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出境医 / 临床实验 / Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan (PainsCan)
Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan (PainsCan)
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cancer Survivors Cancer Pain | 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 Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 350 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain |
| Actual Study Start Date : | June 13, 2019 |
| Estimated Primary Completion Date : | November 16, 2021 |
| Estimated Study Completion Date : | November 30, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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)
- Quantitative sensory testing [ Time Frame: 20 minutes ]Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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 Outcome Measures :
- Pain catastrophizing scale [ Time Frame: 6 minutes ]Pain catastrophizing scale
- Depression, anxiety and stress [ Time Frame: 7 minutes ]Depression Anxiety and Stress Scale (DASS-21)
- Pain Self-efficacy and Expectations: questionnaire [ Time Frame: 5 minutes ]Pain self-efficacy and expectations questionnaire
- Pain character: questionnaire [ Time Frame: 4 minutes ]McGill Pain questionnaire
- Pain disability: Pain Disability Index [ Time Frame: 3 minutes ]Pain Disability Index
- Pain intensity: Visual Analogue Scale [ Time Frame: 1 minute ]Visual Analogue Scale at the moment, worst and least pain during the past week
- Pain questionnaire [ Time Frame: 30 seconds ]Brief Pain Inventory
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||||||
| First Posted Date | June 11, 2019 | ||||||||
| Last Update Posted Date | November 3, 2020 | ||||||||
| Actual Study Start Date | June 13, 2019 | ||||||||
| Estimated Primary Completion Date | November 16, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan | ||||||||
| Official Title | Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain | ||||||||
| 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | 1 Day | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition |
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| 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.
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
350 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | November 30, 2022 | ||||||||
| Estimated Primary Completion Date | November 16, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Belgium | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03981809 | ||||||||
| Other Study ID Numbers | S62584 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | An De Groef, Universitaire Ziekenhuizen Leuven | ||||||||
| Study Sponsor | Universitaire Ziekenhuizen Leuven | ||||||||
| Collaborators | Fund for Scientific Research, Flanders, Belgium | ||||||||
| Investigators |
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| PRS Account | Universitaire Ziekenhuizen Leuven | ||||||||
| Verification Date | November 2020 | ||||||||
