NCT07796711

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

26 days

First QC Date

August 27, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

cervicogenic headachejoint position errorcervical proprioceptionphysiotherapyprognosisprognostic factor

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.

  • Change in headache frequency

    From baseline assessment to the treatment-completion assessment; treatment duration ranged from 4-18 weeks.

  • Change in mean cervical joint position error (JPE)

    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.

Other Outcomes (1)

  • NPRS responder status (≥2-point reduction)

    From baseline NPRS assessment to the treatment-completion assessment; responder status was determined during the observed treatment period of 4-18 weeks.

Study Arms (1)

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.

Other: Routine clinician-directed physiotherapy

Interventions

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.

Adults Clinically Classified With Cervicogenic Headache

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences (SIMATS)

Chennai, Tamil Nadu, 602105, India

Location

Related Publications (6)

  • 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.

    PMID: 17416124BACKGROUND
  • Jull 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.

    PMID: 12221344BACKGROUND
  • Bogduk 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.

    PMID: 19747657BACKGROUND
  • Nilsson 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.

    PMID: 8560336BACKGROUND
  • Headache 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.

    PMID: 29368949BACKGROUND
  • Sjaastad 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.

    PMID: 9664748BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Manisha Jayakumar

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

September 1, 2025

Primary Completion

September 27, 2025

Study Completion

October 20, 2025

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations