Cervicogenic HeadacheNCT05865808
Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache.
A study testing cervical spine mobilization and Rocabado 6x6 in people with Cervicogenic Headache, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of this study is to investigate the effects of TMJ directed treatment approach using the Rocabado 6x6 program in patients with cervicogenic headache on the intensity of headache, function of the neck, and quality of life and compare its effectiveness with headache SNAGs which have been proven very… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- cervical spine mobilization and Rocabado 6x6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to 1 Aug 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-60 years.
- Unilateral headache that do not shift side with ipsilateral neck pain/stiffness.
- Headache for past 3 months at least once per week.
- Positive flexion rotation test.
Who cannot join
- Subjects with other type of headache.
- Specific disorders and congenital conditions of cervical spine.
- PT or chiropractic treatment in past 3 months.
- Severe pain, traumatic injury, occlusal splints or any surgery in TMJ area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache
The purpose of this study is to investigate the effects of TMJ directed treatment approach using the Rocabado 6x6 program in patients with cervicogenic headache on the intensity of headache, function of the neck, and quality of life and compare its effectiveness with headache SNAGs which have been proven very effective in treatment of cervicogenic headache.
Read the detailed description
The efectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache was evaluated. The research was conducted on five computerized databases PubMed/Medline, Web of Science, PEDro, Lilacs, and Cochrane Library (CENTRAL), using the keywords combination: (sustained natural apophyseal glide OR SNAG OR joint mobilization OR Mulligan) AND (cervicogenic headache) according to PRISMA guidelines. The methodological quality of the included studies was analyzed using the Physiotherapy Evidence Database (PEDro) scale. Eight articles fulflled the eligibility criteria and were included in the review. The selected studies had a methodological quality of 6.6/10 on the PEDro scale and included a total of 357 participants. The SNAG signifcantly improved pain, Flexion Rotation Test and reduced functional symptoms. Conclusion: The available evidence suggests that SNAG may be a relevant intervention for CH.
Effectiveness of different physiotherapy interventions in the management of cervicogenic headache was measured. Spinal mobilization, neural mobilization, and postural correction exercises techniques are physiotherapy interventions used for managing CGH symptoms. 80 participants with diagnosed CGH were recruited and divided into 4 groups. The spinal mobilization group received posteroanterior glide at the spinous and transverse process of C2 and C3 vertebra, lateral glide at affected side of the spinous process of C2 and C3 vertebra and translatoric glide at the transverse process of C1 vertebrae and SNAG. The neural mobilization group received neural mobilization of meninges, brachial plexus, and trigeminal nerve. In postural correction exercises group stretching of tight muscles (rectus capitus posterior, suboccipital, upper trapezeius, scalene, levator scapulae, sternocleidomastoid, pectoralis major/minor muscles) were given. Strengthening and endurance exercises for weak muscles (cervical flexors and deep cervical flexor, rhomboidus, and lower trapezeius muscles) were given. The control group was given normal range of motion exercises for the neck and shoulder region. It was concluded by results that applying any of the three modalities randomly in groups of patients with established CGH resulted in improvements of measured outcomes compared to a control group.
Limited literature is available about TMJ treatment in patients with headaches, and few studies has applied direct interventions to the muscles involved in TMJ movement to relieve headache symptoms. Due to the methodological shortcomings, diversity of interventions and inconsistency of findings, there is currently low certainty that there is an effect of physical therapy for TMJ on concomitant headache intensity compared to control interventions. More studies of higher methodological quality are needed so better conclusions could be taken.Further, till now very few studies have done to prove the effect of Rocabado's approach and neither a single study conducted on its effectiveness for headache.
- Conditions
- Cervicogenic Headache
- Being tested
- cervical spine mobilization, Rocabado 6x6
- Keywords
- cervical spine, neurological disorder, post-traumatic disorder, secondary headache
- Medical subject headings
- Post-Traumatic Headache, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical spine mobilizationOther
headache SNAGs, 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Eight weeks of treatment session will be provided and assessment of the improvement in cervicogenic headache will done at baseline, after 04, 06 and at the end of 8 week.
Rocabado 6x6Other
The Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique, which are to be performed 6 times in a day with 6 repetitions of each exercise in each session,
| Study group | Role | What they receive |
|---|---|---|
| Cervical spine mobilization | Experimental | Subjects in this group will be treated with headache SNAGs Receives: Other: cervical spine mobilization |
| Rocabado 6x6 exercises | Active comparator | Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique. Receives: Other: Rocabado 6x6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Neck Disability Index will be used examine neck pain intensity and cervicogenic headache symptoms.Consists of 10 sections each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.
Changes from Baseline to 8 weeks.
