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Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan (PainsCan)

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ClinicalTrials.gov Identifier: NCT03981809
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
An De Groef, Universitaire Ziekenhuizen Leuven

Brief Summary:
Development and internal validation of an easy-to-use tool for clinical pain assessment. The tool has to be applicable in any clinical practice and without the need for expensive and complicated hospital tools to identify the source of persistent pain after the treatment of cancer.

Condition or disease Intervention/treatment
Cancer Survivors Cancer Pain Diagnostic Test: Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent pain

Detailed Description:

An adequate selection of physiotherapy treatment for persistent pain after the treatment of cancer, depends highly on the mechanism of the pain.

Pain can arise from a damaged nerve or tissue (skin, lymphatic system...). But when pain becomes chronic, alterations to the central nervous system can occur, as regulations of the facilitating and inhibiting mechanisms. These alterations may cause central sensitization pain. The body is now sensitized and cannot distinct harmful from harmless stimuli.

Each type of pain requires a specific treatment, therefore identification of the pain mechanism is crucial. Up till now, expensive and complex tests were performed in a hospital setting to determine if a patient suffers from neuropathic, nociceptive or central sensitization pain. This study aims for developping an assessment tool that does not require expensive devices but can be easily performed by any physiotherapist, within the timeframe of a standard consultation.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : November 16, 2020
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent pain
    Easy-to-use screening tool to identify the dominant pain mechanism by using quick clinical tests and compare their accuracy and validity with complicated reference tests.


Primary Outcome Measures :
  1. Douleur Neuropathic 4 questions (DN4) questionnaire [ Time Frame: 2 minutes ]
    Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)

  2. Quantitative sensory testing [ Time Frame: 20 minutes ]
    Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)

  3. Pain mapping [ Time Frame: 1 minute ]
    Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)

  4. Central Sensitization Inventory (CSI) questionnaire [ Time Frame: 5 minutes ]
    Central sensitization pain: pain caused by changes in the central nervous system is assessed with a questionnaire (1)

  5. Conditioned pain modulation [ Time Frame: 10 minutes ]
    Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)

  6. Temporal summation [ Time Frame: 2,5 minutes ]
    Central sensitization pain: pain caused by changes in the central nervous system is assessed with a series of touch stimuli (3)

  7. Diffuse pain [ Time Frame: 0,5 minute ]
    Central sensitization pain: pain caused by changes in the central nervous system is assessed by painting affected areas on a body chart (4)

  8. Manual palpation [ Time Frame: 3 minutes ]
    Central sensitization pain: pain caused by changes in the central nervous system is assessed by applying pressure with manual palpation (5)

  9. Evaluation of skin [ Time Frame: 20 seconds ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)

  10. Lymphedema [ Time Frame: 4 minutes ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the presence of lymphedema by measuring the circumference of the arm (2)

  11. Joint pain [ Time Frame: 30 seconds ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by examining if several joints are sore, especially in the morning (3)

  12. Active mobility [ Time Frame: 2,5 minutes ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the patient can perform (4)

  13. Passive mobility [ Time Frame: 3,5 minutes ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the clinician can perform on the patient (5)

  14. Strength [ Time Frame: 1,5 minutes ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by the strength the patient can perform in a specific movement (6)

  15. Scar tissue [ Time Frame: 2 minutes ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the elasticity of the scar tissue by manual palpation of the clinician (7)

  16. Axillary web syndrome [ Time Frame: 2 minutes ]
    Nociceptive pain: pain that arises from a damaged tissue is assessed by visually examining the presence of lymph cords in the axilla (8)


Secondary Outcome Measures :
  1. Pain catastrophizing scale [ Time Frame: 6 minutes ]
    Pain catastrophizing scale

  2. Depression, anxiety and stress [ Time Frame: 7 minutes ]
    Depression Anxiety and Stress Scale (DASS-21)

  3. Pain Self-efficacy and Expectations: questionnaire [ Time Frame: 5 minutes ]
    Pain self-efficacy and expectations questionnaire

  4. Pain character: questionnaire [ Time Frame: 4 minutes ]
    McGill Pain questionnaire

  5. Pain disability: Pain Disability Index [ Time Frame: 3 minutes ]
    Pain Disability Index

  6. Pain intensity: Visual Analogue Scale [ Time Frame: 1 minute ]
    Visual Analogue Scale at the moment, worst and least pain during the past week

  7. Pain questionnaire [ Time Frame: 30 seconds ]
    Brief Pain Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer patients older than 18, in complete remission, who experience pain scored with a minimum of 3/10 (0 being no pain at all and 10 being the worst pain imaginable). The patients do not have metastasis and are not in a palliative status, nor are they pregnant or diagnosed with a cancer type other than breast, prostate, lung/bronchus, colon/rectum or gynecologic cancer.
Criteria

Inclusion Criteria:

  • Patient treated for primary cancer: breast, prostate, lung/bronchus, colon/rectum, gynecologic (uterus or ovary)
  • Complete remission
  • Curative treatment finished
  • Ongoing hormonal and targeted treatment permitted
  • Patient experiences pain (NRS minimum 3/10 during the past week)

Exclusion Criteria:

  • Active metastasis
  • Palliative status
  • Other type of cancer than mentioned in inclusion criteria
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981809


Contacts
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Contact: Frauke Penen, Dra. +32 16 194309 frauke.penen@kuleuven.be
Contact: An De Groef, Dr. 32 16 342171 an.degroef@kuleuven.be

Locations
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Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: An De Groef    003216342171    an.degroef@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
Investigators
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Study Director: Nele Devoogdt, Prof. UZ Leuven

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Responsible Party: An De Groef, Principal investigator An De Groef, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03981809     History of Changes
Other Study ID Numbers: S62584
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by An De Groef, Universitaire Ziekenhuizen Leuven:
Pain
Cancer
Chronic pain
Persistent pain

Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms