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

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Diagnostic test: "functional pain scale"

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

• Study Contact: Name: Benno Rehberg-Klug, MD; Phone Number: 402 +41 22 372 27; Email: breh@hcuge.ch
• Study Contact Backup: Name: Stanislas Mathivon, Msc; Phone Number: 402 +41 22 372 27; Email: stmn@hcuge.ch

Study Locations

• Switzerland
  • Genève, Switzerland
    • Hôpitaux universitaires de Genève
  • Valais
    • Sion, Valais, Switzerland, 1951
      • Hopital du Valais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 100 postoperative patients,
• 50 ambulatory chronic pain patients
• 50 hospitalized patients with non-surgical pain (medical, oncological, rehabilitative, geriatric, palliative),

In addition, the following subgroups are planned within the total of 200 patients:

• 30 postoperative patients with a pain intensity of at least 4 will receive the functional pain scale twice, before and after an analgesic on-demand treatment.
• 30 patients will receive a separate sheet on which they are asked to connect the numeric pain intensity values (0-10) to the word descriptors of the functional pain scale.
• 30 patients >75 years old

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with pain; patients with acute postoperative or post-traumatic pain or chronic pain	Diagnostic test: "functional pain scale"; French translation of the Defence and Veterans Pain Rating Scale (DVPRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Patient and caregiver evaluation of ease of use	Patient and caregiver evaluation of ease of use evaluated on a Likert-scale	immediate after inclusion

Collaborators and Investigators

• Sponsor: Benno Rehberg-Klug
• Collaborators: Hôpital du Valais
• Investigators: Principal Investigator: Benno Rehberg-Klug, MD, Hôpitaux universitaires de Genève

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VALIDE

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