Measured: 8th week
Secondary outcomes (3)
Headache Impact Test-6 SCALE
The 6-item Headache Impact Test scale will be used to examine headache severity and its adverse effects on social life and functions. Consists of 6 sections that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent Changes from Baseline to 8 weeks.
Measured: 8th week
Flexion Rotation Test
Flexion-Rotation Test to assess rotation range of motion at the level of C1-C2 and confirmed by a cervical range of motion device/goniometer. The reported normal range of rotation during the FRT is 44° to each side and is positive if mobility is restricted by more than 10° or if symptoms occur during the procedure.
Changes from Baseline to 8 weeks.
Measured: 8th week
Numeric Pain Rating Scale
The numeric pain rating scale for the intensity of pain ranges from 0-10. Zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Changes from Baseline to 8 weeks.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 May 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 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 Cervicogenic HeadacheStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865808
- Sponsor's protocol ID
- REC/RCR & AHS/23/0121
- Status last verified
- Dec 2023
- First submitted
- 4 May 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paquin JP, Tousignant-Laflamme Y, Dumas JP. Effects of SNAG mobilization combined with a self-SNAG home-exercise for the treatment of cervicogenic headache: a pilot study. J Man Manip Ther. 2021 Aug;29(4):244-254. doi: 10.1080/10669817.2020.1864960. Epub 2021 Feb 5.
PubMed 33541242Verma S, Tripathi M, Chandra PS. Cervicogenic Headache: Current Perspectives. Neurol India. 2021 Mar-Apr;69(Supplement):S194-S198. doi: 10.4103/0028-3886.315992.
PubMed 34003165Cardoso R, Seixas A, Rodrigues S, Moreira-Silva I, Ventura N, Azevedo J, Monsignori F. The effectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache: A Systematic Review of Randomized Trials. Arch Physiother. 2022 Sep 1;12(1):20. doi: 10.1186/s40945-022-00144-3.
PubMed 36045409Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.
PubMed 34374330Coskun Benlidayi I MD, Guzel R MD, Tatli U PhD, Salimov F PhD, Keceli O PhD. The relationship between neck pain and cervical alignment in patients with temporomandibular disorders. Cranio. 2020 May;38(3):174-179. doi: 10.1080/08869634.2018.1498181. Epub 2018 Jul 26.
PubMed 30048225Ghodrati M, Mosallanezhad Z, Shati M, Noroozi M, Moghadam AN, Rostami M, Nourbakhsh MR. Adding Temporomandibular joint treatments to routine physiotherapy for patients with non-specific chronic neck pain: A randomized clinical study. J Bodyw Mov Ther. 2020 Apr;24(2):202-212. doi: 10.1016/j.jbmt.2019.11.004. Epub 2019 Nov 22.
PubMed 32507146Kang JH. Effects on migraine, neck pain, and head and neck posture, of temporomandibular disorder treatment: Study of a retrospective cohort. Arch Oral Biol. 2020 Jun;114:104718. doi: 10.1016/j.archoralbio.2020.104718. Epub 2020 Apr 18.
PubMed 32334135Greenbaum T, Dvir Z, Emodi-Perlman A, Reiter S, Rubin P, Winocur E. The association between specific temporomandibular disorders and cervicogenic headache. Musculoskelet Sci Pract. 2021 Apr;52:102321. doi: 10.1016/j.msksp.2021.102321. Epub 2021 Jan 12.
PubMed 33482538Craciun MD, Geman O, Leuciuc FV, Holubiac IS, Gheorghita D, Filip F. Effectiveness of Physiotherapy in the Treatment of Temporomandibular Joint Dysfunction and the Relationship with Cervical Spine. Biomedicines. 2022 Nov 17;10(11):2962. doi: 10.3390/biomedicines10112962.
PubMed 36428529Pundkar S, Patil D, Naqvi W. A Comparative Study on Effectiveness of Rocabado Approach and Conventional Physiotherapy on Pain, ROM and QOL in Patients with TMJ Dysfunction. 2021.
Corum M. Evaluation of Cervical Dysfunctions in Temporomandibular Disorders. Medical Journal of Bakirkoy. 2021;17(1).
La Touche R, Martinez Garcia S, Serrano Garcia B, Proy Acosta A, Adraos Juarez D, Fernandez Perez JJ, Angulo-Diaz-Parreno S, Cuenca-Martinez F, Paris-Alemany A, Suso-Marti L. Effect of Manual Therapy and Therapeutic Exercise Applied to the Cervical Region on Pain and Pressure Pain Sensitivity in Patients with Temporomandibular Disorders: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2373-2384. doi: 10.1093/pm/pnaa021.
PubMed 32181811Murtza S, Noor R, Bashir MS, Ikram M. Effects of sustained natural apophyseal glides versus rocabado 6 x 6 program in subjects with cervicogenic headache. BMC Musculoskelet Disord. 2024 Feb 22;25(1):169. doi: 10.1186/s12891-024-07290-8.
PubMed 38389050
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustained Natural Appophyseal Glide Versus Rocababo 6x6 Program in Subjects With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05865808
- Acronym / sponsor ID
- REC/RCR & AHS/23/0121
- Conditions
- Cervicogenic Headache
- Keywords
- cervical spine, neurological disorder, post-traumatic disorder, secondary headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 19 May 2023 (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.
The purpose of this study is to investigate the effects of TMJ directed treatment approach using the Rocabado 6x6 program in patients with cervicogenic headache on the intensity of headache, function of the neck, and quality of life and compare its effectiveness with headache SNAGs which have been proven very effective in treatment of cervicogenic headache.
Detailed description
The efectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache was evaluated. The research was conducted on five computerized databases PubMed/Medline, Web of Science, PEDro, Lilacs, and Cochrane Library (CENTRAL), using the keywords combination: (sustained natural apophyseal glide OR SNAG OR joint mobilization OR Mulligan) AND (cervicogenic headache) according to PRISMA guidelines. The methodological quality of the included studies was analyzed using the Physiotherapy Evidence Database (PEDro) scale. Eight articles fulflled the eligibility criteria and were included in the review. The selected studies had a methodological quality of 6.6/10 on the PEDro scale and included a total of 357 participants. The SNAG signifcantly improved pain, Flexion Rotation Test and reduced functional symptoms. Conclusion: The available evidence suggests that SNAG may be a relevant intervention for CH.
Effectiveness of different physiotherapy interventions in the management of cervicogenic headache was measured. Spinal mobilization, neural mobilization, and postural correction exercises techniques are physiotherapy interventions used for managing CGH symptoms. 80 participants with diagnosed CGH were recruited and divided into 4 groups. The spinal mobilization group received posteroanterior glide at the spinous and transverse process of C2 and C3 vertebra, lateral glide at affected side of the spinous process of C2 and C3 vertebra and translatoric glide at the transverse process of C1 vertebrae and SNAG. The neural mobilization group received neural mobilization of meninges, brachial plexus, and trigeminal nerve. In postural correction exercises group stretching of tight muscles (rectus capitus posterior, suboccipital, upper trapezeius, scalene, levator scapulae, sternocleidomastoid, pectoralis major/minor muscles) were given. Strengthening and endurance exercises for weak muscles (cervical flexors and deep cervical flexor, rhomboidus, and lower trapezeius muscles) were given. The control group was given normal range of motion exercises for the neck and shoulder region. It was concluded by results that applying any of the three modalities randomly in groups of patients with established CGH resulted in improvements of measured outcomes compared to a control group.
Limited literature is available about TMJ treatment in patients with headaches, and few studies has applied direct interventions to the muscles involved in TMJ movement to relieve headache symptoms. Due to the methodological shortcomings, diversity of interventions and inconsistency of findings, there is currently low certainty that there is an effect of physical therapy for TMJ on concomitant headache intensity compared to control interventions. More studies of higher methodological quality are needed so better conclusions could be taken.Further, till now very few studies have done to prove the effect of Rocabado's approach and neither a single study conducted on its effectiveness for headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical spine mobilization | Experimental | Other: cervical spine mobilizationSubjects in this group will be treated with headache SNAGs |
| Rocabado 6x6 exercises | Active comparator | Other: Rocabado 6x6Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-60 years.
- Unilateral headache that do not shift side with ipsilateral neck pain/stiffness.
- Headache for past 3 months at least once per week.
- Positive flexion rotation test.
Key exclusion criteria (4 listed)
- Subjects with other type of headache.
- Specific disorders and congenital conditions of cervical spine.
- PT or chiropractic treatment in past 3 months.
- Severe pain, traumatic injury, occlusal splints or any surgery in TMJ area
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 |
|---|---|---|
| cervical spine mobilizationheadache SNAGs, 10 repetitions holding for 10 seconds in each glide with a rest time of 30 seconds in between. Eight weeks of treatment session will be provided and assessment of the improvement in cervicogenic headache will done at baseline, after 04, 06 and at the end of 8 week. | Other | Cervical spine mobilization |
| Rocabado 6x6The Rocabado 6x6 program includes 6 types of exercises which are- rest position of the tongue, TMJ rotation control, upper cervical distraction, axial extension of cervical spine, shoulder girdle retraction, and rhythmic stabilization technique, which are to be performed 6 times in a day with 6 repetitions of each exercise in each session, | Other | Rocabado 6x6 exercises |
Primary outcome
Neck Disability Index
Time frame: 8th week
Neck Disability Index will be used examine neck pain intensity and cervicogenic headache symptoms.Consists of 10 sections each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Changes from Baseline to 8 weeks.
3 secondary outcomes
Headache Impact Test-6 SCALE
Time frame: 8th week
Flexion Rotation Test
Time frame: 8th week
Numeric Pain Rating Scale
Time frame: 8th 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 27 Dec 2023.
- Background: PubMed 33541242Paquin JP, Tousignant-Laflamme Y, Dumas JP. Effects of SNAG mobilization combined with a self-SNAG home-exercise for the treatment of cervicogenic headache: a pilot study. J Man Manip Ther. 2021 Aug;29(4):244-254. doi: 10.1080/10669817.2020.1864960. Epub 2021 Feb 5.
- Background: PubMed 34003165Verma S, Tripathi M, Chandra PS. Cervicogenic Headache: Current Perspectives. Neurol India. 2021 Mar-Apr;69(Supplement):S194-S198. doi: 10.4103/0028-3886.315992.
- Background: PubMed 36045409Cardoso R, Seixas A, Rodrigues S, Moreira-Silva I, Ventura N, Azevedo J, Monsignori F. The effectiveness of Sustained Natural Apophyseal Glide on Flexion Rotation Test, pain intensity, and functionality in subjects with Cervicogenic Headache: A Systematic Review of Randomized Trials. Arch Physiother. 2022 Sep 1;12(1):20. doi: 10.1186/s40945-022-00144-3.
- Background: PubMed 34374330Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.
- Background: PubMed 30048225Coskun Benlidayi I MD, Guzel R MD, Tatli U PhD, Salimov F PhD, Keceli O PhD. The relationship between neck pain and cervical alignment in patients with temporomandibular disorders. Cranio. 2020 May;38(3):174-179. doi: 10.1080/08869634.2018.1498181. Epub 2018 Jul 26.
- Background: PubMed 32507146Ghodrati M, Mosallanezhad Z, Shati M, Noroozi M, Moghadam AN, Rostami M, Nourbakhsh MR. Adding Temporomandibular joint treatments to routine physiotherapy for patients with non-specific chronic neck pain: A randomized clinical study. J Bodyw Mov Ther. 2020 Apr;24(2):202-212. doi: 10.1016/j.jbmt.2019.11.004. Epub 2019 Nov 22.
- Background: PubMed 32334135Kang JH. Effects on migraine, neck pain, and head and neck posture, of temporomandibular disorder treatment: Study of a retrospective cohort. Arch Oral Biol. 2020 Jun;114:104718. doi: 10.1016/j.archoralbio.2020.104718. Epub 2020 Apr 18.
- Background: PubMed 33482538Greenbaum T, Dvir Z, Emodi-Perlman A, Reiter S, Rubin P, Winocur E. The association between specific temporomandibular disorders and cervicogenic headache. Musculoskelet Sci Pract. 2021 Apr;52:102321. doi: 10.1016/j.msksp.2021.102321. Epub 2021 Jan 12.
- Background: PubMed 36428529Craciun MD, Geman O, Leuciuc FV, Holubiac IS, Gheorghita D, Filip F. Effectiveness of Physiotherapy in the Treatment of Temporomandibular Joint Dysfunction and the Relationship with Cervical Spine. Biomedicines. 2022 Nov 17;10(11):2962. doi: 10.3390/biomedicines10112962.
- BackgroundPundkar S, Patil D, Naqvi W. A Comparative Study on Effectiveness of Rocabado Approach and Conventional Physiotherapy on Pain, ROM and QOL in Patients with TMJ Dysfunction. 2021.
- BackgroundCorum M. Evaluation of Cervical Dysfunctions in Temporomandibular Disorders. Medical Journal of Bakirkoy. 2021;17(1).
- Background: PubMed 32181811La Touche R, Martinez Garcia S, Serrano Garcia B, Proy Acosta A, Adraos Juarez D, Fernandez Perez JJ, Angulo-Diaz-Parreno S, Cuenca-Martinez F, Paris-Alemany A, Suso-Marti L. Effect of Manual Therapy and Therapeutic Exercise Applied to the Cervical Region on Pain and Pressure Pain Sensitivity in Patients with Temporomandibular Disorders: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2373-2384. doi: 10.1093/pm/pnaa021.
- 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.
Rabiya Noor, phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical spine mobilization and Rocabado 6x6 in people with Cervicogenic Headache, 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 4 inclusion and 4 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 27 Dec 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?
Neck Disability Index (time frame: 8th week). 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 NCT05865808, 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 27 Dec 2023.