AzTrials
AzTrials

Pain, PostoperativeSPOC_CBTNCT03196258

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

A study testing Cognitive behavioural therapy in people with Pain, Postoperative and Fractures, Closed, run by McMaster University at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive behavioural therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteCanada
Study dates
1 Oct 2018to 1 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The inclusion criteria are:

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

The exclusion criteria are:

  1. Fragility fracture.
  2. Stress fracture.
  3. 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.
  4. Active psychosis.
  5. Active suicidality.
  6. 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.
  7. Already participating in, or planning to start other psychological treatments (including CBT) within the duration of the study (12 months).
  8. Anticipated problems with the patient attending CBT sessions and/or returning for follow-up.
  9. Incarceration.
  10. Other reason to exclude the patient, as specified.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph Hospital

    Hamilton, Ontario, L8N4A6

Other trials in Canada

About this study

Official title: Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures: A Randomized Controlled Trial (SPOC-CBT)

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.

Read the detailed description

In North America, chronic non-cancer pain affects approximately 30% of the population, with similar rates in Europe and Australia. Surgery and trauma are frequently cited as triggering events responsible for the development of chronic pain. A survey of 5,130 patients attending 10 outpatient clinics located throughout North Britain found that 41% attributed their chronic pain to a traumatic event or surgery. The presence of persistent pain can have a major impact on patients' quality of life, including their ability to return to work and their daily activities.

The relationship between psychological factors, behaviors, and cognitive processes and the sensation of pain is well documented. Stress, distress, anxiety, depression, catastrophizing, fear-avoidance behaviors, and poor coping strategies appear to have a significant positive relationship with both acute and chronic pain. Evidence suggests that these psychological factors can cause alterations along the spinal and supraspinal pain pathways which influence the perception of pain. Previous studies suggest that patients' beliefs and expectations may be associated with clinical outcomes, including self-reported pain.

Clinical outcomes following operatively managed fractures of the extremities are variable and many patients continue to experience persistent pain and disability one-year after surgery and beyond. In a recent trial involving patients with open extremity fractures, 65% of patients reported moderate to very severe pain and 35% reported moderate to extreme pain interference at one-year. A systematic review of 20 observational studies of traumatic tibial fracture repairs found the mean incidence of persistent post-surgical pain (PPSP) was 47.4% (range: 10% to 86%) at an average of 23.9 months after surgery. Although several risk factors for PPSP have been identified, many, such as younger age and female gender, are non-modifiable and thus not amendable to direct intervention.

The effect of patients' beliefs and expectations on their recovery following traumatic injuries is an under-investigated area. In response to this gap, Busse et al. developed and evaluated the Somatic Pre-Occupation and Coping (SPOC) questionnaire to identify unhelpful illness beliefs that are predictive of poorer functional outcomes post-fracture. This self-administered questionnaire identified unhelpful illness beliefs among approximately one third of patients with operatively managed extremity fractures. Furthermore, high somatic pre-occupation and poor coping at 6-weeks post-fracture (as measured by the SPOC questionnaire) were found to be strongly associated with PPSP, functional limitations, unemployment, and reduced quality of life 1 year after fracture fixation. This suggests the possibility that fracture patients who exhibit unhelpful illness beliefs can be identified and targeted for concurrent therapy designed to modify such cognitions and improve prognosis. At present, however, there are no approaches that have been shown effective for improving recovery among high-risk patients.

The findings from the FLOW trial highlight the importance of patient beliefs in recovery from orthopaedic trauma. A number of systematic reviews have shown patients' perceptions regarding their illness experience can be modified, and that such efforts can improve outcomes. Moss-Morris and colleagues explored the effect of CBT among patients attending a multidisciplinary chronic pain clinic and found that changes in cognitive processes accounted for 26% of the variation in improved health-related quality of life scores. Collectively, these findings suggest that targeting and modifying unhelpful beliefs through CBT may provide an effective strategy to improve outcomes among high-risk trauma patients.

Being tested
Cognitive behavioural therapy
Keywords
fracture, persistent pain, cognitive behavioural therapy, post surgical pain, health-related quality of life
Medical subject headings
Pain, Postoperative, Fractures, Closed, Fractures, Open, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioural therapyBehavioural

    Also called CBT

    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

Study groups in NCT03196258
Study groupRoleWhat they receive
intervention - CBTExperimentalParticipants 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).
Receives: Behavioral: Cognitive behavioural therapy
controlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months post-fracture

Secondary outcomes (3)

  1. Short Form 12 (SF-12)

    General health related quality of life will be assessed by the SF-12. The SF-12 is an established, reliable and validated health status measure.It is a self-administered, 12-item questionnaire that measures health-related quality of life in 8 domains related to physical, social, mental, and emotional functioning, bodily pain, and general health. Both physical and mental summary scores can be obtained. Each domain is scored separately from 0 (lowest level) to 100 (highest level).

    Measured: 1 year

  2. Return to Function questionnaire

    Return to function will be measured by when participants' return to work, household activities, and leisure activities, as well as when they achieve 80% of their pre-injury function. The return to function outcome will be assessed using the Return to Function questionnaire.

