Acute Low Back PainPhase 3WHIPLASHNCT05001555

Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II

A Phase 3 study testing Dexketoprofen/Vitamin B and Dexketoprofen in people with Acute Low Back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Phase IIIb, multicenter, prospective, randomized, double-blind study to evaluate the fixed combination of Desketoprofen / Vitamin B in the management of acute pain in patients with cervical sprain grade I-II of the Quebec scale. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Acute Low Back Pain
What is being tested?: Dexketoprofen/Vitamin B and Dexketoprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 174 participants
Where: 1 siteMexico
Study dates: 23 Nov 2021to 25 Apr 2023
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Any sex.
That the subject agree to participate in the study and give your written informed consent.
Age> 18 years old at the beginning of the study.
Diagnosis of a grade I or Grade II cervical sprain on the Quebec scale of no more than 3 days.
Visual Analog Scale (VAS) ≥4 cm.
Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal), menopausal or surgically sterile.

Who cannot join

Patient in whom the drug is contraindicated for medical reasons.
History of allergic reaction to NSAIDs, thiamine, pyridoxine and cyanocobalamin or hypersensitivity to the components of the formula.
A significant history of gastrointestinal disorders (for example: Gastric Ulcer, Crohn's Disease, Ulcerative Colitis, etc.)
Previous treatment with opioids reported in the medical history.
History of inflammatory arthritis (eg rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout).
History of chronic pain (eg, fibromyalgia), metastasis, and Paget's disease.

Show all 20Show fewer

History of alcohol or drug abuse in the last year according to DSM-V.
Clinical and radiological data of cervical sprain grade III or IV of the Quebec scale.
History of illness or injury for more than 6 months in the neck or cervical spine
Patient with symptoms of spinal cord injury (weakness, incoordination or paralysis in any part of the body, numbness, tingling or loss of sensation in the hands, fingers, feet or toes, etc.)
History of severe acute or chronic liver failure.
History of moderate to severe renal failure.
A significant history of coagulation problems (Von Willembrand, hemophilia, vitamin K deficiency, etc.).
At medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver failure or mental illness or with scheduled surgical or hospital procedures.
History / presence of any disease or condition that, in the opinion of the Investigator, could pose a risk to the patient or confuse the efficacy and safety of the study results.
Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses.
Patients with symptoms suggesting an active COVID-19 infection (ie, fever, cough, dyspnea) and / or contact in the past 14 days with a suspected or positive COVID-19 patient.
Patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.)
Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, 11000

Other trials in Mexico

About this study

Official title: Efficacy and Safety of the Combination Dexketoprofen / Vitamin B Vs Dexketoprofen in the Treatment of Pain in Patients with Post-traumatic Cervical Sprain Grade I-II of the Quebec Scale.

Read the detailed description

Study to evaluate the efficacy and safety of the Dexketoprofen / Vitamin B combination versus dexketoprofen for the management of acute pain secondary to post-traumatic cervical sprain grade I-II of the Quebec scale, evaluated by means of the Visual Analogue Scale (VAS). To compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire in Spanish version on days 3, 5, and 7 compare to its baseline measurement between the treatment groups. Compare the proportion of subjects requiring rescue medication during the study between treatment groups. Describe the frequency and intensity of adverse events presented during the study.

Conditions: Acute Low Back Pain
Being tested: Dexketoprofen/Vitamin B, Dexketoprofen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexketoprofen/Vitamin BDrug
Also called D/VitB
1 capsule containing 25 mg of dexketoprofen / vitamin B (thiamine mononitrate 100 mg, Pyridoxine hydrochloride 50 mg, Cyanocobalamin 0.50 mg), orally, every 8 hours, for 7 days.
DexketoprofenDrug
Also called D
1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.

