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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06270069
• Other study ID #: 2024-001
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: International Institute of Behavioral Medicines
• Contact: Barbara Rocca, MSC
• Phone: 3333653393
• Email: info.ellis.bm[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Behavioral Medicines

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	PCS	Pain Catastrophizing Scale; score 0-52 with higher estimates showing higher catastrophizing	Immediately before the rehab treatment starts and immediately after the intervention
Secondary	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
Secondary	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
Secondary	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