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

NCT ID: NCT06270069

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Institute of Behavioral Medicines

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Barbara Rocca, MSC

Role: CONTACT

3333653393

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindful Walking in Low Back Pain
NCT01893073 COMPLETED NA
Exercise and Low Back Pain
NCT02029131 COMPLETED NA
The Course of Low Back Pain
NCT04419675 COMPLETED