Low Back PainNCT05697848
Pain Education in Chronic Low Back Pain
A study testing Physiotherapy combined with Pain Education and Physiotherapy in people with Low Back Pain and Rehabilitation, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue. The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Rehabilitation, Pain
- What is being tested?
- Physiotherapy combined with Pain Education and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 4 Oct 2021to 31 Jul 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Patients with low back pain of musculoskeletal origin for at least 3 months
- Patients free from NSAID and/or opioid analgesic therapy for at least 1 month
- Years of education: over 13
- Italian mother-tongue
Who cannot join
- Presence of neurological symptoms on provocative tests
- Recent surgical procedure
- Patients suffering from fibromyalgia or other rheumatological pathology
- Psychiatric pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Education: Treatment of Patients Affected by Chronic Low Back Pain, Randomized Controlled Study
The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue.
The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a conventional treatment.
- Conditions
- Low Back Pain, Rehabilitation, Pain
- Being tested
- Physiotherapy combined with Pain Education, Physiotherapy
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy combined with Pain EducationOther
Patients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions.
PhysiotherapyOther
Patients with chronic low back pain receive manual therapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Pain Education group | Experimental | The patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ). Receives: Other: Physiotherapy combined with Pain Education |
| Control group | Active comparator | The patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ). Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
Measured: Baseline
NRS
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
Measured: 4 weeks
NRS
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
Measured: 6 months
PCS
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Measured: Baseline
PCS
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Measured: 4 weeks
PCS
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start4 Oct 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Gallotta, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697848
- Sponsor's protocol ID
- CE2556
- Status last verified
- Nov 2023
- First submitted
- 13 Jan 2023
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Education: Treatment of Patients Affected by Chronic Low Back Pain, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05697848
- Acronym / sponsor ID
- CE2556
- Conditions
- Low Back Pain, Rehabilitation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 26 Jan 2023 (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.
The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue.
The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Education group | Experimental | Other: Physiotherapy combined with Pain EducationThe patients of the experimental group will undergo pain education in addition to individual physiotherapy ( manual therapy and active exercises ). |
| Control group | Active comparator | Other: PhysiotherapyThe patients of the control group will undergo individual physiotherapy ( manual therapy and active exercises ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18
- Patients with low back pain of musculoskeletal origin for at least 3 months
- Patients free from NSAID and/or opioid analgesic therapy for at least 1 month
- Years of education: over 13
- Italian mother-tongue
Key exclusion criteria (4 listed)
- Presence of neurological symptoms on provocative tests
- Recent surgical procedure
- Patients suffering from fibromyalgia or other rheumatological pathology
- Psychiatric pathologies
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 |
|---|---|---|
| Physiotherapy combined with Pain EducationPatients with chronic low back pain receive manual therapy treatment combined with Pain Education sessions. | Other | Pain Education group |
| PhysiotherapyPatients with chronic low back pain receive manual therapy treatment | Other | Control group |
Primary outcome
NRS
Time frame: Baseline
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
NRS
Time frame: 4 weeks
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
NRS
Time frame: 6 months
Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)
PCS
Time frame: Baseline
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
PCS
Time frame: 4 weeks
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
PCS
Time frame: 6 months
Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy combined with Pain Education and Physiotherapy in people with Low Back Pain and Rehabilitation, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Baseline). The study lists 6 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 27 Nov 2023.