervention) in addition to receiving standard of care treatment for their fracture(s).

Behavioral: Cognitive behavioural therapy

control

NO INTERVENTION

Participants in the control arm of the study will receive standard of care treatment for their fracture(s) but will not receive any Cognitive Behavioral Therapy.

Interventions

Cognitive behavioural therapy BEHAVIORAL

Participants who are randomized to the CBT intervention are required to start CBT within 8 weeks of their fracture surgery. The CBT intervention will consist of 6 weekly one-on-one, 1-hour sessions that will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses on the SPOC questionnaire. All other aspects of post-operative care will be at the discretion of participant's surgeon

Also known as: CBT

intervention - CBT

Eligibility Criteria

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

You may qualify if:

• Adult men or women aged 18 years and older.
• Acute open or closed fracture(s) of the appendicular skeleton. Patients with multiple fractures may be included.
• Fracture treated operatively with internal fixation.
• Screened for eligibility within 6 weeks of their fracture.
• Cognitive ability and language skills required to participate in the CBT intervention (in the judgement of site research personnel).
• Able to start the CBT within 8 weeks of their fracture surgery.
• Provision of informed consent.
• Screen positive for unhelpful illness beliefs (SPOC scores ≥74), as assessed at 6 weeks' post-surgical fixation.

You may not qualify if:

• Fragility fracture.
• Stress fracture.
• Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture.
• Active psychosis.
• Active suicidality.
• Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the study.
• Already participating in, or planning to start other psychological treatments (including CBT) within the duration of the study (12 months).
• Anticipated problems with the patient attending CBT sessions and/or returning for follow-up.
• Incarceration.
• Other reason to exclude the patient, as specified.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Academic Health Sciences Organization: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Unity Health Toronto: collaborator

Study Sites (1)

St. Joseph Hospital

Hamilton, Ontario, L8N4A6, Canada

Location

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Related Links

• 28\. Hamner J, Dewitt B. The Development of a Preference-based Scoring System for PROMIS (PROPr): A Technical Report v 1.1. \[Internet\] 2017;available from: http://janelhanmer.pitt.edu/documents/technicalreportv1.1.pdf (accessed August 29, 2017).
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MeSH Terms

Conditions

Pain, Postoperative; Fractures, Closed; Fractures, Open; Fractures, Bone

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Eligible participants will be randomized to 1 of 2 groups: 1) CBT intervention or 2) standard of care. Due to the nature of the intervention, it will not be feasible to blind participants, treating surgeons, or CBT therapists to treatment allocation. The data analyst and Steering Committee will be blinded to treatment allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with operatively managed extremity fractures who screen positive for unhelpful illness beliefs (SPOC scores ≥78) 6-weeks post-fracture fixation will be randomized to receive either 6 weekly one-on-one, 1-hour sessions of cognitive behavioral therapy (CBT) or standard of care (control). Outcomes will be assessed at 3 months, 6 months, 9 months, and 12 months' post-fracture

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 22, 2017
• Study Start: October 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

CA (1)