Acute Back PainPhase 4NCT03171987
The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
A Phase 4 study testing Lidocaine patch local application and Flurbiprofen patch local application in people with Acute Back Pain, run by Taipei Medical University Hospital at 2 sites in Taiwan.
Trial summary
This is a prospective, randomized, single blinded, two-arm, head to head study. The purpose of this study is: To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for treatment of acute low back pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Back Pain
- What is being tested?
- Lidocaine patch local application and Flurbiprofen patch local application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesTaiwan
- Study dates
- 14 Jun 2017to 30 Jun 2021
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects underwent a detailed history and systemic physical examination including neurologic and musculoskeletal evaluations. To rule out any confounding etiologies, basic diagnostic laboratory tests including complete blood count and acute phase reactants (erythrocyte sedimentation rate and C-reactive protein) were performed. The patients diagnosed as having acute non-specific low back pain according to history and physical examinations were invited to participate and will be informed about the purpose and course of the study.
- Main inclusion criteria
- A primary complaint of pain in the area between the 12th rib and buttock crease without leg pain
- Female or male, 20 - 80 years of age
- Low back pain of less than six weeks' duration; and at least moderate pain intensity (NRS≧4)
Who cannot join
- Main exclusion criteria:
- Known or suspected serious spinal pathology and spinal implants
- Lumbar spinal surgery within the preceding six months
- Serious comorbidities preventing prescription of paracetamol
- Alternative treatment for low back pain in previous two weeks
- Chronic neurological lesion
Show all 12Show fewer
- Chronic musculoskeletal lesion
- Active cancer
- Pregnancy
- Use of pain medication (except paracetamol) within 3 days
- Treatment site has active skin lesion or inflammation
- Known allergy to skin patch
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Postal Hospital
Taipei, 11031
Taipei Medical University Hospital
Taipei, 110
About this study
This is a prospective, randomized, single blinded, two-arm, head to head study.
The purpose of this study is:
Read more
- To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for treatment of acute low back pain.
Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving functional disabilities and in reducing pain resulting from acute low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to 1-Months.
- Conditions
- Acute Back Pain
- Being tested
- Lidocaine patch local application, Flurbiprofen patch local application
- Keywords
- lidocaine patch, flurbiprofen patch, acute back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patch local applicationDrug
Also called Lidopat patch
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
Flurbiprofen patch local applicationDrug
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine patch | Experimental | Lidocaine patch local application 1 piece per day for 28 days at back pain area. Receives: Drug: Lidocaine patch local application |
| Flurbiprofen patch | Active comparator | Flurbiprofen patch local application 1 piece per day for 28 days at back pain area. Receives: Drug: Flurbiprofen patch local application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
Back pain relief effectiveness
Measured: 28 day
Secondary outcomes (10)
Numeric rating scale (NRS)
Back pain relief effectiveness
Measured: 0, 1, 3, 7, 14, 21 day
Brief Pain Inventory-Quality of Life (BPI-QoL)
Back pain relief effectiveness
Measured: 0, 7, 14, 21, 28 day
Oswestry Disability Questionnaire (ODQ)
Back pain relief effectiveness
Measured: 0, 7, 14, 21, 28 day
Core Outcome Measurement Index (COMI)
Back pain relief effectiveness
Measured: 0, 7, 14, 21, 28 day
EQ5D Quality of Life questionnaires Efficacy
Back pain relief effectiveness
Measured: 0, 7, 14, 21, 28 day
Short form-Mcgill Pain Questionnaire (SF-MPQ-2)
Back pain relief effectiveness
Measured: 0, 7, 14, 21, 28 day
Overall Treatment Effect Scale (OTE)
Back pain relief effectiveness
Measured: 7, 14, 21, 28 day
Analgesic consumption
Back pain relief effectiveness
Measured: 7, 14, 21, 28 day
Skin reaction grade (Assessment of dermal response)
Safety
Measured: 1, 3, 7, 14, 21, 28 days
Common Terminology Criteria for Adverse Events (CTCAE)
Safety
Measured: 1, 3, 7, 14, 21, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start14 Jun 2017
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Lidocaine patch group: 1 piece lidocaine patch per day at back pain area. The treatment lasts for 28 days. 2. Flurbiprofen patch group: 1 piece flurbiprofen patch per day at back pain area. The treatment lasts for 28 days.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Huang Wu, Taipei Medical University Hospital
- Investigators
- Ray-Jade Chen, MD, Study chair, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171987
- Sponsor's protocol ID
- N201702048
- Status last verified
- Mar 2021
- First submitted
- 24 May 2017
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No shore IPD plan.
Publications
Coste J, Lefrancois G, Guillemin F, Pouchot J; French Study Group for Quality of Life in Rheumatology. Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study. Arthritis Rheum. 2004 Apr 15;51(2):168-76. doi: 10.1002/art.20235.
