Condition category
Signs and Symptoms
Date applied
13/11/2015
Date assigned
08/12/2015
Last edited
08/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Orthopaedic injuries (that is injuries to muscles or bones) including extremity trauma (ET) (for example, injuries to the hands or feet) affects the majority of people who have been injured.
More have half of all ET patients report that they are suffering from moderate to severe pain when they are discharged from hospital. The pain goes on to become chronic (long-term) in 86% of cases.
People with chronic pain have a reduced quality of life when compared to patients suffering from common chronic diseases, making chronic pain the most frequent reason for seeking medical attention. Up to 60% of active people who live with chronic pain, including those with ET, find that their pain interferes with their day-to-day living, eventually losing their job or seeing their professional responsibilities decrease. Consequently, chronic pain is associated to a high socio-economic burden in terms of healthcare costs and lost productivity. Considering the impact of chronic pain, the Institute of Medicine of the National Academies Academies recently made “pain prevention” the highest priority for pain relief. The development of chronic pain is thought to be associated with a combination of biological, psychological and social risk factors (otherwise referred to as biopsychosocial risk factors) and protective factors. Severe acute pain and lower extremity (e.g. feet) injuries have been the sole biologically related risk factors of chronic pain repeatedly seen in ET patients. Several psychological risk factors also seem to be involved, more precisely pain catastrophizing (viewing it as worse than it actually is), pain-related fear, anxiety and depression. Moreover, pain self-efficacy (SE) (that is, a person’s belief that they can manage their pain) and pain acceptance have been identified to help protect against chronic pain. Research suggests that cognitive-behavioral interventions (treatments) have been the most successful way of addressing psychological factors in people suffering from chronic pain. These interventions focus on helping people with pain to realize that they can, in fact, manage their pain, and provide them with skills to respond in a more adaptive way. There is evidence to suggest that cognitive-behavioral interventions could prevent acute pain from developing into chronic pain several months after an injury. However, no such interventions have yet been developed nor tested in ET patients. Accordingly, a cognitive-behavioral intervention given to patients in acute pain after a recent trauma injury could help prevent it from becoming chronic pain. The aims of this study are to see whether such an intervention is appropriate, suitable and convenient and then see if it works at reducing the amount of pain a patient experiences and also its effects on daily life 6 months after the injury has occurred.

Who can participate?
Adults (aged at least 18) at risk of developing chronic pain after ET.

What does the study involve?
The study is split into two phases. In the first phase, clinicians and patients evaluate a preliminary (first) version of the intervention to allow researchers to determine how acceptable it is. This version consists of six 30-45 minute sessions (four regular and two booster) first taking place in the hospital and then continuing once the patient has been discharged from hospital for up to three months after the injury occurs. In the second phase, participants are randomly allocated into one of two groups. Those in group 1 (experimental) receive both the intervention and their usual pain management treatment. The intervention involves 4 regular sessions of treatment and 2 booster sessions lasting between 30-45 minutes. The first session starts 48 hours after admission to hospital or 24 hours after surgery. The last (booster) session occurs 3 months after the injury. Those in group 2 (control) receive their usual pain management treatments only.

What are the possible benefits and risks of participating?
Patients who participate in this study could experience less acute pain and the treatment may help prevent the pain becoming chronic pain. However,considering it is not yet known how well the treatment will perform, this cannot be confirmed. Possible risks include stress, anxiety or worsening of pain caused by activities of the intervention.

Where is the study run from?
Sacred Heart Hospital of Montréal (Hôpital du Sacré-Coeur de Montréal)

When is the study starting and how long is it expected to run for?
November 2015 to March 2018

Who is funding the study?
1. Canadian Institutes of Health Research
2. Quebec Research Funds in Health (Canada)
3. Quebec Nursing Intervention Research Network (Canada)

Who is the main contact?
Ms Melanie Berube
melanie.berube2@mail.mcgill.ca

Trial website

Contact information

Type

Scientific

Primary contact

Ms Melanie Berube

ORCID ID

http://orcid.org/0000-0002-6657-3915

Contact details

Sacred Heart Hospital of Montréal
5400 Boulevard Gouin Ouest
Montreal
H4J 1C5
Canada
1 (514) 338-2222 extension 7366
melanie.berube2@mail.mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Development and pilot randomized controlled trial of a cognitive-behavioral intervention to prevent acute to chronic pain transition in extremity trauma patients

Acronym

Study hypothesis

Research questions:
1. Is the preliminary version of the preventive cognitive-behavioral intervention acceptable from the perspective of clinicians and ET patients in terms of its effectiveness, appropriateness, suitability and convenience ?
2. Is the preventive cognitive-behavioral intervention feasible?
3. Are the research methods feasible?
4. What is the difference in pain intensity and pain interference with daily living activities between the intervention and control groups at 6 months post-injury?
5. What is the difference in pain SE, pain acceptance, pain catastrophizing, pain-related fear, anxiety, depression and healthcare service utilization at 6 months post-injury?
6. Does the refined intervention remain acceptable to ET patients?

