Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03981809
Other study ID # S62584
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03375515 - PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain Phase 3
Recruiting NCT03431922 - Endovascular Denervation in Patients With Cancer Pain N/A
Not yet recruiting NCT05265052 - 3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain Phase 2
Withdrawn NCT05325164 - Methadone for 'Adenocarcinopathic' Pain Treatment Phase 3
Completed NCT02664987 - Analgesic Treatment for Cancer Pain in South East Asia N/A
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Active, not recruiting NCT04095234 - Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT) Phase 2
Recruiting NCT05800834 - Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT02609828 - Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy Phase 3
Completed NCT03331055 - PENS or TENS for Pain in Pancreatic Cancer N/A
Recruiting NCT05506878 - Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement N/A
Completed NCT00766831 - An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain Phase 4
Recruiting NCT05051735 - PARASTOP - Paracetamol With Strong Opioids Phase 3
Not yet recruiting NCT05348174 - Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients. N/A
Completed NCT05209906 - An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
Completed NCT03031938 - Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies Phase 3
Not yet recruiting NCT05594459 - Early Treatment With Invasive Technique in Cancer Pain Management N/A
Withdrawn NCT04666623 - Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain Phase 2
Not yet recruiting NCT05049811 - Effects of Mobile Medicine on Cancer Patients N/A