Study groups in NCT05001555
Study group	Role	What they receive
Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)	Experimental	Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin), 1 capsule, orally, every 8 hours, for 7 days. Receives: Drug: Dexketoprofen/Vitamin B
Group B: Dexketoprofen	Active comparator	Group B: Dexketoprofen, 1 tablet, orally, every 8 hours, for 7 days. Receives: Drug: Dexketoprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in pain intensity
Compare changes in pain intensity measured by the visual analog scale (VAS) between treatment groups. The VAS for pain is a straight line of 10 centimeters in which one end means no pain and the other end means the worst pain imaginable.
Measured: Baseline, 3, 5 and 7 days
Change in the degree of disability
Compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire Spanish version between the treatment groups. It includes 9 questions or items (intensity of neck pain, and sleep, pins and needles in the arms at night, duration of symptoms, lifting weights, reading and watching TV, work, social activities and driving). Each of these questions has five possible answers with a score of 0 to 4, from less to greater intensity and severity respectively.
Measured: Baseline, 3, 5 and 7 days
Proportion of subjects requiring rescue medication
Compare the proportion of subjects requiring rescue medication during the study between treatment groups.
Measured: 7 days
Adverse events frequency
Compare the proportion of subjects that presented an adverse event between treatment groups.
Measured: 7 days
Adverse events intensity
Compare the intensity of adverse events presented during the study, between treatment groups.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202125 Apr 2023

First posted12 Aug 2021
Study start23 Nov 2021
Primary completion24 Apr 2023
Study completion25 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Acute 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05001555
Sponsor's protocol ID: SIL-30242-III-20 (1)
Acronym: WHIPLASH
Status last verified: Nov 2024
First submitted: 29 Jul 2021
Last updated: 13 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. No abstract available.
PubMed 7604354
Rodriquez AA, Barr KP, Burns SP. Whiplash: pathophysiology, diagnosis, treatment, and prognosis. Muscle Nerve. 2004 Jun;29(6):768-81. doi: 10.1002/mus.20060.
PubMed 15170609
Hartling L, Brison RJ, Ardern C, Pickett W. Prognostic value of the Quebec Classification of Whiplash-Associated Disorders. Spine (Phila Pa 1976). 2001 Jan 1;26(1):36-41. doi: 10.1097/00007632-200101010-00008.
PubMed 11148643
Bagan JV, Lopez Arranz JS, Valencia E, Santamaria J, Eguidazu I, Horas M, Forns M, Zapata A, Artigas R, Mauleon D. Clinical Comparison of Dexketoprofen Trometamol and Dipyrone in Postoperative Dental Pain. J Clin Pharmacol. 1998 Dec;38(S1):55S-64S. doi: 10.1002/jcph.1998.38.s1.55.
PubMed 29023870
Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, Monroy-Maya R, Soto-Rios M, Carrillo-Alarcon L, Reyes-Garcia G, Fernandez-Martinez E. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.
PubMed 22135737
Curatolo M, Sveticic G. Drug combinations in pain treatment: a review of the published evidence and a method for finding the optimal combination. Best Pract Res Clin Anaesthesiol. 2002 Dec;16(4):507-19. doi: 10.1053/bean.2002.0254.
PubMed 12516888
Levin OS, Moseikin IA. [Vitamin B complex (milgamma) in the treatment of vertebrogenic lumbosacral radiculopathy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(10):30-5. Russian.
PubMed 20037567
Kuhlwein A, Meyer HJ, Koehler CO. [Reduced diclofenac administration by B vitamins: results of a randomized double-blind study with reduced daily doses of diclofenac (75 mg diclofenac versus 75 mg diclofenac plus B vitamins) in acute lumbar vertebral syndromes]. Klin Wochenschr. 1990 Jan 19;68(2):107-15. doi: 10.1007/BF01646857. German.
PubMed 2138683
Perez-Flores E, Medina-Santillan R, Reyes-Garcia G, Mateos-Garcia E. Combination of diclofenac plus B vitamins in acute pain after tonsillectomy: a pilot study. Proc West Pharmacol Soc. 2003;46:88-90. No abstract available.
PubMed 14699896
Mibielli MA, Geller M, Cohen JC, Goldberg SG, Cohen MT, Nunes CP, Oliveira LB, da Fonseca AS. Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study. Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.
PubMed 19731994
Gonzalez T, Balsa A, Sainz de Murieta J, Zamorano E, Gonzalez I, Martin-Mola E. Spanish version of the Northwick Park Neck Pain Questionnaire: reliability and validity. Clin Exp Rheumatol. 2001 Jan-Feb;19(1):41-6.
PubMed 11247324
Gaskell H, Derry S, Wiffen PJ, Moore RA. Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults. Cochrane Database Syst Rev. 2017 May 25;5(5):CD007355. doi: 10.1002/14651858.CD007355.pub3.
PubMed 28540716
Delgado-Garcia P, Alcocer-Herrera JB, Urenda-Quezada A, Alonso-Martinez MD, Bautista-Mendoza MA, Romero-Antonio Y, Mora-Villalobos JC, Sander-Padilla JG, Rios-Brito KF, Rodriguez-Vazquez IC, Gonzalez-Canudas J. A Randomized Control Trial of Dexketoprofen/Vitamin B (Thiamine, Pyridoxine and Cyanocobalamin) Fixed-Dose Combination in Post-Traumatic Grade I-II Cervical Sprains. Clin Drug Investig. 2024 Jun;44(6):413-424. doi: 10.1007/s40261-024-01370-2. Epub 2024 Jun 6.
PubMed 38842764

