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Baseline Cervical Joint Position Error and Headache Intensity

27. srpna 2026 aktualizováno: Farhan Raquib, Saveetha University

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.

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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

126

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Tamil Nadu
      • Chennai, Tamil Nadu, Indie, 602105
        • Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS)

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

Inclusion Criteria:

  • 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.
  • Completed at least 4 physiotherapy sessions.
  • Had at least one treatment-completion outcome assessment.
  • Clinical records contained sufficiently complete baseline and outcome information.

Exclusion Criteria:

  • 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.
  • Migraine or another primary headache disorder as the predominant diagnosis.
  • Systemic malignancy affecting the cervical region.
  • Incomplete baseline JPE or treatment-completion outcome data.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Headache intensity at treatment completion (NPRS)
Časové okno: 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.
At the final treatment session or within one week of treatment completion (observed treatment period: 4-18 weeks).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Neck Disability Index (NDI)
Časové okno: From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in Neck Disability Index (NDI) score from baseline to treatment completion. The NDI is a 0-50 scale assessing neck-related disability.
From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in headache frequency
Časové okno: From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in headache frequency from baseline to treatment completion, measured as the number of headache days per month.
From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.
Change in mean cervical joint position error (JPE)
Časové okno: 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.
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).
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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
NPRS responder status (≥2-point reduction)
Časové okno: From baseline NPRS assessment to the treatment-completion assessment; responder status was determined during the observed treatment period of 4-18 weeks.
Proportion of participants achieving a reduction of at least 2 points in NPRS from baseline to the treatment-completion assessment. This responder analysis was prespecified but was classified as secondary exploratory analysis because responder status is derived from baseline and treatment-completion NPRS.
From baseline NPRS assessment to the treatment-completion assessment; responder status was determined during the observed treatment period of 4-18 weeks.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Manisha Jayakumar, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS), Chennai, Tamil Nadu, India

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. září 2025

Primární dokončení (Aktuální)

27. září 2025

Dokončení studie (Aktuální)

20. října 2025

Termíny zápisu do studia

První předloženo

27. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

27. srpna 2026

První zveřejněno (Aktuální)

1. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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