Clinical trial NCT06270069: Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
Official title: Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Low Back Pain
Lead sponsor: International Institute of Behavioral Medicines
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS
timeFrame: Immediately before the rehab treatment starts and immediately after the intervention
measure: Gauge of pain
timeFrame: Immediately before the rehab treatment starts and immediately after the intervention
Secondary outcomes:
measure: ODI
timeFrame: Immediately before the rehab treatment starts and immediately after the intervention
measure: PCS
timeFrame: Immediately before the rehab treatment starts and immediately after the intervention
measure: TSK
timeFrame: Immediately before the rehab treatment starts and immediately after the intervention
measure: PSEQ
timeFrame: Immediately before the rehab treatment starts and immediately after the intervention
measure: GPE
timeFrame: Immediately after the intervention
Other outcomes:
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