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of the Combination Dexketoprofen / Vitamin B Vs Dexketoprofen in the Treatment of Pain in Patients with Post-traumatic Cervical Sprain Grade I-II of the Quebec Scale.
ClinicalTrials.gov ID: NCT05001555
Acronym / sponsor ID: WHIPLASH / SIL-30242-III-20 (1)
Conditions: Acute Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 23 Nov 2021 (actual)
Primary completion: 24 Apr 2023 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 12 Aug 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)	Experimental	Drug: Dexketoprofen/Vitamin BGroup A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin), 1 capsule, orally, every 8 hours, for 7 days.
Group B: Dexketoprofen	Active comparator	Drug: DexketoprofenGroup B: Dexketoprofen, 1 tablet, orally, every 8 hours, for 7 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Any sex.
That the subject agree to participate in the study and give your written informed consent.
Age> 18 years old at the beginning of the study.
Diagnosis of a grade I or Grade II cervical sprain on the Quebec scale of no more than 3 days.
Visual Analog Scale (VAS) ≥4 cm.

Key exclusion criteria (20 listed)

Patient in whom the drug is contraindicated for medical reasons.
History of allergic reaction to NSAIDs, thiamine, pyridoxine and cyanocobalamin or hypersensitivity to the components of the formula.
A significant history of gastrointestinal disorders (for example: Gastric Ulcer, Crohn's Disease, Ulcerative Colitis, etc.)
Previous treatment with opioids reported in the medical history.
History of inflammatory arthritis (eg rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout).

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
Dexketoprofen/Vitamin BAlso: D/VitB1 capsule containing 25 mg of dexketoprofen / vitamin B (thiamine mononitrate 100 mg, Pyridoxine hydrochloride 50 mg, Cyanocobalamin 0.50 mg), orally, every 8 hours, for 7 days.	Drug	Group A: Dexketoprofen/Vitamin B (Thiamine mononitrate/Pyridoxine hydrochloride/Cyanocobalamin)
DexketoprofenAlso: D1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.	Drug	Group B: Dexketoprofen

Primary outcome

Changes in pain intensity
Time frame: Baseline, 3, 5 and 7 days
Compare changes in pain intensity measured by the visual analog scale (VAS) between treatment groups. The VAS for pain is a straight line of 10 centimeters in which one end means no pain and the other end means the worst pain imaginable.
Change in the degree of disability
Time frame: Baseline, 3, 5 and 7 days
Compare the degree of disability due to neck pain measured through the Northwick Park Neck Pain Questionnaire Spanish version between the treatment groups. It includes 9 questions or items (intensity of neck pain, and sleep, pins and needles in the arms at night, duration of symptoms, lifting weights, reading and watching TV, work, social activities and driving). Each of these questions has five possible answers with a score of 0 to 4, from less to greater intensity and severity respectively.
Proportion of subjects requiring rescue medication
Time frame: 7 days
Compare the proportion of subjects requiring rescue medication during the study between treatment groups.
Adverse events frequency
Time frame: 7 days
Compare the proportion of subjects that presented an adverse event between treatment groups.
Adverse events intensity
Time frame: 7 days
Compare the intensity of adverse events presented during the study, between treatment groups.

