Chronic Low Back PainPhase 3NCT02387567
Paraspinal Block in Nonspecific Low Back Pain
A Phase 3 study testing Lidocaine and Standard treatment in people with Chronic Low Back Pain, run by Marta Imamura at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lidocaine and Standard treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Jan 2013
- Phase
- Phase 3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 to 60 years;
- Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment with anti-inflammatory drugs for 3 months;
- Moderate to severe pain: visual analog scale (VAS) > 4;
- Diagnosis of chronic nonspecific low back pain;
- MiniMental test (MEEM) between 24 and 30;
- Availability to comply with the visits;
- Agree with signing the Informed Consent Form
Who cannot join
- Severe psychiatric disease that requires psychiatric care;
- Neurological disorders (lumbosciatic pain);
- Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of Rheumatology
- Concurrent rheumatic disease
- History of allergy to lidocaine (used for paraspinal blocks)
- Labor problems
- History of surgery on the lumbar spine
- No availability to visit the clinic for treatment and evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain
The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.
Read the detailed description
This trial was conducted in the Department of Rehabilitation, Hospital das Clinicas, University, of Sao Paulo Medical School, one of the largest rehabilitation centers in Brazil. The trial was initiated in January of 2007 and close to enrollment in January of 2013. Investigators included patients with a diagnosis of chronic nonspecific low back pain who were referred from various clinics in São Paulo that were linked to this rehabilitation center. Thus, patients were referred primarily by physiatrists, general practitioners, neurologists, orthopedic surgeons, and physiotherapists.
Participants were randomized to receive: (i) paraspinal lidocaine injection (LID-INJ) and standard treatment, (ii) sham lidocaine injection (SH-INJ) and standard treatment, or (iii) standard treatment only (STD-TTR). Randomization was performed using a computerized random number generator.
Assessments The evaluations were performed by an independent and blinded appraiser before treatment, after 1 week, and 3 months after the end of the applications. Baseline assessments consisted of a demographic and baseline clinical assessment [gender, age, occupation, duration of pain (months), pain intensity, associated diseases, and usual occupation] and a physical examination [measurements of weight and height to calculate body mass index (BMI)].
Primary Outcome Measure The primary outcome measure was the visual analog scale (VAS) score for pain. The VAS comprised a 10-cm ruler from 0 to 10, with 0 corresponding to no pain and 10 corresponding to maximum pain. Patients were asked to rate their average pain in the preceding 24 hs.
Secondary Outcome Measures Investigators also measured low back pain using the Brazilian Roland-Morris tool, which consisted of a specific questionnaire to assess function in patients with low back pain and has been validated in Brazil. Scores range from 0 to 24, wherein higher scores reflect greater disability due to low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lidocaine, Sham Lidocaine, Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called 3ml lidocaine 1% Injection
Paraspinal block with 3ml lidocaine injection at 1%.
Sham LidocaineDrug
Also called 3ml sham injection
Sham injection, without lidocaine.
Standard treatmentOther
Also called Lowback pain standard treatment
Standard treatment only, without lidocaine or sham injection.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment. Receives: Drug: Lidocaine; Other: Standard treatment |
| Sham lidocaine | Sham comparator | Sham Injection, without lidocaine, combined with standard treatment. Receives: Drug: Sham Lidocaine; Other: Standard treatment |
| Standard treatment only | Active comparator | The only intervention is the standard treatment. No lidocaine or shame injection was used. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1
Measured: Baseline, week 1
Secondary outcomes (3)
Change from baseline in pain on the Brazilian Roland-Morris tool at week 1
Measured: Baseline, week 1
Change from baseline in pain on the Brazilian Roland-Morris tool at week 12
Measured: baseline, week 12
Change from baseline in pain on the visual analog scale (VAS) score for pain
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJan 2007
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Imamura
- Sponsor type
- University, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital
- Responsible party
- Sponsor-investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, MD, Principal investigator, Instituto de Medicina Física e Reabilitação HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387567
- Sponsor's protocol ID
- PS-block-Pain
- Other IDs
- U1111-1155-7609
- Status last verified
- Mar 2015
- First submitted
- 22 May 2014
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Imamura M, Imamura ST, Targino RA, Morales-Quezada L, Onoda Tomikawa LC, Onoda Tomikawa LG, Alfieri FM, Filippo TR, da Rocha ID, Neto RB, Fregni F, Battistella LR. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial. J Pain. 2016 May;17(5):569-76. doi: 10.1016/j.jpain.2016.01.469. Epub 2016 Jan 30.
