Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-05
Brief Title:
Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
Sponsor:
International Institute of Behavioral Medicines
Organization:
International Institute of Behavioral Medicines
Study Overview
Official Title:
Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment Relationships among the different outcome measures will be also evaluated
Detailed Description:
This is an observational study aimed at evaluating the responsiveness and minimal important change of two different graphical ways to assess pain intensity in people with low back pain
Literature found out that low back pain intensity is commonly assessed by a numerical rating scale ranging from no pain to the worst imaginable pain once presented to responders horizontally A different way to assess pain intensity could be to answer a similar numerical rating scale if set vertically
In Literature there are not studies which head-to-head evaluate the responsiveness and minimal important change of these two ways of assessing pain intensity due to low back pain
Participants will also have to complete self-reported outcome measures of disability catastrophizing fear of movement and self-efficacy and correlations among these tools and the above two different ways to evaluate pain intensity will be evaluated Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample under investigation
Literature found out that low back pain intensity is commonly assessed by a numerical rating scale ranging from no pain to the worst imaginable pain once presented to responders horizontally A different way to assess pain intensity could be to answer a similar numerical rating scale if set vertically
In Literature there are not studies which head-to-head evaluate the responsiveness and minimal important change of these two ways of assessing pain intensity due to low back pain
Participants will also have to complete self-reported outcome measures of disability catastrophizing fear of movement and self-efficacy and correlations among these tools and the above two different ways to evaluate pain intensity will be evaluated Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample under investigation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None