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Clinical Trials/NCT03981809
NCT03981809
Completed
N/A

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

Universitaire Ziekenhuizen KU Leuven1 site in 1 country92 target enrollmentJune 13, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer Survivors
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
92
Locations
1
Primary Endpoint
Conditioned pain modulation
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2019
End Date
December 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

An De Groef

Principal investigator An De Groef

Universitaire Ziekenhuizen KU Leuven

Eligibility 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

Outcomes

Primary Outcomes

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)

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)

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)

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)

Quantitative sensory testing

Time Frame: 20 minutes

Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

  • Pain disability: Pain Disability Index(3 minutes)
  • Pain intensity: Visual Analogue Scale(1 minute)
  • Pain Self-efficacy and Expectations: questionnaire(5 minutes)
  • Pain catastrophizing scale(6 minutes)
  • Depression, anxiety and stress(7 minutes)
  • Pain character: questionnaire(4 minutes)
  • Pain questionnaire(30 seconds)

Study Sites (1)

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