PubMed 15077256Mick G, Correa-Illanes G. Topical pain management with the 5% lidocaine medicated plaster--a review. Curr Med Res Opin. 2012 Jun;28(6):937-51. doi: 10.1185/03007995.2012.690339. Epub 2012 May 24.
PubMed 22551228Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5.
PubMed 7917798
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT03171987
- Acronym / sponsor ID
- N201702048
- Conditions
- Acute Back Pain
- Keywords
- lidocaine patch, flurbiprofen patch, acute back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 31 May 2017 (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 a prospective, randomized, single blinded, two-arm, head to head study.
The purpose of this study is:
- To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for treatment of acute low back pain.
Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving functional disabilities and in reducing pain resulting from acute low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to 1-Months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- 1. Lidocaine patch group: 1 piece lidocaine patch per day at back pain area. The treatment lasts for 28 days. 2. Flurbiprofen patch group: 1 piece flurbiprofen patch per day at back pain area. The treatment lasts for 28 days.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine patch | Experimental | Drug: Lidocaine patch local applicationLidocaine patch local application 1 piece per day for 28 days at back pain area. |
| Flurbiprofen patch | Active comparator | Drug: Flurbiprofen patch local applicationFlurbiprofen patch local application 1 piece per day for 28 days at back pain area. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects underwent a detailed history and systemic physical examination including neurologic and musculoskeletal evaluations. To rule out any confounding etiologies, basic diagnostic laboratory tests including complete blood count and acute phase reactants (erythrocyte sedimentation rate and C-reactive protein) were performed. The patients diagnosed as having acute non-specific low back pain according to history and physical examinations were invited to participate and will be informed about the purpose and course of the study.
- Main inclusion criteria
- A primary complaint of pain in the area between the 12th rib and buttock crease without leg pain
- Female or male, 20 - 80 years of age
- Low back pain of less than six weeks' duration; and at least moderate pain intensity (NRS≧4)
Key exclusion criteria (12 listed)
- Known or suspected serious spinal pathology and spinal implants
- Lumbar spinal surgery within the preceding six months
- Serious comorbidities preventing prescription of paracetamol
- Alternative treatment for low back pain in previous two weeks
- Chronic neurological lesion
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 |
|---|---|---|
| Lidocaine patch local applicationAlso: Lidopat patchAttach the patch to back pain area 1 piece per day with no more than 6 hours. | Drug | Lidocaine patch |
| Flurbiprofen patch local applicationAttach the patch to back pain area 1 piece per day with no more than 6 hours. | Drug | Flurbiprofen patch |
Primary outcome
Numeric rating scale (NRS)
Time frame: 28 day
Back pain relief effectiveness
10 secondary outcomes
Numeric rating scale (NRS)
Time frame: 0, 1, 3, 7, 14, 21 day
Brief Pain Inventory-Quality of Life (BPI-QoL)
Time frame: 0, 7, 14, 21, 28 day
Oswestry Disability Questionnaire (ODQ)
Time frame: 0, 7, 14, 21, 28 day
Core Outcome Measurement Index (COMI)
Time frame: 0, 7, 14, 21, 28 day
EQ5D Quality of Life questionnaires Efficacy
Time frame: 0, 7, 14, 21, 28 day
Short form-Mcgill Pain Questionnaire (SF-MPQ-2)
Time frame: 0, 7, 14, 21, 28 day
Overall Treatment Effect Scale (OTE)
Time frame: 7, 14, 21, 28 day
Analgesic consumption
Time frame: 7, 14, 21, 28 day
Skin reaction grade (Assessment of dermal response)
Time frame: 1, 3, 7, 14, 21, 28 days
Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 1, 3, 7, 14, 21, 28 days
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 10 Apr 2024.
- Background: PubMed 15077256Coste J, Lefrancois G, Guillemin F, Pouchot J; French Study Group for Quality of Life in Rheumatology. Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study. Arthritis Rheum. 2004 Apr 15;51(2):168-76. doi: 10.1002/art.20235.
- Background: PubMed 22551228Mick G, Correa-Illanes G. Topical pain management with the 5% lidocaine medicated plaster--a review. Curr Med Res Opin. 2012 Jun;28(6):937-51. doi: 10.1185/03007995.2012.690339. Epub 2012 May 24.
- Background: PubMed 7917798Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5.
- Individual participant dataSharing planned: No. No shore IPD plan.
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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.
Ray-Jade Chen, MD study chair
Taipei Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine patch local application and Flurbiprofen patch local application in people with Acute Back Pain, run by Taipei Medical University Hospital at 2 sites in Taiwan.
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 12 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Numeric rating scale (NRS) (time frame: 28 day). 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 NCT03171987, which also lists 3 linked publications.
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 10 Apr 2024.