Hypotheses:
1- The experimental group will experience less pain intensity and pain interference with daily living activities (primary outcomes) compared to the control group at 6 months post-injury
2- The experimental group will present increase pain SE and pain acceptance as well as a reduction in pain catastrophizing, pain-related fear, anxiety, depression and healthcare service utilization (secondary outcomes) in contrast to the control group at 6 months post-injury

Ethics approval

The ethics committee of research and evaluation of health technologies (HSCM), 23/11/2015, ref: 2016-1226

Study design

Phase I: A formal evaluation of the intervention acceptability by clinicians and patients
Phase II: A 2-arm, single-blind, pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Acute to chronic pain transition in extremity trauma patients

Intervention

1. The experimental group: Participants will receive a preventive cognitive-behavioral intervention comprising 4 regular sessions and 2 booster sessions of 30 to 45 minutes and usual care (i.e., analgesics and physiotherapy). The first session will be initiated 48 hours after hospital admission or 24 hours in postoperative phase. The last booster session will be provided at 3 months post-injury
2. Control group: Participants will receive usual care defined as analgesics and physiotherapy

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Pain intensity and pain interference with daily activities measured by the modified Brief Pain Inventory at baseline (48 hours after hospital admission or 24 hours in postoperative phase), 3 months (at intervention end) and at 6 months.

Secondary outcome measures

1. Pain Self-Efficacy measured by the Pain Self-Efficacy Questionnaire
2. Pain Acceptance measured by the Chronic Pain Acceptance Questionnaire-8 items
3. Pain Catastrophizing measured by the Pain Catastrophizing Scale
4. Pain-Related Fear measured by the Tampa Scale for Kinesiophobia
5. Anxiety and Depression measured by the Hospital Anxiety and Depression Scale
6. Health Status measured by the SF-12v2
7. Patients overall evaluation with different aspects of their responses to treatment, including:
7.1. Pain relief
7.2. Improvement in functioning
7.3. Quality of life
7.4. Global condition measured Patient Global Impression of Change

These outcomes will be measured at baseline (48 hours after hospital admission or 24 hours in postoperative phase), 3 months (at intervention end) and at 6 months.

Overall trial start date

05/11/2015

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years of age or older
2. Able to read and speak French
3. Have a lower ET
4. At risk of developing chronic pain

Although several chronic pain risk factors have been identified in ET patients, no screening tool is readily available. Since acute pain intensity has been the sole chronic pain risk factor consistently found in this population and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendation to consider such inclusion criterion , a decision was made to consider this factor when screening patients at risk of developing chronic pain. Hence, patients who will present pain intensity > 4/10 at least once a day upon movement in the first 48 hours post-injury, which corresponds to moderate to severe pain intensity, will be enrolled. This criterion is based on the experience of the investigator who has witnessed high pain intensities in such specific time periods.Considering that lower extremity injury has been identified as a chronic pain risk factor and the need to optimize sample homogeneity, only patients with such injuries will be recruited.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Unable to understand French
2. Spinal cord injury
3. Other trauma associated with high-intensity pain [> two ribs fracture or surgical abdominal trauma
4. Transfer to a regional hospital (14% of ET patients are returned to their referral hospital)
5. Cognitive impairment [i.e., dementia, moderate-severe traumatic brain injury – Glasgow coma scale score < 13/15 limiting the capacity to participate to the intervention and to complete questionnaires
6. Hospitalized in the intensive care unit (ICU)
7. Need for more than 7 days of hospitalization in the ICU

Recruitment start date

01/05/2016

Recruitment end date

01/05/2017

Locations

Countries of recruitment

Canada

Trial participating centre

Sacred Heart Hospital of Montréal (Hôpital du Sacré-Coeur de Montréal)
5400 Boulevard Gouin Ouest
Montreal
H4J 1C5
Canada

Sponsor information

Organisation

McGill University - Ingram School of Nursing

Sponsor details

Wilson Hall
3506 University Street
Montreal
H3A 2A7
Canada

Sponsor type

University/education

Website

http://www.mcgill.ca/nursing/

Organisation

Sacred Heart Hospital of Montréal (Hôpital du Sacré-Coeur de Montréal)

Sponsor details

5400 Boulevard Gouin Ouest
Montreal
H4J 1C5
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.crhscm.ca/

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Quebec Research Funds in Health (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Quebec Nursing Intervention Research Network (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The following publications are planned:
1. Study protocol (Feasibility and pilot studies journal)
2. Intervention development and acceptability assessment (Nursing Research journal)
3. Feasibility and pilot RCT findings (Clinical Journal of Pain, Pain or Journal of Trauma)

Intention to publish date

15/01/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes