Cervicogenic HeadacheNCT07796711
Baseline Cervical Joint Position Error and Headache Intensity
An observational study of Cervicogenic Headache and Cervicogenic Headaches, run by Saveetha University at 1 site in India.
Trial summary
Cervicogenic headache is a type of headache associated with problems or dysfunction in the neck. People with cervicogenic headache may experience headache pain along with neck pain, reduced neck movement, and difficulties with normal neck function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache, Cervicogenic Headaches
- What is being tested?
- Routine clinician-directed physiotherapy
- How many people
- 126 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2025to 20 Oct 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective observational cohort comprised adults aged 18-65 years who were clinically classified with cervicogenic headache and received routine clinician-directed physiotherapy at the outpatient physiotherapy department of Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS), Chennai, Tamil Nadu, India. Clinical records from January 2023 to December 2025 were reviewed. Participants had baseline cervical joint position error and headache intensity documented before physiotherapy and completed at least four physiotherapy sessions with a treatment-completion outcome assessment. Of 172 records identified, 46 were excluded after applying eligibility criteria, resulting in a final analytical cohort of 126 patients.
Who may be able to join
- Adults aged 18-65 years.
- Clinically classified with cervicogenic headache (CGH) based on the retrospective classification rule derived from the Cervicogenic Headache
- International Study Group criteria.
- At least 3 of the 5 documented CGH features were present.
- Baseline cervical joint position error (JPE) was measured before physiotherapy.
- Baseline headache intensity (NPRS) was documented.
Show all 9Show fewer
- Completed at least 4 physiotherapy sessions.
- Had at least one treatment-completion outcome assessment.
- Clinical records contained sufficiently complete baseline and outcome information.
Who cannot join
- History of cervical spine surgery.
- Cervical trauma or whiplash within the previous 6 months.
- Cervical fracture, instability, or severe structural pathology.
- Rheumatoid or other inflammatory cervical disease.
- Neurological disorders affecting cervical sensorimotor function.
- Vestibular disorders affecting JPE testing.
Show all 9Show fewer
- Migraine or another primary headache disorder as the predominant diagnosis.
- Systemic malignancy affecting the cervical region.
- Incomplete baseline JPE or treatment-completion outcome data.
Trial locations and contacts
1 site in 1 country.
India1 site
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS)
Chennai, Tamil Nadu, 602105
About this study
Official title: Baseline Cervical Joint Position Error and Headache Intensity at Treatment Completion in Adults Clinically Classified With Cervicogenic Headache: A Retrospective Cohort Study
Cervicogenic headache is a type of headache associated with problems or dysfunction in the neck. People with cervicogenic headache may experience headache pain along with neck pain, reduced neck movement, and difficulties with normal neck function. Cervical joint position error (JPE) is a measure of how accurately a person can return their head to its starting position after moving the neck. A greater JPE may indicate reduced accuracy of neck position sense.
The purpose of this retrospective study is to determine whether the amount of cervical JPE measured before physiotherapy is associated with headache intensity at the completion of physiotherapy in adults clinically classified with cervicogenic headache. The study will also examine whether baseline cervical JPE is associated with achieving a meaningful reduction in headache intensity.
Read more
The study will use existing clinical records of adults aged 18 to 65 years who were clinically classified with cervicogenic headache and received routine physiotherapy at a university teaching hospital. Records from January 2023 to December 2025 will be reviewed. Participants must have had cervical JPE and headache intensity recorded before physiotherapy and must have completed at least four physiotherapy sessions with a treatment-completion assessment.
Cervical JPE will be assessed from the recorded baseline measurements obtained using a CROM (Cervical Range of Motion) device. Headache intensity will be assessed using the Numeric Pain Rating Scale (NPRS), where 0 represents no pain and 10 represents the worst imaginable pain. The primary outcome will be headache intensity recorded at the treatment-completion assessment.
The study will compare baseline cervical JPE with treatment-completion headache intensity while taking into account other relevant factors, including baseline headache intensity, neck disability, age, and sex. The study will also examine whether participants achieved a reduction of at least 2 points on the NPRS during the observed treatment period.
As this is a retrospective observational study, the researchers will not assign or change participants' treatment. The study will use information already available in clinical records and will not require participants to receive additional treatment or undergo additional assessments. The study is intended to determine whether baseline cervical JPE may be associated with subsequent headache outcomes and whether it may be useful as a potential prognostic factor. It will not determine whether cervical JPE causes headache or whether JPE should be used to select a particular physiotherapy treatment.
The findings may help guide future research on factors that are associated with treatment outcomes in people with cervicogenic headache. Further prospective studies may be needed to determine whether cervical JPE has useful prognostic value at the individual patient level.
Read the detailed description
Cervicogenic headache (CGH) is a secondary headache disorder associated with cervical musculoskeletal dysfunction. Clinical features may include unilateral headache, headache provoked by neck movement or sustained cervical postures, restricted cervical range of motion, neck or shoulder pain, and evidence of cervical musculoskeletal dysfunction. Physiotherapy is commonly used in the management of CGH; however, outcomes following physiotherapy may vary between individuals.
Cervical joint position error (JPE) is a measure of cervical sensorimotor accuracy. It assesses the ability of an individual to accurately return the head to a previously established starting position following active cervical movement. Increased JPE may reflect impaired cervical proprioception or sensorimotor control. Although elevated cervical JPE has been reported in individuals with neck pain and CGH, its potential prognostic relevance for subsequent headache outcomes following physiotherapy remains uncertain.
This retrospective cohort study will examine whether baseline cervical JPE is associated with headache intensity at the observed treatment-completion assessment among adults clinically classified with CGH who received routine clinician-directed physiotherapy. The study will use routinely collected clinical records from the outpatient physiotherapy department of Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India. Clinical records from January 2023 through December 2025 will be reviewed.
The study population consists of adults clinically classified with CGH according to a retrospective operational classification rule derived from the Cervicogenic Headache International Study Group criteria. The retrospective classification required documentation of at least three of five clinical features: unilateral headache without sideshift, headache provoked by neck movement or sustained cervical postures, restricted cervical range of motion, ipsilateral neck/shoulder/arm pain, and evidence of cervical musculoskeletal dysfunction on clinical examination.
The primary exposure is baseline mean cervical JPE. JPE was assessed before physiotherapy using a CROM device. Patients were seated with the back supported and feet flat on the floor, with the eyes closed. A head-mounted laser pointer attached to the CROM device projected onto a wall-mounted target. After memorizing the starting position, the patient actively moved the cervical spine into right rotation, left rotation, flexion, and extension and then attempted to return to the starting position. Angular displacement from the starting position was recorded in degrees. Three trials were performed for each direction, and the mean absolute repositioning error across the four directions was used as the primary JPE measure.
The primary outcome is headache intensity recorded at the observed treatment-completion assessment using the 11-point Numeric Pain Rating Scale (NPRS). The treatment-completion assessment was recorded at the final treatment session or within one week of treatment completion. Because treatment duration was not standardized, the observed treatment-completion assessment represents the outcome at the time the patient's routine physiotherapy episode was completed rather than a standardized follow-up time point.
The primary analysis will evaluate the adjusted association between baseline cervical JPE and treatment-completion NPRS using multivariable linear regression within an ANCOVA framework. Baseline NPRS, age, sex, and baseline Neck Disability Index will be included as prespecified covariates based on clinical relevance and the conceptual framework for the study. The analysis will estimate the difference in treatment-completion headache intensity associated with each one-degree increase in baseline mean cervical JPE while holding the prespecified covariates constant.
The study distinguishes a prognostic factor from a treatment-effect modifier. A prognostic factor is a baseline characteristic associated with an outcome among patients receiving treatment, whereas a treatment-effect modifier would require evidence that the baseline characteristic changes the relative benefit of one treatment compared with another treatment or control condition. Because this study is retrospective and does not randomly assign or compare treatment interventions, it is designed to evaluate prognostic association and cannot establish whether baseline JPE modifies the effect of physiotherapy.
Secondary and exploratory analyses will examine whether baseline JPE is associated with achievement of a prespecified reduction of at least 2 points in NPRS during the observed treatment period. Additional exploratory analyses include receiver operating characteristic analysis, assessment of discriminatory ability, bootstrap internal validation, and direction-specific analyses of JPE. These analyses are considered exploratory because of the structural dependence of the responder definition on baseline and treatment-completion NPRS and because the study does not include an independently defined prospective prediction endpoint.
The study will also describe changes in headache intensity and, where available, cervical JPE between baseline and treatment completion. These analyses are descriptive and will not be interpreted as evidence that physiotherapy caused the observed changes because the study has no untreated comparison group and treatment was not standardized or assigned by the investigators.
Patients in the retrospective cohort received routine clinician-directed multimodal physiotherapy according to clinical practice. Documented treatment approaches included combined manual therapy and exercise, exercise alone, and manual therapy alone. Interventions commonly included cervical joint mobilization, deep cervical flexor training, cervical stabilization exercises, scapular strengthening, postural correction, cervical proprioceptive retraining, and prescribed home exercises. Treatment exposure was not determined by the study investigators.
The study uses routinely collected clinical information and does not alter patient treatment. Individual informed consent was waived because of the retrospective design and use of de-identified clinical data. The study was approved by the Institutional Review Board of Saveetha Institute of Medical and Technical Sciences (IHEC/SDC/PHYSIO/2025-0142) and was conducted in accordance with the Declaration of Helsinki. Reporting follows the STROBE guidance for observational cohort studies.
The principal analytical objective is to determine whether baseline cervical JPE provides information about subsequent headache intensity beyond baseline headache severity, disability, age, and sex. The study does not seek to establish a causal effect of JPE on headache outcomes, determine the effectiveness of a specific physiotherapy intervention, or recommend treatment selection based on JPE.
The retrospective nature of the study introduces potential limitations, including residual confounding, selection related to treatment engagement, non-standardized treatment duration, variation in treatment exposure, and non-standardized timing of treatment-completion assessment. The study therefore provides preliminary evidence regarding group-level prognostic association. Prospective studies with standardized diagnostic criteria, protocolized treatment, blinded JPE assessment, fixed follow-up time points, and external validation would be required to determine the clinical utility of JPE as a prognostic factor.
- Conditions
- Cervicogenic Headache, Cervicogenic Headaches
- Being tested
- Routine clinician-directed physiotherapy
- Keywords
- cervicogenic headache, joint position error, cervical proprioception, physiotherapy, prognosis, prognostic factor
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine clinician-directed physiotherapyOther
Participants received routine clinician-directed multimodal physiotherapy as part of usual outpatient clinical care. Treatment was not assigned or standardized by the investigators. Documented physiotherapy approaches primarily included cervical joint mobilization, deep cervical flexor training, cervical stabilization exercises, scapular strengthening, postural correction, cervical proprioceptive retraining, and a prescribed home exercise programme. Three treatment approaches were documented: combined manual therapy and exercise, exercise only, and manual therapy only. Treatment duration and number of sessions varied according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Adults Clinically Classified With Cervicogenic Headache | Adults aged 18-65 years clinically classified with cervicogenic headache based on an operationalized retrospective classification rule derived from Cervicogenic Headache International Study Group criteria. Participants had baseline cervical joint position error (JPE) measured before physiotherapy and received routine clinician-directed physiotherapy in outpatient practice. Treatment was not assigned or standardized by the investigators. Documented physiotherapy approaches included combined manual therapy and exercise, exercise only, and manual therapy only. The final analytical cohort comprised 126 patients who completed at least four physiotherapy sessions and had a treatment-completion outcome assessment. Receives: Other: Routine clinician-directed physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache intensity at treatment completion (NPRS)
Headache intensity measured using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain), recorded at the final treatment session or within one week of treatment completion. The primary outcome was the treatment-completion NPRS score.
Measured: At the final treatment session or within one week of treatment completion (observed treatment period: 4-18 weeks).
Secondary outcomes (3)
Change in Neck Disability Index (NDI)
Change in Neck Disability Index (NDI) score from baseline to treatment completion. The NDI is a 0-50 scale assessing neck-related disability.
Measured: From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in headache frequency
Change in headache frequency from baseline to treatment completion, measured as the number of headache days per month.
Measured: From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in mean cervical joint position error (JPE)
Change in mean cervical joint position error from baseline to post-treatment assessment, measured in degrees using a standardized cervical head-repositioning protocol. This outcome was assessed in the subset of participants with available post-treatment JPE data (n = 88).
Measured: From baseline assessment to post-treatment assessment; post-treatment JPE was assessed at treatment completion in participants with available follow-up JPE data (n=88), with treatment duration ranging from 4-18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2025
- Primary completion27 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Raquib, Saveetha University
- Investigators
- Manisha Jayakumar, Principal investigator, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS), Chennai, Tamil Nadu, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796711
- Sponsor's protocol ID
- 109/12/2025/ISRB/UGSR/SCPT
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall T, Chan HT, Christensen L, Odenthal B, Wells C, Robinson K. Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. J Orthop Sports Phys Ther. 2007 Mar;37(3):100-7. doi: 10.2519/jospt.2007.2379.
PubMed 17416124Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
PubMed 12221344Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
PubMed 19747657Nilsson N. The prevalence of cervicogenic headache in a random population sample of 20-59 year olds. Spine (Phila Pa 1976). 1995 Sep 1;20(17):1884-8. doi: 10.1097/00007632-199509000-00008.
PubMed 8560336Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Sjaastad O, Fredriksen TA, Pfaffenrath V. Cervicogenic headache: diagnostic criteria. The Cervicogenic Headache International Study Group. Headache. 1998 Jun;38(6):442-5. doi: 10.1046/j.1526-4610.1998.3806442.x. No abstract available.
PubMed 9664748
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Cervical Joint Position Error and Headache Intensity at Treatment Completion in Adults Clinically Classified With Cervicogenic Headache: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07796711
- Acronym / sponsor ID
- 109/12/2025/ISRB/UGSR/SCPT
- Conditions
- Cervicogenic Headache, Cervicogenic Headaches
- Keywords
- cervicogenic headache, joint position error, cervical proprioception, physiotherapy, prognosis, prognostic factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 1 Sep 2026 (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.
Cervicogenic headache is a type of headache associated with problems or dysfunction in the neck. People with cervicogenic headache may experience headache pain along with neck pain, reduced neck movement, and difficulties with normal neck function. Cervical joint position error (JPE) is a measure of how accurately a person can return their head to its starting position after moving the neck. A greater JPE may indicate reduced accuracy of neck position sense.
The purpose of this retrospective study is to determine whether the amount of cervical JPE measured before physiotherapy is associated with headache intensity at the completion of physiotherapy in adults clinically classified with cervicogenic headache. The study will also examine whether baseline cervical JPE is associated with achieving a meaningful reduction in headache intensity.
The study will use existing clinical records of adults aged 18 to 65 years who were clinically classified with cervicogenic headache and received routine physiotherapy at a university teaching hospital. Records from January 2023 to December 2025 will be reviewed. Participants must have had cervical JPE and headache intensity recorded before physiotherapy and must have completed at least four physiotherapy sessions with a treatment-completion assessment.
Cervical JPE will be assessed from the recorded baseline measurements obtained using a CROM (Cervical Range of Motion) device. Headache intensity will be assessed using the Numeric Pain Rating Scale (NPRS), where 0 represents no pain and 10 represents the worst imaginable pain. The primary outcome will be headache intensity recorded at the treatment-completion assessment.
The study will compare baseline cervical JPE with treatment-completion headache intensity while taking into account other relevant factors, including baseline headache intensity, neck disability, age, and sex. The study will also examine whether participants achieved a reduction of at least 2 points on the NPRS during the observed treatment period.
As this is a retrospective observational study, the researchers will not assign or change participants' treatment. The study will use information already available in clinical records and will not require participants to receive additional treatment or undergo additional assessments. The study is intended to determine whether baseline cervical JPE may be associated with subsequent headache outcomes and whether it may be useful as a potential prognostic factor. It will not determine whether cervical JPE causes headache or whether JPE should be used to select a particular physiotherapy treatment.
The findings may help guide future research on factors that are associated with treatment outcomes in people with cervicogenic headache. Further prospective studies may be needed to determine whether cervical JPE has useful prognostic value at the individual patient level.
Detailed description
Cervicogenic headache (CGH) is a secondary headache disorder associated with cervical musculoskeletal dysfunction. Clinical features may include unilateral headache, headache provoked by neck movement or sustained cervical postures, restricted cervical range of motion, neck or shoulder pain, and evidence of cervical musculoskeletal dysfunction. Physiotherapy is commonly used in the management of CGH; however, outcomes following physiotherapy may vary between individuals.
Cervical joint position error (JPE) is a measure of cervical sensorimotor accuracy. It assesses the ability of an individual to accurately return the head to a previously established starting position following active cervical movement. Increased JPE may reflect impaired cervical proprioception or sensorimotor control. Although elevated cervical JPE has been reported in individuals with neck pain and CGH, its potential prognostic relevance for subsequent headache outcomes following physiotherapy remains uncertain.
This retrospective cohort study will examine whether baseline cervical JPE is associated with headache intensity at the observed treatment-completion assessment among adults clinically classified with CGH who received routine clinician-directed physiotherapy. The study will use routinely collected clinical records from the outpatient physiotherapy department of Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India. Clinical records from January 2023 through December 2025 will be reviewed.
The study population consists of adults clinically classified with CGH according to a retrospective operational classification rule derived from the Cervicogenic Headache International Study Group criteria. The retrospective classification required documentation of at least three of five clinical features: unilateral headache without sideshift, headache provoked by neck movement or sustained cervical postures, restricted cervical range of motion, ipsilateral neck/shoulder/arm pain, and evidence of cervical musculoskeletal dysfunction on clinical examination.
The primary exposure is baseline mean cervical JPE. JPE was assessed before physiotherapy using a CROM device. Patients were seated with the back supported and feet flat on the floor, with the eyes closed. A head-mounted laser pointer attached to the CROM device projected onto a wall-mounted target. After memorizing the starting position, the patient actively moved the cervical spine into right rotation, left rotation, flexion, and extension and then attempted to return to the starting position. Angular displacement from the starting position was recorded in degrees. Three trials were performed for each direction, and the mean absolute repositioning error across the four directions was used as the primary JPE measure.
The primary outcome is headache intensity recorded at the observed treatment-completion assessment using the 11-point Numeric Pain Rating Scale (NPRS). The treatment-completion assessment was recorded at the final treatment session or within one week of treatment completion. Because treatment duration was not standardized, the observed treatment-completion assessment represents the outcome at the time the patient's routine physiotherapy episode was completed rather than a standardized follow-up time point.
The primary analysis will evaluate the adjusted association between baseline cervical JPE and treatment-completion NPRS using multivariable linear regression within an ANCOVA framework. Baseline NPRS, age, sex, and baseline Neck Disability Index will be included as prespecified covariates based on clinical relevance and the conceptual framework for the study. The analysis will estimate the difference in treatment-completion headache intensity associated with each one-degree increase in baseline mean cervical JPE while holding the prespecified covariates constant.
The study distinguishes a prognostic factor from a treatment-effect modifier. A prognostic factor is a baseline characteristic associated with an outcome among patients receiving treatment, whereas a treatment-effect modifier would require evidence that the baseline characteristic changes the relative benefit of one treatment compared with another treatment or control condition. Because this study is retrospective and does not randomly assign or compare treatment interventions, it is designed to evaluate prognostic association and cannot establish whether baseline JPE modifies the effect of physiotherapy.
Secondary and exploratory analyses will examine whether baseline JPE is associated with achievement of a prespecified reduction of at least 2 points in NPRS during the observed treatment period. Additional exploratory analyses include receiver operating characteristic analysis, assessment of discriminatory ability, bootstrap internal validation, and direction-specific analyses of JPE. These analyses are considered exploratory because of the structural dependence of the responder definition on baseline and treatment-completion NPRS and because the study does not include an independently defined prospective prediction endpoint.
The study will also describe changes in headache intensity and, where available, cervical JPE between baseline and treatment completion. These analyses are descriptive and will not be interpreted as evidence that physiotherapy caused the observed changes because the study has no untreated comparison group and treatment was not standardized or assigned by the investigators.
Patients in the retrospective cohort received routine clinician-directed multimodal physiotherapy according to clinical practice. Documented treatment approaches included combined manual therapy and exercise, exercise alone, and manual therapy alone. Interventions commonly included cervical joint mobilization, deep cervical flexor training, cervical stabilization exercises, scapular strengthening, postural correction, cervical proprioceptive retraining, and prescribed home exercises. Treatment exposure was not determined by the study investigators.
The study uses routinely collected clinical information and does not alter patient treatment. Individual informed consent was waived because of the retrospective design and use of de-identified clinical data. The study was approved by the Institutional Review Board of Saveetha Institute of Medical and Technical Sciences (IHEC/SDC/PHYSIO/2025-0142) and was conducted in accordance with the Declaration of Helsinki. Reporting follows the STROBE guidance for observational cohort studies.
The principal analytical objective is to determine whether baseline cervical JPE provides information about subsequent headache intensity beyond baseline headache severity, disability, age, and sex. The study does not seek to establish a causal effect of JPE on headache outcomes, determine the effectiveness of a specific physiotherapy intervention, or recommend treatment selection based on JPE.
The retrospective nature of the study introduces potential limitations, including residual confounding, selection related to treatment engagement, non-standardized treatment duration, variation in treatment exposure, and non-standardized timing of treatment-completion assessment. The study therefore provides preliminary evidence regarding group-level prognostic association. Prospective studies with standardized diagnostic criteria, protocolized treatment, blinded JPE assessment, fixed follow-up time points, and external validation would be required to determine the clinical utility of JPE as a prognostic factor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Clinically Classified With Cervicogenic Headache | – | Other: Routine clinician-directed physiotherapyAdults aged 18-65 years clinically classified with cervicogenic headache based on an operationalized retrospective classification rule derived from Cervicogenic Headache International Study Group criteria. Participants had baseline cervical joint position error (JPE) measured before physiotherapy and received routine clinician-directed physiotherapy in outpatient practice. Treatment was not assigned or standardized by the investigators. Documented physiotherapy approaches included combined manual therapy and exercise, exercise only, and manual therapy only. The final analytical cohort comprised 126 patients who completed at least four physiotherapy sessions and had a treatment-completion outcome assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective observational cohort comprised adults aged 18-65 years who were clinically classified with cervicogenic headache and received routine clinician-directed physiotherapy at the outpatient physiotherapy department of Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS), Chennai, Tamil Nadu, India. Clinical records from January 2023 to December 2025 were reviewed. Participants had baseline cervical joint position error and headache intensity documented before physiotherapy and completed at least four physiotherapy sessions with a treatment-completion outcome assessment. Of 172 records identified, 46 were excluded after applying eligibility criteria, resulting in a final analytical cohort of 126 patients.
Key inclusion criteria (9 listed)
- Adults aged 18-65 years.
- Clinically classified with cervicogenic headache (CGH) based on the retrospective classification rule derived from the Cervicogenic Headache
- International Study Group criteria.
- At least 3 of the 5 documented CGH features were present.
- Baseline cervical joint position error (JPE) was measured before physiotherapy.
Key exclusion criteria (9 listed)
- History of cervical spine surgery.
- Cervical trauma or whiplash within the previous 6 months.
- Cervical fracture, instability, or severe structural pathology.
- Rheumatoid or other inflammatory cervical disease.
- Neurological disorders affecting cervical sensorimotor function.
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 |
|---|---|---|
| Routine clinician-directed physiotherapyParticipants received routine clinician-directed multimodal physiotherapy as part of usual outpatient clinical care. Treatment was not assigned or standardized by the investigators. Documented physiotherapy approaches primarily included cervical joint mobilization, deep cervical flexor training, cervical stabilization exercises, scapular strengthening, postural correction, cervical proprioceptive retraining, and a prescribed home exercise programme. Three treatment approaches were documented: combined manual therapy and exercise, exercise only, and manual therapy only. Treatment duration and number of sessions varied according to routine clinical practice. | Other | Adults Clinically Classified With Cervicogenic Headache |
Primary outcome
Headache intensity at treatment completion (NPRS)
Time frame: At the final treatment session or within one week of treatment completion (observed treatment period: 4-18 weeks).
Headache intensity measured using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain), recorded at the final treatment session or within one week of treatment completion. The primary outcome was the treatment-completion NPRS score.
3 secondary outcomes
Change in Neck Disability Index (NDI)
Time frame: From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in headache frequency
Time frame: From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in mean cervical joint position error (JPE)
Time frame: From baseline assessment to post-treatment assessment; post-treatment JPE was assessed at treatment completion in participants with available follow-up JPE data (n=88), with treatment duration ranging from 4-18 weeks.
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 1 Sep 2026.
- Background: PubMed 17416124Hall T, Chan HT, Christensen L, Odenthal B, Wells C, Robinson K. Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. J Orthop Sports Phys Ther. 2007 Mar;37(3):100-7. doi: 10.2519/jospt.2007.2379.
- Background: PubMed 12221344Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
- Background: PubMed 19747657Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
- Background: PubMed 8560336Nilsson N. The prevalence of cervicogenic headache in a random population sample of 20-59 year olds. Spine (Phila Pa 1976). 1995 Sep 1;20(17):1884-8. doi: 10.1097/00007632-199509000-00008.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 9664748Sjaastad O, Fredriksen TA, Pfaffenrath V. Cervicogenic headache: diagnostic criteria. The Cervicogenic Headache International Study Group. Headache. 1998 Jun;38(6):442-5. doi: 10.1046/j.1526-4610.1998.3806442.x. No abstract available.
- Individual participant dataSharing planned: No
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Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.
Post Traumatic Headache, Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Mulligan Technique Versus Proprioceptive Training in Cervicogenic Headache
Cervicogenic Headache
Recruiting
"Effectiveness of Kaltenborn Mobilization Techniques Versus Maitland Mobilization on Management of Cervicogenic Headache
Cervicogenic Headache
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.
Manisha Jayakumar principal investigator
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS), Chennai, Tamil Nadu, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervicogenic Headache and Cervicogenic Headaches, run by Saveetha University at 1 site in India.
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 9 inclusion and 9 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 1 Sep 2026. 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 India. 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?
Headache intensity at treatment completion (NPRS) (time frame: At the final treatment session or within one week of treatment completion (observed treatment period: 4-18 weeks).). 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 NCT07796711, which also lists 6 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 1 Sep 2026.