Temporomandibular DysfunctionNCT05618938
Effects of Rocabado's Approach Versus Kraus Exercise Therapy
A study testing Rocabado's approach and Kraus exercises in people with Temporomandibular Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Temporomandibular Dysfunction
- What is being tested?
- Rocabado's approach and Kraus exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Nov 2022to 4 Feb 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female between the ages of 30 to 60 years
- Patients with jaw pain
- Patients with limited jaw range of motion and associated joint pain
- Patients with TMJ clicking sounds
- Patients with pain upon muscle and joint palpation
Who cannot join
- Diagnosis of ear, nose, and throat medical pathology underlying the tinnitus;
- Neurological problems that could potentially cause the tinnitus
- Inability to read, understand, and complete the questionnaires or understand and follow commands (e.g., illiteracy, dementia, or blindness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rocabado's Approach Versus Kraus Exercise Therapy on Pain and Disability in Patients With Temporomandibular Dysfunction
TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Temporomandibular joint disorders are a type of craniofacial problems. They affect the temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus therapy on Pain and Disability in patients with temporomandibular dysfunction.
Read the detailed description
A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using random sampling through opaque sealed enveloped into Group A and Group B. Group A will be treated with Rocabado's approach and Group B will be treated with Kraus exercises. Outcome measures tools will be conducted through NPRS, TMD disability index, Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Temporomandibular Dysfunction
- Being tested
- Rocabado's approach, Kraus exercises
- Keywords
- Rocabado's Approach, Kraus exercises, Disability
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocabado's approachOther
Group A will be treated with Rocabado's approach. Rocabado' approach will be comprised of six exercises.
- Rest position of the tongue
- Control of TMJ rotation
- Rhythmic stabilization technique
- Axial extension of the neck The patients will receive Rocabado's approach consisting 6 repetitions six times a day thrice per week for four weeks
Kraus exercisesOther
Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs.
- Tongue position at rest
- Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position
- Nasal-diaphragmatic breathing
- Tongue up and wiggle
- Strengthening
- Touch and bite: Proprioceptive re-education: Lateral deviation The patients will receive Kraus exercises with the frequency of 2 sets and 10 repetitions twice a day three times per week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Group: A Rocabado's approach | Experimental | 1. Rest position of the tongue: The anterior 1/3 of the tongue is placed at the palate with mild pressure.
2. Control of TMJ rotation: The jaw is repeatedly opened and closed with the anterior 1/3 of the tongue on the palate.
3. Rhythmic stabilization technique: Gentle isometrics in the resting position are performed for jaw opening, closing, and lateral deviation.
4. Axial extension of the neck: Combined upper cervical flexion with lower cervical extension. Receives: Other: Rocabado's approach |
| Group B: Kraus exercises | Experimental | Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs.
1. Tongue position at rest: The patient will be instructed to maintain a resting tongue position except during function, which involves the tip of the tongue sitting on the palate with the tip resting just posterior to the upper incisors
2. Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position
3. Nasal-diaphragmatic breathing: The patient will be instructed in nasal breathing to facilitate function of the diaphragm, which reinforces positioning of both the tongue and teeth
4. Tongue up and wiggle: Place the tongue to the palate, then move the jaw from side to side.
5. Strengthening: Resisted closing via self-manual resistance using tongue depressor between lower incisors: 5-10-second contractions. Receives: Other: Kraus exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
pre and post followup on 4th week
Measured: 4th week
Temporomandibular Joint Disability Index Questionnaire:
The TMD Disability Index is a ten-question questionnaire that is based on the Oswestry Back Pain Questionnaire and the Neck Pain and Disability Questionnaire. 12 It is TMJ-specific, comprising specialized TMJ tasks (instrument playing, speech, dental care, and so on); it delivers a score ranging from 20 to 100.
pre and post followup on 4th week
Measured: 4th week
Fonseca's Questionnaire for severity
TMD diseases are classified using the Fonseca questionnaire into mild, moderate, severe, or no disease. It consists of ten questions about temporomandibular joint pain, head, back, and chewing discomfort, parafunctional habits, movement limits, joint clicking, perception of malocclusion, and emotional stress sensation.
pre and post followup on 4th week
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start4 Nov 2022
- Primary completion4 Feb 2023
- Study completion4 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618938
- Sponsor's protocol ID
- REC/RCR & AHS/22/0151 Amna
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scrivani SJ, Khawaja SN, Bavia PF. Nonsurgical Management of Pediatric Temporomandibular Joint Dysfunction. Oral Maxillofac Surg Clin North Am. 2018 Feb;30(1):35-45. doi: 10.1016/j.coms.2017.08.001.
PubMed 29153236Matsubara R, Yanagi Y, Oki K, Hisatomi M, Santos KC, Bamgbose BO, Fujita M, Okada S, Minagi S, Asaumi J. Assessment of MRI findings and clinical symptoms in patients with temporomandibular joint disorders. Dentomaxillofac Radiol. 2018 May;47(4):20170412. doi: 10.1259/dmfr.20170412. Epub 2018 Feb 22.
PubMed 29451403Dimitroulis G. Temporomandibular joint surgery: what does it mean to the dental practitioner? Aust Dent J. 2011 Sep;56(3):257-64. doi: 10.1111/j.1834-7819.2011.01351.x.
PubMed 21884140Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Slade GD, Bair E, Greenspan JD, Dubner R, Fillingim RB, Diatchenko L, Maixner W, Knott C, Ohrbach R. Signs and symptoms of first-onset TMD and sociodemographic predictors of its development: the OPPERA prospective cohort study. J Pain. 2013 Dec;14(12 Suppl):T20-32.e1-3. doi: 10.1016/j.jpain.2013.07.014.
PubMed 24275221Yadav S, Yang Y, Dutra EH, Robinson JL, Wadhwa S. Temporomandibular Joint Disorders in Older Adults. J Am Geriatr Soc. 2018 Jul;66(6):1213-1217. doi: 10.1111/jgs.15354. Epub 2018 May 2.
PubMed 29719041Lora VR, Canales Gde L, Goncalves LM, Meloto CB, Barbosa CM. Prevalence of temporomandibular disorders in postmenopausal women and relationship with pain and HRT. Braz Oral Res. 2016 Aug 22;30(1):e100. doi: 10.1590/1807-3107BOR-2016.vol30.0100.
PubMed 27556676Ernst M, Schenkenberger AE, Domin M, Kordass B, Lotze M. Effects of centric mandibular splint therapy on orofacial pain and cerebral activation patterns. Clin Oral Investig. 2020 Jun;24(6):2005-2013. doi: 10.1007/s00784-019-03064-y. Epub 2019 Sep 13.
PubMed 31520181Seifi M, Ebadifar A, Kabiri S, Badiee MR, Abdolazimi Z, Amdjadi P. Comparative effectiveness of Low Level Laser therapy and Transcutaneous Electric Nerve Stimulation on Temporomandibular Joint Disorders. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S27-S31. doi: 10.15171/jlms.2017.s6. Epub 2017 Aug 29.
PubMed 29071032Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488.
PubMed 29924769
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rocabado's Approach Versus Kraus Exercise Therapy on Pain and Disability in Patients With Temporomandibular Dysfunction
- ClinicalTrials.gov ID
- NCT05618938
- Acronym / sponsor ID
- REC/RCR & AHS/22/0151 Amna
- Conditions
- Temporomandibular Dysfunction
- Keywords
- Rocabado's Approach, Kraus exercises, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 4 Feb 2023 (actual)
- First posted
- 16 Nov 2022 (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.
TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Temporomandibular joint disorders are a type of craniofacial problems. They affect the temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus therapy on Pain and Disability in patients with temporomandibular dysfunction.
Detailed description
A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using random sampling through opaque sealed enveloped into Group A and Group B. Group A will be treated with Rocabado's approach and Group B will be treated with Kraus exercises. Outcome measures tools will be conducted through NPRS, TMD disability index, Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group: A Rocabado's approach | Experimental | Other: Rocabado's approach1. Rest position of the tongue: The anterior 1/3 of the tongue is placed at the palate with mild pressure. 2. Control of TMJ rotation: The jaw is repeatedly opened and closed with the anterior 1/3 of the tongue on the palate. 3. Rhythmic stabilization technique: Gentle isometrics in the resting position are performed for jaw opening, closing, and lateral deviation. 4. Axial extension of the neck: Combined upper cervical flexion with lower cervical extension. |
| Group B: Kraus exercises | Experimental | Other: Kraus exercisesGroup B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs. 1. Tongue position at rest: The patient will be instructed to maintain a resting tongue position except during function, which involves the tip of the tongue sitting on the palate with the tip resting just posterior to the upper incisors 2. Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position 3. Nasal-diaphragmatic breathing: The patient will be instructed in nasal breathing to facilitate function of the diaphragm, which reinforces positioning of both the tongue and teeth 4. Tongue up and wiggle: Place the tongue to the palate, then move the jaw from side to side. 5. Strengthening: Resisted closing via self-manual resistance using tongue depressor between lower incisors: 5-10-second contractions. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female between the ages of 30 to 60 years
- Patients with jaw pain
- Patients with limited jaw range of motion and associated joint pain
- Patients with TMJ clicking sounds
- Patients with pain upon muscle and joint palpation
Key exclusion criteria (3 listed)
- Diagnosis of ear, nose, and throat medical pathology underlying the tinnitus;
- Neurological problems that could potentially cause the tinnitus
- Inability to read, understand, and complete the questionnaires or understand and follow commands (e.g., illiteracy, dementia, or blindness)
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 |
|---|---|---|
| Rocabado's approachGroup A will be treated with Rocabado's approach. Rocabado' approach will be comprised of six exercises. 1. Rest position of the tongue 2. Control of TMJ rotation 3. Rhythmic stabilization technique 4. Axial extension of the neck The patients will receive Rocabado's approach consisting 6 repetitions six times a day thrice per week for four weeks | Other | Group: A Rocabado's approach |
| Kraus exercisesGroup B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs. 1. Tongue position at rest 2. Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position 3. Nasal-diaphragmatic breathing 4. Tongue up and wiggle 5. Strengthening 6. Touch and bite: Proprioceptive re-education: Lateral deviation The patients will receive Kraus exercises with the frequency of 2 sets and 10 repetitions twice a day three times per week for four weeks | Other | Group B: Kraus exercises |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain. pre and post followup on 4th week
Temporomandibular Joint Disability Index Questionnaire:
Time frame: 4th week
The TMD Disability Index is a ten-question questionnaire that is based on the Oswestry Back Pain Questionnaire and the Neck Pain and Disability Questionnaire. 12 It is TMJ-specific, comprising specialized TMJ tasks (instrument playing, speech, dental care, and so on); it delivers a score ranging from 20 to 100. pre and post followup on 4th week
Fonseca's Questionnaire for severity
Time frame: 4th week
TMD diseases are classified using the Fonseca questionnaire into mild, moderate, severe, or no disease. It consists of ten questions about temporomandibular joint pain, head, back, and chewing discomfort, parafunctional habits, movement limits, joint clicking, perception of malocclusion, and emotional stress sensation. pre and post followup on 4th week
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 19 Apr 2023.
- Background: PubMed 29153236Scrivani SJ, Khawaja SN, Bavia PF. Nonsurgical Management of Pediatric Temporomandibular Joint Dysfunction. Oral Maxillofac Surg Clin North Am. 2018 Feb;30(1):35-45. doi: 10.1016/j.coms.2017.08.001.
- Background: PubMed 29451403Matsubara R, Yanagi Y, Oki K, Hisatomi M, Santos KC, Bamgbose BO, Fujita M, Okada S, Minagi S, Asaumi J. Assessment of MRI findings and clinical symptoms in patients with temporomandibular joint disorders. Dentomaxillofac Radiol. 2018 May;47(4):20170412. doi: 10.1259/dmfr.20170412. Epub 2018 Feb 22.
- Background: PubMed 21884140Dimitroulis G. Temporomandibular joint surgery: what does it mean to the dental practitioner? Aust Dent J. 2011 Sep;56(3):257-64. doi: 10.1111/j.1834-7819.2011.01351.x.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 24275221Slade GD, Bair E, Greenspan JD, Dubner R, Fillingim RB, Diatchenko L, Maixner W, Knott C, Ohrbach R. Signs and symptoms of first-onset TMD and sociodemographic predictors of its development: the OPPERA prospective cohort study. J Pain. 2013 Dec;14(12 Suppl):T20-32.e1-3. doi: 10.1016/j.jpain.2013.07.014.
- Background: PubMed 29719041Yadav S, Yang Y, Dutra EH, Robinson JL, Wadhwa S. Temporomandibular Joint Disorders in Older Adults. J Am Geriatr Soc. 2018 Jul;66(6):1213-1217. doi: 10.1111/jgs.15354. Epub 2018 May 2.
- Background: PubMed 27556676Lora VR, Canales Gde L, Goncalves LM, Meloto CB, Barbosa CM. Prevalence of temporomandibular disorders in postmenopausal women and relationship with pain and HRT. Braz Oral Res. 2016 Aug 22;30(1):e100. doi: 10.1590/1807-3107BOR-2016.vol30.0100.
- Background: PubMed 31520181Ernst M, Schenkenberger AE, Domin M, Kordass B, Lotze M. Effects of centric mandibular splint therapy on orofacial pain and cerebral activation patterns. Clin Oral Investig. 2020 Jun;24(6):2005-2013. doi: 10.1007/s00784-019-03064-y. Epub 2019 Sep 13.
- Background: PubMed 29071032Seifi M, Ebadifar A, Kabiri S, Badiee MR, Abdolazimi Z, Amdjadi P. Comparative effectiveness of Low Level Laser therapy and Transcutaneous Electric Nerve Stimulation on Temporomandibular Joint Disorders. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S27-S31. doi: 10.15171/jlms.2017.s6. Epub 2017 Aug 29.
- Background: PubMed 29924769Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488.
- 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.
Samrood Akram, Mphil principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocabado's approach and Kraus exercises in people with Temporomandibular Dysfunction, run by Riphah International University at 1 site in Pakistan.
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 3 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 19 Apr 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 Pakistan. 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?
Numeric Pain Rating Scale (NPRS) (time frame: 4th week). The study lists 3 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 NCT05618938, which also lists 10 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 19 Apr 2023.