PubMed 26828801
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT02387567
- Acronym / sponsor ID
- PS-block-Pain
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Marta ImamuraUniversity, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital
- Study start
- Jan 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Mar 2015 (estimated)
- 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 purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.
Detailed description
This trial was conducted in the Department of Rehabilitation, Hospital das Clinicas, University, of Sao Paulo Medical School, one of the largest rehabilitation centers in Brazil. The trial was initiated in January of 2007 and close to enrollment in January of 2013. Investigators included patients with a diagnosis of chronic nonspecific low back pain who were referred from various clinics in São Paulo that were linked to this rehabilitation center. Thus, patients were referred primarily by physiatrists, general practitioners, neurologists, orthopedic surgeons, and physiotherapists.
Participants were randomized to receive: (i) paraspinal lidocaine injection (LID-INJ) and standard treatment, (ii) sham lidocaine injection (SH-INJ) and standard treatment, or (iii) standard treatment only (STD-TTR). Randomization was performed using a computerized random number generator.
Assessments The evaluations were performed by an independent and blinded appraiser before treatment, after 1 week, and 3 months after the end of the applications. Baseline assessments consisted of a demographic and baseline clinical assessment [gender, age, occupation, duration of pain (months), pain intensity, associated diseases, and usual occupation] and a physical examination [measurements of weight and height to calculate body mass index (BMI)].
Primary Outcome Measure The primary outcome measure was the visual analog scale (VAS) score for pain. The VAS comprised a 10-cm ruler from 0 to 10, with 0 corresponding to no pain and 10 corresponding to maximum pain. Patients were asked to rate their average pain in the preceding 24 hs.
Secondary Outcome Measures Investigators also measured low back pain using the Brazilian Roland-Morris tool, which consisted of a specific questionnaire to assess function in patients with low back pain and has been validated in Brazil. Scores range from 0 to 24, wherein higher scores reflect greater disability due to low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine, Other: Standard treatmentParaspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment. |
| Sham lidocaine | Sham comparator | Drug: Sham Lidocaine, Other: Standard treatmentSham Injection, without lidocaine, combined with standard treatment. |
| Standard treatment only | Active comparator | Other: Standard treatmentThe only intervention is the standard treatment. No lidocaine or shame injection was used. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 20 to 60 years;
- Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment with anti-inflammatory drugs for 3 months;
- Moderate to severe pain: visual analog scale (VAS) > 4;
- Diagnosis of chronic nonspecific low back pain;
- MiniMental test (MEEM) between 24 and 30;
Key exclusion criteria (8 listed)
- Severe psychiatric disease that requires psychiatric care;
- Neurological disorders (lumbosciatic pain);
- Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of Rheumatology
- Concurrent rheumatic disease
- History of allergy to lidocaine (used for paraspinal blocks)
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 |
|---|---|---|
| LidocaineAlso: 3ml lidocaine 1% InjectionParaspinal block with 3ml lidocaine injection at 1%. | Drug | Lidocaine |
| Sham LidocaineAlso: 3ml sham injectionSham injection, without lidocaine. | Drug | Sham lidocaine |
| Standard treatmentAlso: Lowback pain standard treatmentStandard treatment only, without lidocaine or sham injection. | Other | Lidocaine, Sham lidocaine, Standard treatment only |
Primary outcome
Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1
Time frame: Baseline, week 1
3 secondary outcomes
Change from baseline in pain on the Brazilian Roland-Morris tool at week 1
Time frame: Baseline, week 1
Change from baseline in pain on the Brazilian Roland-Morris tool at week 12
Time frame: baseline, week 12
Change from baseline in pain on the visual analog scale (VAS) score for pain
Time frame: Baseline, week 12
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 13 Mar 2015.
- Derived from this study: PubMed 26828801Imamura M, Imamura ST, Targino RA, Morales-Quezada L, Onoda Tomikawa LC, Onoda Tomikawa LG, Alfieri FM, Filippo TR, da Rocha ID, Neto RB, Fregni F, Battistella LR. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial. J Pain. 2016 May;17(5):569-76. doi: 10.1016/j.jpain.2016.01.469. Epub 2016 Jan 30.
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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.
Marta Imamura, MD principal investigator
Instituto de Medicina Física e Reabilitação HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and Standard treatment in people with Chronic Low Back Pain, run by Marta Imamura at 1 site in Brazil.
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 7 inclusion and 8 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 13 Mar 2015. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1 (time frame: Baseline, week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387567, which also lists 1 linked publication.
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 13 Mar 2015.