WhiplashNCT06389188
Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash
A study testing RHB Group in people with Whiplash, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Whiplash
- What is being tested?
- RHB Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 28 Oct 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18-60 years of age Who went to the emergency service after suffering a traffic car collision being the driver of the car.
- With acute WL grade II WAD diagnosis, made by physicians from the traumatology service (with neck pain by whiplash trauma with objective findings but no radiculopathy).
- Referred to the hospital rehabilitation service
Who cannot join
- Any other symptomatology different to neck pain and other coexisting medical conditions which could severely restrict participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cervical Osteopathic Manipulation Techniques of High Velocity and Low Amplitude in Patients With Whiplash- Associated Disorders
To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program.
Read the detailed description
A prospective, single-blind, parallel group, randomized, will be carried out in the physiotherapy service of the Clinic Hospital of Terrassa with the participation of the rehabilitation, radiology, traumatology and surgery services.
Patients will be recruited from emergency services of the Clinic Hospital of Terrassa and randomly divided into two groups MAN-Group and RHB-Group, using the random number generator of a statistical program (SPSS), to receive 3 and 20 treatment sessions, respectively.
The treatment protocol was carried out during four weeks, and both interventions occurred over the same time period. In both treatment groups, patients started sessions during the first two week after the traffic car collision.
MAN-Group were treated with cervical spine manipulation with SAT, after specialized physical therapists assessed there was no risk of vertebro-basilar injuries following the International Framework. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).
The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks. The exercises were performed five times (30 seconds interval each time) in a sitting position.
- Conditions
- Whiplash
- Being tested
- RHB Group
- Keywords
- manual therapy, manipulation, physical therapy, exercises
- Medical subject headings
- Whiplash Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHB GroupProcedure or surgery
The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: MAN Group | Experimental | MAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study). Receives: Procedure: RHB Group |
| MAN Group | Active comparator | MAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study). Receives: Procedure: RHB Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain intensity
Neck pain intensity was assessed with a Visual Analogue Scale (VAS) to measure the amount of pain experienced by a subject from both groups on a continuum from 0 to 100 mm. Scores can range from 0 (no pain) to 100 (worst imaginable pain)19,20. This method has been proven to be a reliable, generalizable and internally consistent measure of clinical and experimental neck pain
Measured: At baseline and at week 2, 4 and follow-up.
Neck specific disability
Neck-specific disability was measured with Neck Disability Index (NDI). The NDI is a valid measurement of disability in neck pain disorders. It is widely used and it has shown good reliability and validity in WAD studies. NDI scores can range from 0% (no limitation on activity) to 100% (worst possible disability).
Measured: At baseline and at week 2, 4 and follow-up.
Secondary outcomes (3)
Cervical range of motion (CROM)
Neck range of motion was tested with the CROM Instrument. All cervical motions and subsequent measurements were performed according to the manufacturer's specifications and were reproduced exactly for each trial with a single examiner performing all measurements. CROM were assessed in a relaxed sitting position, hips and knees positioned at 90º angles and buttocks positioned against the back of the chair. The goniometer was placed on the top of the head and was set in the neutral position.
Measured: At baseline and at week 2 and week 4.
Cervical lordosis Cobb angle
Cobb angle (COBB) method was measured to assess cervical lordosis (Cobb C2-C7) as the angle between the horizontal line on the lower endplate of C2 and a horizontal line on the lower endplate of C7. A clinically normal cervical lordosis has been described as a Cobb angle of 31-40 degrees, with subjects in standing and eyes focused straight ahead. A cervical lordosis of less than 20◦ from C2 to C7 has been shown to be related to cervical dysfunction and pain.
Measured: At baseline and at week 4.
Hospital anxiety and depression scale
HADS was used to determine the levels of anxiety and depression experienced by participants. HADS has 14 items and it was designed for the evaluation of anxiety and depression in non-psychiatric outpatient hospital services. The entire sum for both HADS anxiety and HADS depression levels ranges from 0 to 21. A score equal to or more than 10 indicates clinically significant symptoms of anxiety or depression.
