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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Pain; Cancer Survivors
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

• Study Contact: Name: Vincent Haenen, Dra.; Phone Number: +32 16 345884; Email: Vincent.haenen@kuleuven.be
• Study Contact Backup: Name: An De Groef, Dr.; Phone Number: 32 16 342171; Email: an.degroef@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Douleur Neuropathic 4 questions (DN4) questionnaire	Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)	2 minutes
Quantitative sensory testing	Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)	20 minutes
Pain mapping	Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)	1 minute
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
Conditioned pain modulation	Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)	10 minutes
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
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
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
Evaluation of skin	Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)	20 seconds
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain catastrophizing scale	Pain catastrophizing scale	6 minutes
Depression, anxiety and stress	Depression Anxiety and Stress Scale (DASS-21)	7 minutes
Pain Self-efficacy and Expectations: questionnaire	Pain self-efficacy and expectations questionnaire	5 minutes
Pain character: questionnaire	McGill Pain questionnaire	4 minutes
Pain disability: Pain Disability Index	Pain Disability Index	3 minutes
Pain intensity: Visual Analogue Scale	Visual Analogue Scale at the moment, worst and least pain during the past week	1 minute
Pain questionnaire	Brief Pain Inventory	30 seconds

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Fund for Scientific Research, Flanders, Belgium
• Investigators: Study Director: Nele Devoogdt, Prof., UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Pain; Chronic pain; Persistent pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: S62584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No