    Measured: 1 year

  3. PROMIS-Physical Function 28

    HRQL will also be assessed by the PROMIS-PF28, as recent research suggests it may be more sensitive to change than the SF-12. The PROMIS-PF is a standard for patient-reported outcomes research and practice and recommended for initial outcome assessment. Studies continue to support its construct validity and feasibility. The PROMIS-PF includes seven HRQoL domains: Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain. The PROMIS-Physical Function 28 will be used to assess seven health quality of life domains.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2017
  2. Study start1 Oct 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Dec 2019

Why it stopped: Feasibility issues with the study treatment (in-person CBT) resulted in the study ending earlier than anticipated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03196258
Sponsor's protocol ID
SPOC-CBT-001
Acronym
SPOC_CBT
Status last verified
Feb 2020
First submitted
13 Jun 2017
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Moulin DE, Clark AJ, Speechley M, Morley-Forster PK. Chronic pain in Canada--prevalence, treatment, impact and the role of opioid analgesia. Pain Res Manag. 2002 Winter;7(4):179-84. doi: 10.1155/2002/323085.

    PubMed 12518174

  • Johannes CB, Le TK, Zhou X, Johnston JA, Dworkin RH. The prevalence of chronic pain in United States adults: results of an Internet-based survey. J Pain. 2010 Nov;11(11):1230-9. doi: 10.1016/j.jpain.2010.07.002. Epub 2010 Aug 25.

    PubMed 20797916

  • Blyth FM, March LM, Brnabic AJ, Jorm LR, Williamson M, Cousins MJ. Chronic pain in Australia: a prevalence study. Pain. 2001 Jan;89(2-3):127-34. doi: 10.1016/s0304-3959(00)00355-9.

    PubMed 11166468

  • Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.

    PubMed 16095934

  • Elliott AM, Smith BH, Penny KI, Smith WC, Chambers WA. The epidemiology of chronic pain in the community. Lancet. 1999 Oct 9;354(9186):1248-52. doi: 10.1016/s0140-6736(99)03057-3.

    PubMed 10520633

  • Crombie IK, Davies HT, Macrae WA. Cut and thrust: antecedent surgery and trauma among patients attending a chronic pain clinic. Pain. 1998 May;76(1-2):167-71.

    PubMed 9696470

  • Linton SJ. A review of psychological risk factors in back and neck pain. Spine (Phila Pa 1976). 2000 May 1;25(9):1148-56. doi: 10.1097/00007632-200005010-00017.

    PubMed 10788861

  • Wiech K, Tracey I. The influence of negative emotions on pain: behavioral effects and neural mechanisms. Neuroimage. 2009 Sep;47(3):987-94. doi: 10.1016/j.neuroimage.2009.05.059. Epub 2009 May 28.

    PubMed 19481610

  • Mondloch MV, Cole DC, Frank JW. Does how you do depend on how you think you'll do? A systematic review of the evidence for a relation between patients' recovery expectations and health outcomes. CMAJ. 2001 Jul 24;165(2):174-9.

    PubMed 11501456

  • Ebrahim S, Malachowski C, Kamal El Din M, Mulla SM, Montoya L, Bance S, Busse JW. Measures of patients' expectations about recovery: a systematic review. J Occup Rehabil. 2015 Mar;25(1):240-55. doi: 10.1007/s10926-014-9535-4.

    PubMed 25100443

  • Sprague S, Leece P, Bhandari M, Tornetta P 3rd, Schemitsch E, Swiontkowski MF; S.P.R.I.N.T. Investigators. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials. 2003 Dec;24(6):719-25. doi: 10.1016/j.cct.2003.08.012.

    PubMed 14662277

  • Montes A, Roca G, Sabate S, Lao JI, Navarro A, Cantillo J, Canet J; GENDOLCAT Study Group. Genetic and Clinical Factors Associated with Chronic Postsurgical Pain after Hernia Repair, Hysterectomy, and Thoracotomy: A Two-year Multicenter Cohort Study. Anesthesiology. 2015 May;122(5):1123-41. doi: 10.1097/ALN.0000000000000611.

    PubMed 25985024

  • Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.

    PubMed 11020770

  • Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Kulkarni AV, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators & the Medically Unexplained Syndromes Study Group. Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. J Orthop Trauma. 2012 Jun;26(6):370-8. doi: 10.1097/BOT.0b013e31822421e2.

    PubMed 22011635

  • Reininga IH, Brouwer S, Dijkstra A, Busse JW, Ebrahim S, Wendt KW, El Moumni M. Measuring illness beliefs in patients with lower extremity injuries: reliability and validity of the Dutch version of the Somatic Pre-Occupation and Coping questionnaire (SPOC-NL). Injury. 2015 Feb;46(2):308-14. doi: 10.1016/j.injury.2014.08.042. Epub 2014 Sep 16.

    PubMed 25441575

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive behavioural therapy in people with Pain, Postoperative and Fractures, Closed, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Feasibility issues with the study treatment (in-person CBT) resulted in the study ending earlier than anticipated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of Persistent Post-Surgical Pain at 12 months' post-fracture (time frame: 12 months post-fracture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03196258, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in