Measured: At baseline and at week 4 and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 May 2024
- Primary completion5 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for WhiplashStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, JOSE VICENTE TOLEDO MARHUENDA, Universidad Miguel Hernandez de Elche
- Investigators
- Joan Parera-Turull, PhD., Principal investigator, Clinical Research Centre d'Osteopatia Terrassa. Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389188
- Sponsor's protocol ID
- JVT003
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen C, Stenager E, Nielsen CV. [Social, economic and cultural aspects of whiplash syndrome]. Ugeskr Laeger. 2010 Jun 14;172(24):1815-7. Danish.
PubMed 20566153Walton DM, Elliott JM. An Integrated Model of Chronic Whiplash-Associated Disorder. J Orthop Sports Phys Ther. 2017 Jul;47(7):462-471. doi: 10.2519/jospt.2017.7455. Epub 2017 Jun 16.
PubMed 28622487Spitzer 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 7604354Wiangkham T, Duda J, Haque S, Madi M, Rushton A. The Effectiveness of Conservative Management for Acute Whiplash Associated Disorder (WAD) II: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. PLoS One. 2015 Jul 21;10(7):e0133415. doi: 10.1371/journal.pone.0133415. eCollection 2015.
PubMed 261961277. Regal Ramos, R.J. Síndrome de latigazo cervical: Características epidemiológicas de los pacientes evaluados en la unidad médica de valoración de incapacidades de Madrid. Medicina y Seguridad del Trabajo 225:348-360 (2011).
Pajediene E, Janusauskaite J, Samusyte G, Stasaitis K, Petrikonis K, Bileviciute-Ljungar I. Patterns of acute whiplash-associated disorder in the Lithuanian population after road traffic accidents. J Rehabil Med. 2015 Jan;47(1):52-7. doi: 10.2340/16501977-1892.
PubMed 25315016Peolsson A, Landen Ludvigsson M, Peterson G. Neck-specific exercises with internet-based support compared to neck-specific exercises at a physiotherapy clinic for chronic whiplash-associated disorders: study protocol of a randomized controlled multicentre trial. BMC Musculoskelet Disord. 2017 Dec 12;18(1):524. doi: 10.1186/s12891-017-1853-1.
PubMed 29233141Peterson G, Dedering A, Andersson E, Nilsson D, Trygg J, Peolsson M, Wallman T, Peolsson A. Altered ventral neck muscle deformation for individuals with whiplash associated disorder compared to healthy controls - a case-control ultrasound study. Man Ther. 2015 Apr;20(2):319-27. doi: 10.1016/j.math.2014.10.006. Epub 2014 Oct 15.
PubMed 25454684Peolsson A, Karlsson A, Ghafouri B, Ebbers T, Engstrom M, Jonsson M, Wahlen K, Romu T, Borga M, Kristjansson E, Bahat HS, German D, Zsigmond P, Peterson G. Pathophysiology behind prolonged whiplash associated disorders: study protocol for an experimental study. BMC Musculoskelet Disord. 2019 Feb 2;20(1):51. doi: 10.1186/s12891-019-2433-3.
PubMed 30711003Elkin BS, Elliott JM, Siegmund GP. Whiplash Injury or Concussion? A Possible Biomechanical Explanation for Concussion Symptoms in Some Individuals Following a Rear-End Collision. J Orthop Sports Phys Ther. 2016 Oct;46(10):874-885. doi: 10.2519/jospt.2016.7049.
PubMed 27690834Church EW, Sieg EP, Zalatimo O, Hussain NS, Glantz M, Harbaugh RE. Systematic Review and Meta-analysis of Chiropractic Care and Cervical Artery Dissection: No Evidence for Causation. Cureus. 2016 Feb 16;8(2):e498. doi: 10.7759/cureus.498.
PubMed 27014532Haldeman S, Carroll L, Cassidy JD, Schubert J, Nygren A. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders: executive summary. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S7-9. doi: 10.1016/j.jmpt.2008.11.005. No abstract available.
PubMed 19251077Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL; COG. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010 Aug;15(4):315-33. doi: 10.1016/j.math.2010.04.002. Epub 2010 May 26.
PubMed 20510644Peolsson A, Landen Ludvigsson M, Tigerfors AM, Peterson G. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Feb;97(2):189-95. doi: 10.1016/j.apmr.2015.10.087. Epub 2015 Oct 26.
PubMed 26514296De Rosario H, Vivas MJ, Sinovas MI, Page A. Relationship between neck motion and self-reported pain in patients with whiplash associated disorders during the acute phase. Musculoskelet Sci Pract. 2018 Dec;38:23-29. doi: 10.1016/j.msksp.2018.09.004. Epub 2018 Sep 6.
PubMed 30218881
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Osteopathic Manipulation Techniques of High Velocity and Low Amplitude in Patients With Whiplash- Associated Disorders
- ClinicalTrials.gov ID
- NCT06389188
- Acronym / sponsor ID
- JVT003
- Conditions
- Whiplash
- Keywords
- manual therapy, manipulation, physical therapy, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Study start
- 1 May 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 29 Apr 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.
To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program.
Detailed description
A prospective, single-blind, parallel group, randomized, will be carried out in the physiotherapy service of the Clinic Hospital of Terrassa with the participation of the rehabilitation, radiology, traumatology and surgery services.
Patients will be recruited from emergency services of the Clinic Hospital of Terrassa and randomly divided into two groups MAN-Group and RHB-Group, using the random number generator of a statistical program (SPSS), to receive 3 and 20 treatment sessions, respectively.
The treatment protocol was carried out during four weeks, and both interventions occurred over the same time period. In both treatment groups, patients started sessions during the first two week after the traffic car collision.
MAN-Group were treated with cervical spine manipulation with SAT, after specialized physical therapists assessed there was no risk of vertebro-basilar injuries following the International Framework. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).
The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks. The exercises were performed five times (30 seconds interval each time) in a sitting position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: MAN Group | Experimental | Procedure: RHB GroupMAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study). |
| MAN Group | Active comparator | Procedure: RHB GroupMAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between 18-60 years of age Who went to the emergency service after suffering a traffic car collision being the driver of the car.
- With acute WL grade II WAD diagnosis, made by physicians from the traumatology service (with neck pain by whiplash trauma with objective findings but no radiculopathy).
- Referred to the hospital rehabilitation service
Key exclusion criteria (1 listed)
- Any other symptomatology different to neck pain and other coexisting medical conditions which could severely restrict participation in the study.
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 |
|---|---|---|
| RHB GroupThe RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks | Procedure or surgery | Experimental: MAN Group, MAN Group |
Primary outcome
Subjective pain intensity
Time frame: At baseline and at week 2, 4 and follow-up.
Neck pain intensity was assessed with a Visual Analogue Scale (VAS) to measure the amount of pain experienced by a subject from both groups on a continuum from 0 to 100 mm. Scores can range from 0 (no pain) to 100 (worst imaginable pain)19,20. This method has been proven to be a reliable, generalizable and internally consistent measure of clinical and experimental neck pain
Neck specific disability
Time frame: At baseline and at week 2, 4 and follow-up.
Neck-specific disability was measured with Neck Disability Index (NDI). The NDI is a valid measurement of disability in neck pain disorders. It is widely used and it has shown good reliability and validity in WAD studies. NDI scores can range from 0% (no limitation on activity) to 100% (worst possible disability).
3 secondary outcomes
Cervical range of motion (CROM)
Time frame: At baseline and at week 2 and week 4.
Cervical lordosis Cobb angle
Time frame: At baseline and at week 4.
Hospital anxiety and depression scale
Time frame: At baseline and at week 4 and follow-up.
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 7 Feb 2025.
- Background: PubMed 20566153Rasmussen C, Stenager E, Nielsen CV. [Social, economic and cultural aspects of whiplash syndrome]. Ugeskr Laeger. 2010 Jun 14;172(24):1815-7. Danish.
- Background: PubMed 28622487Walton DM, Elliott JM. An Integrated Model of Chronic Whiplash-Associated Disorder. J Orthop Sports Phys Ther. 2017 Jul;47(7):462-471. doi: 10.2519/jospt.2017.7455. Epub 2017 Jun 16.
- 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 26196127Wiangkham T, Duda J, Haque S, Madi M, Rushton A. The Effectiveness of Conservative Management for Acute Whiplash Associated Disorder (WAD) II: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. PLoS One. 2015 Jul 21;10(7):e0133415. doi: 10.1371/journal.pone.0133415. eCollection 2015.
- Background7. Regal Ramos, R.J. Síndrome de latigazo cervical: Características epidemiológicas de los pacientes evaluados en la unidad médica de valoración de incapacidades de Madrid. Medicina y Seguridad del Trabajo 225:348-360 (2011).
- Background: PubMed 25315016Pajediene E, Janusauskaite J, Samusyte G, Stasaitis K, Petrikonis K, Bileviciute-Ljungar I. Patterns of acute whiplash-associated disorder in the Lithuanian population after road traffic accidents. J Rehabil Med. 2015 Jan;47(1):52-7. doi: 10.2340/16501977-1892.
- Background: PubMed 29233141Peolsson A, Landen Ludvigsson M, Peterson G. Neck-specific exercises with internet-based support compared to neck-specific exercises at a physiotherapy clinic for chronic whiplash-associated disorders: study protocol of a randomized controlled multicentre trial. BMC Musculoskelet Disord. 2017 Dec 12;18(1):524. doi: 10.1186/s12891-017-1853-1.
- Background: PubMed 25454684Peterson G, Dedering A, Andersson E, Nilsson D, Trygg J, Peolsson M, Wallman T, Peolsson A. Altered ventral neck muscle deformation for individuals with whiplash associated disorder compared to healthy controls - a case-control ultrasound study. Man Ther. 2015 Apr;20(2):319-27. doi: 10.1016/j.math.2014.10.006. Epub 2014 Oct 15.
- Background: PubMed 30711003Peolsson A, Karlsson A, Ghafouri B, Ebbers T, Engstrom M, Jonsson M, Wahlen K, Romu T, Borga M, Kristjansson E, Bahat HS, German D, Zsigmond P, Peterson G. Pathophysiology behind prolonged whiplash associated disorders: study protocol for an experimental study. BMC Musculoskelet Disord. 2019 Feb 2;20(1):51. doi: 10.1186/s12891-019-2433-3.
- Background: PubMed 27690834Elkin BS, Elliott JM, Siegmund GP. Whiplash Injury or Concussion? A Possible Biomechanical Explanation for Concussion Symptoms in Some Individuals Following a Rear-End Collision. J Orthop Sports Phys Ther. 2016 Oct;46(10):874-885. doi: 10.2519/jospt.2016.7049.
- Background: PubMed 27014532Church EW, Sieg EP, Zalatimo O, Hussain NS, Glantz M, Harbaugh RE. Systematic Review and Meta-analysis of Chiropractic Care and Cervical Artery Dissection: No Evidence for Causation. Cureus. 2016 Feb 16;8(2):e498. doi: 10.7759/cureus.498.
- Background: PubMed 19251077Haldeman S, Carroll L, Cassidy JD, Schubert J, Nygren A. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders: executive summary. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S7-9. doi: 10.1016/j.jmpt.2008.11.005. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Whiplash
Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries
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.
Joan Parera-Turull, PhD. principal investigator
Clinical Research Centre d'Osteopatia Terrassa. Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHB Group in people with Whiplash, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 1 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 7 Feb 2025. 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 Spain. 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?
Subjective pain intensity (time frame: At baseline and at week 2, 4 and follow-up.). 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?
On the ClinicalTrials.gov record for NCT06389188, which also lists 15 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 7 Feb 2025.