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

International Institute of Behavioral Medicines

Status: Not yet enrolling

Conditions: Low Back Pain

Treatments: Other: Excercise-based therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06270069

2024-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non specific low back pain
• Adult age
• Ability to understand the Italian language

Exclusion criteria

• Refuse to adhere to the study
• Definite causes of low back pain
• Central or peripheral neurological signs
• Systemic illness or psychiatric deficits
• Recent myocardial infarction, cerebrovascular events, or chronic lung or renal diseases