NCT06270069

Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: International Institute of Behavioral Medicines · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Excercise-based therapy	An individual 60-min motor training sessions twice a week for eight-week outpatient program, that included exercises aimed at improving postural control, strengthening and stabilizing the back muscles, and stretching

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-02-21
• Last updated: 2024-02-21