Transcultural Validation of the French Version of the Functional Pain Scale "Defense and Veterans Pain Rating Scale"

Pain Clinical Trial

— VALIDE  

Official title:

Transcultural Validation of the French Version of the Functional Pain Scale "Defense and Veterans Pain Rating Scale DVPRS"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307380
• Other study ID #: VALIDE
• Status: Completed
• Start date: March 20, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The project will validate the French translation of the "Defense and Veterans Pain Rating Scale (DVPRS)" in multiple patient types: postoperative patients, non-surgical patients with chronic pain in the context of geriatrics, palliative care, and rehabilitation

Description:

The primary objective of this study is to validate the French translation of the multidimensional "Defence and Veterans Pain Rating Scale" (= functional pain scale).

The hypothesis is that the functional pain scale is a valid measurement instrument for acute and chronic pain evaluation in a wide range of patient groups: postoperative patients, hospitalized patients with non-surgical pain (medical, oncological, rehabilitative, geriatric, palliative), and ambulatory chronic pain patients.

The primary endpoint is construct validity assessed as the association (intraclass correlation coefficient) between the pain intensity noted on the functional pain scale and on the classical NRS pain scale.

In addition to the association with the NRS, construct validity will be assessed by correlation of pain intensity noted on the functional pain scale intensity with the pain intensity score of the BPI for chronic pain patients, and the item "severe pain time" of the International Pain Outcomes Questionnaire (8) for postoperative patients.

Content validity will be assessed in a subgroup of patient by the association of the values for pain intensity (0-10) on the functional pain scale and the corresponding word descriptors. A factor analysis of all items of the functional pain scale will be performed.

Internal consistency of the functional pain scale will be tested by calculating Cronbach's alpha across all items.

Criterion validity will be assessed in patients for whom mobilisation is an important therapeutic goal as the discrimation between patients who can be mobilized and those who can't because of pain, and patients who consider their pain as tolerable and those who do not.

This discrimative ability will also be compared to the classical numeric rating scale, as it is a potential advantage of the functional pain scale. For the numeric rating scale, a large overlap in pain intensity for patients who consider their pain as tolerable and those who do not has been found(9).

Sensitivity to change will be evaluated by comparing values before and after an analgesic treatment for a subgroup of patients with an initial pain intensity of at least 4/10 on the functional pain scale. However, since patients with high pain levels will not be able to fill in the questionnaire, this is only an exploratory endpoint of this study.

Patient and caregiver evaluation of ease of use will also be evaluated, as well as patient judgement of tolerable pain levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with acute or chronic pain, either having undergone painful surgical procedures, or having a chronic pain consultation, or being hospitalized in oncology, rehabilitative, geriatric or palliative care with painful conditions

• French-speaking and able to understand the study information

• =18 years of age

Exclusion Criteria:

• Inability to understand the consent form and the questionnaire, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

• Enrolment of the investigator, his/her family members, employees and other dependent persons

Related Conditions & MeSH terms

• Pain

Intervention

Diagnostic Test:
• "functional pain scale"
French translation of the Defence and Veterans Pain Rating Scale (DVPRS)

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Genève
Switzerland	Hôpital du Valais	Sion	Valais

Sponsors (2)

Lead Sponsor	Collaborator
Benno Rehberg-Klug	Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	construct validity for acute pain	association (intraclass correlation coefficient) between the pain intensity noted on the functional pain scale and on the classical NRS pain scale.	immediate after inclusion
Secondary	construct validity for chronic pain	correlation of pain intensity noted on the functional pain scale intensity with the pain intensity score of the BPI for chronic pain patients	immediate after inclusion
Secondary	Criterion validity: ability to be mobilized	ability to be mobilized as noted by the caregiver: the patient cannot be mobilized due to pain vs. mobilisation is possible	immediate after inclusion
Secondary	Criterion validity : pain intensity considered as tolerable	pain intensity considered as tolerable by the patient on a 0 to 10 numeric scale	immediate after inclusion
Secondary	Sensitivity to change	comparison of values before and after an analgesic treatment for a subgroup of patients with an initial pain intensity of at least 4/10 on the functional pain scale	immediate after inclusion
Secondary	Patient and caregiver evaluation of ease of use	Patient and caregiver evaluation of ease of use evaluated on a Likert-scale	immediate after inclusion