Low Back PainNCT06270069
Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
An observational study of Low Back Pain, run by International Institute of Behavioral Medicines.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Excercise-based therapy
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Non specific low back pain
- Adult age
- Ability to understand the Italian language
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Excercise-based therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excercise-based therapyOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity (horizontal line)
Measured: 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)
Measured: Immediately before the rehab treatment starts and immediately after the intervention
Secondary outcomes (5)
ODI
Oswestry Disability Index; score 0-50 with higher scores representing greater restriction to activities.
Measured: Immediately before the rehab treatment starts and immediately after the intervention
PCS
Pain Catastrophizing Scale; score 0-52 with higher estimates showing higher catastrophizing
Measured: 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
Measured: 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
Measured: 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)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Behavioral Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270069
- Sponsor's protocol ID
- 2024-001
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
- ClinicalTrials.gov ID
- NCT06270069
- Acronym / sponsor ID
- 2024-001
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- International Institute of Behavioral MedicinesUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Non specific low back pain
- Adult age
- Ability to understand the Italian language
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excercise-based therapyAn 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 | Other | – |
Primary outcome
NRS
Time frame: Immediately before the rehab treatment starts and immediately after the intervention
Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity (horizontal line)
Gauge of pain
Time frame: Immediately before the rehab treatment starts and immediately after the intervention
Numerical Rating Scale; score -5/+5 with lower estimates indicating higher levels of pain intensity (vertical line)
5 secondary outcomes
ODI
Time frame: Immediately before the rehab treatment starts and immediately after the intervention
PCS
Time frame: Immediately before the rehab treatment starts and immediately after the intervention
TSK
Time frame: Immediately before the rehab treatment starts and immediately after the intervention
PSEQ
Time frame: Immediately before the rehab treatment starts and immediately after the intervention
GPE
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by International Institute of Behavioral Medicines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Rocca, MSC (3333653393, info.ellis.bm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Immediately before the rehab treatment starts and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.