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 Nov 2024.
Background: PubMed 7604354Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. No abstract available.
Background: PubMed 15170609Rodriquez AA, Barr KP, Burns SP. Whiplash: pathophysiology, diagnosis, treatment, and prognosis. Muscle Nerve. 2004 Jun;29(6):768-81. doi: 10.1002/mus.20060.
Background: PubMed 11148643Hartling L, Brison RJ, Ardern C, Pickett W. Prognostic value of the Quebec Classification of Whiplash-Associated Disorders. Spine (Phila Pa 1976). 2001 Jan 1;26(1):36-41. doi: 10.1097/00007632-200101010-00008.
Background: PubMed 29023870Bagan JV, Lopez Arranz JS, Valencia E, Santamaria J, Eguidazu I, Horas M, Forns M, Zapata A, Artigas R, Mauleon D. Clinical Comparison of Dexketoprofen Trometamol and Dipyrone in Postoperative Dental Pain. J Clin Pharmacol. 1998 Dec;38(S1):55S-64S. doi: 10.1002/jcph.1998.38.s1.55.
Background: PubMed 22135737Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, Monroy-Maya R, Soto-Rios M, Carrillo-Alarcon L, Reyes-Garcia G, Fernandez-Martinez E. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.
Background: PubMed 12516888Curatolo M, Sveticic G. Drug combinations in pain treatment: a review of the published evidence and a method for finding the optimal combination. Best Pract Res Clin Anaesthesiol. 2002 Dec;16(4):507-19. doi: 10.1053/bean.2002.0254.
Background: PubMed 20037567Levin OS, Moseikin IA. [Vitamin B complex (milgamma) in the treatment of vertebrogenic lumbosacral radiculopathy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(10):30-5. Russian.
Background: PubMed 2138683Kuhlwein A, Meyer HJ, Koehler CO. [Reduced diclofenac administration by B vitamins: results of a randomized double-blind study with reduced daily doses of diclofenac (75 mg diclofenac versus 75 mg diclofenac plus B vitamins) in acute lumbar vertebral syndromes]. Klin Wochenschr. 1990 Jan 19;68(2):107-15. doi: 10.1007/BF01646857. German.
Background: PubMed 14699896Perez-Flores E, Medina-Santillan R, Reyes-Garcia G, Mateos-Garcia E. Combination of diclofenac plus B vitamins in acute pain after tonsillectomy: a pilot study. Proc West Pharmacol Soc. 2003;46:88-90. No abstract available.
Background: PubMed 19731994Mibielli MA, Geller M, Cohen JC, Goldberg SG, Cohen MT, Nunes CP, Oliveira LB, da Fonseca AS. Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study. Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.
Background: PubMed 11247324Gonzalez T, Balsa A, Sainz de Murieta J, Zamorano E, Gonzalez I, Martin-Mola E. Spanish version of the Northwick Park Neck Pain Questionnaire: reliability and validity. Clin Exp Rheumatol. 2001 Jan-Feb;19(1):41-6.
Background: PubMed 28540716Gaskell H, Derry S, Wiffen PJ, Moore RA. Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults. Cochrane Database Syst Rev. 2017 May 25;5(5):CD007355. doi: 10.1002/14651858.CD007355.pub3.
Individual participant dataSharing planned: No

Related trials for Acute Low Back Pain

Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
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Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
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Not yet recruiting
Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
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Recruiting
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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.

Pamela Delgado García, M.D principal investigator

IMACEN S.A. de C.V.,

Adelfia Urenda Quezada, M.D principal investigator

Mediadvance Clinical S.A.P.I. de C.V.

Ma. Dolores Alonso Martínez, M.D principal investigator

CICMEX Centro de Investigación Clínica de México

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 Dexketoprofen/Vitamin B and Dexketoprofen in people with Acute Low Back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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 6 inclusion and 20 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 Nov 2024. 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 Mexico. 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 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?

Changes in pain intensity (time frame: Baseline, 3, 5 and 7 days). The study lists 5 primary outcomes in all. 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 NCT05001555, which also lists 13 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 13 Nov 2024.