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

Cancer Pain Clinical Trial

— PainsCan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981809
• Other study ID #: S62584
• Status: Completed
• Start date: June 13, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Cancer Survivors

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Douleur Neuropathic 4 questions (DN4) questionnaire	Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)	2 minutes
Primary	Quantitative sensory testing	Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)	20 minutes
Primary	Pain mapping	Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)	1 minute
Primary	Central Sensitization Inventory (CSI) questionnaire	Central sensitization pain: pain caused by changes in the central nervous system is assessed with a questionnaire (1)	5 minutes
Primary	Conditioned pain modulation	Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)	10 minutes
Primary	Temporal summation	Central sensitization pain: pain caused by changes in the central nervous system is assessed with a series of touch stimuli (3)	2,5 minutes
Primary	Diffuse pain	Central sensitization pain: pain caused by changes in the central nervous system is assessed by painting affected areas on a body chart (4)	0,5 minute
Primary	Manual palpation	Central sensitization pain: pain caused by changes in the central nervous system is assessed by applying pressure with manual palpation (5)	3 minutes
Primary	Evaluation of skin	Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)	20 seconds
Primary	Lymphedema	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)	4 minutes
Primary	Joint pain	Nociceptive pain: pain that arises from a damaged tissue is assessed by examining if several joints are sore, especially in the morning (3)	30 seconds
Primary	Active mobility	Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the patient can perform (4)	2,5 minutes
Primary	Passive mobility	Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the clinician can perform on the patient (5)	3,5 minutes
Primary	Strength	Nociceptive pain: pain that arises from a damaged tissue is assessed by the strength the patient can perform in a specific movement (6)	1,5 minutes
Primary	Scar tissue	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)	2 minutes
Primary	Axillary web syndrome	Nociceptive pain: pain that arises from a damaged tissue is assessed by visually examining the presence of lymph cords in the axilla (8)	2 minutes
Secondary	Pain catastrophizing scale	Pain catastrophizing scale	6 minutes
Secondary	Depression, anxiety and stress	Depression Anxiety and Stress Scale (DASS-21)	7 minutes
Secondary	Pain Self-efficacy and Expectations: questionnaire	Pain self-efficacy and expectations questionnaire	5 minutes
Secondary	Pain character: questionnaire	McGill Pain questionnaire	4 minutes
Secondary	Pain disability: Pain Disability Index	Pain Disability Index	3 minutes
Secondary	Pain intensity: Visual Analogue Scale	Visual Analogue Scale at the moment, worst and least pain during the past week	1 minute
Secondary	Pain questionnaire	Brief Pain Inventory	30 seconds