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Completed

NCT Number: NCT03981809

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

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.

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Key information

Conditions

Cancer Survivors Cancer Pain Chronic Pain Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent pain

Diagnostic Test

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Official study title

Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain

Acronym: PainsCan

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2019
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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