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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Excercise-based therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Barbara Rocca, MSC; Phone Number: 3333653393; Email: info.ellis.bm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Non-specific low back pain is defined as low back pain not attributable to a recognizable, known specific pathology (eg, infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder,radicular syndrome, or cauda equina syndrome).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity (horizontal line)	Immediately before the rehab treatment starts and immediately after the intervention
Gauge of pain	Numerical Rating Scale; score -5/+5 with lower estimates indicating higher levels of pain intensity (vertical line)	Immediately before the rehab treatment starts and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ODI	Oswestry Disability Index; score 0-50 with higher scores representing greater restriction to activities.	Immediately before the rehab treatment starts and immediately after the intervention
PCS	Pain Catastrophizing Scale; score 0-52 with higher estimates showing higher catastrophizing	Immediately before the rehab treatment starts and immediately after the intervention
TSK	Tampa Scale of Kinesiophobia; score 13-52 with higher estimates showing higher fear of movement	Immediately before the rehab treatment starts and immediately after the intervention
PSEQ	Pain Self Efficacy Questionnaire; score 0-60 with higher estimates showing higher self-effficacy	Immediately before the rehab treatment starts and immediately after the intervention
GPE	Global Perceived Effect (how much did the treatment received help your pain?); score -3 (it worsen a lot the things)/+3 (it helped a lot)	Immediately after the intervention

Collaborators and Investigators

• Sponsor: International Institute of Behavioral Medicines

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Back Pain; Low Back Pain; Pain
• Other Study ID Numbers: 2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No