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

NCT06270069 | Not Yet Recruiting

• 1 other identifier: 2024-001
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• ODI

  Immediately before the rehab treatment starts and immediately after the intervention

• PCS

  Immediately before the rehab treatment starts and immediately after the intervention

• TSK

  Immediately before the rehab treatment starts and immediately after the intervention

• PSEQ

  Immediately before the rehab treatment starts and immediately after the intervention

• GPE

  Immediately after the intervention

Interventions

Excercise-based therapy OTHER

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Institute of Behavioral Medicines: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Barbara Rocca, MSC

CONTACT

3333653393; info.ellis.bm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 21, 2024
• Study Start: March 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share