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Status unknownNCT05212844Updated Jan 28, 2022

McKenzie Method of Mechanical Diagnosis and Therapy for Management of Cervicogenic Headache: A Prospective Case Series

An observational study in Cervicogenic Headache, sponsored by Faith Regional Health Services. Status unknown at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Faith Regional Health Services · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
19 Years to 70 Years
Sex
All
01

Study summary

The goal of this study is to examine the effectiveness the Mechanical Diagnosis and Therapy (MDT) approach for the management patients with neck related headache that are referred to a hospital based out-patient physical therapy clinic.

Background: Headache conditions are among the most common complaints causing people to seek medical care. An estimated 14 billion dollars are spent annually on treating headaches. Neck related headache is characterized by pain which comes from the cervical spine (neck) and could be referred to the head and/or face. CGH is frequently managed clinically utilizing an MDT approach however to date there is limited research available examining the effectiveness of this intervention type in a population with CGH.

Read the detailed description

Objective: The goal of this case-series is to examine the effectiveness the Mechanical Diagnosis and Therapy (MDT) approach for the management patients with cervicogenic headache referred to a hospital based out-patient physical therapy clinic.

Design: Prospective consecutive case series.

Background: Headache conditions are among the most common complaints causing people to seek medical care. An estimated 14 billion dollars are spent annually on treating headaches. Cervicogenic headache (CGH) is described as a secondary type of headache characterized by pain which emanates from the cervical spine and is potentially referred to one or more regions of the head and/or face. CGH is frequently managed clinically utilizing an MDT approach however to date there is limited research available examining the effectiveness of this intervention type in a population with CGH.

Study Selection Criteria: Convenience sampling will be utilized. Subjects diagnosed with CGH and meeting inclusion criteria will be recruited from a population of patients referred by their physician to a hospital based out-patient physical therapy clinic for treatment.

Procedures: Subjects meeting inclusion criteria will be evaluated, classified, and receive interventions based on the MDT approach. Outcome measures utilized will include the Neck Disability Index (NDI), Numeric Pain Rating Scale (NRS), and Headache Disability Index (HDI) will be completed at baseline, visit 5, and visit 10 or discharge, whichever comes first.

Data Management: Descriptive statistics will be used to describe sample characteristics. A repeated measures ANOVA will be utilized to identify changes in group means.

Key Words: Cervicogenic Headache, Mechanical Diagnosis and Treatment.

02

Conditions studied

  • Cervicogenic Headache

Keywords

  • Cervicogenic Headache
  • McKenzie
  • Neck Pain
03

In context

Post-Traumatic Headache

188 studies on the registry are indexed under Post-Traumatic Headache; 51 are open to participants now.

This study's planned enrollment of 20 is below the median of 90 across 19 observational studies indexed under Post-Traumatic Headache.

Browse Post-Traumatic Headache studies →

Lead sponsor

This is the only study on the registry with Faith Regional Health Services as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A sample of 15-20 subjects is expected. Subjects referred to physical therapy by their physician and meeting the inclusion criteria will be recruited for participation.

Inclusion criteria

  • Age 19-70
  • During the physical therapy examination, it is found that movements, static positions, or postures affect the patient headache symptoms.
  • Pain presents as unilateral or bilateral head/neck pain and/or stiffness
  • Headache frequency at least 1x/week
  • Headache symptoms are present for at least 3 months
  • Dizziness and/or tinnitus affected by neck movements or positions
  • Patient has been previously screened for their headache symptoms by their MD

Exclusion criteria

Exclusion Criteria:

  • Headache is determined to be of non-cervical origin including migraine, cluster headache, tension-type headache
  • Malignancy/infection
  • Cranial or cervical vascular disorder
  • Substance use or withdrawal
  • Acute Post cervical surgery
  • Psychosis/psychiatric disorder/post-traumatic stress disorder
  • Received nerve block or Botox injections during therapy
  • Vertigo with nystagmus is present
  • Involved in litigation related to headache complaints
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • ProcedureMusculoskeletal Physical Therapy

    Therapeutic exercise and manual physical therapy based on the individual response to end range repeated movements.

    Also known as: Mechanical Diagnosis and Treatment

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Neck Disability Index (NDI) Scores to Discharge

    The NDI measures the patient perceived level of function related to neck pain. The NDI is a 10 item questionnaire scored from 0-50 with higher scores indicating greater levels of disability.

    Time frame: Baseline and 6 weeks

  2. Change from Baseline in Numeric Pain Rating Scale (NPRS) Scores to discharge

    The NPRS is an 11 item numeric scale that provides a patient rating of neck pain and headache symptoms. The scales corelates with a score of 0 indicating "no pain" and 10 indicating the "worst pain imaginable".

    Time frame: Baseline and 6 weeks

  3. Change from Baseline in Headache Disability Index (HDI) Scores to Discharge

    The HDI measures the patient perceived level of pain and disability related to headache symptoms. The HDI is a 25 item questionnaire scored from 0-100 with a higher score indicating a greater level of disability related to the patient headache symptoms.

    Time frame: Baseline and 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Faith Regional Rehabilitation Therapies
    Norfolk, Nebraska 68701, United States
    Recruiting
08

References and documents

Publications

  • Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med. 1999 Apr 26;159(8):813-8. doi: 10.1001/archinte.159.8.813. PubMed 10219926 ↗
  • Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available. PubMed 14979299 ↗
  • Jull G, Barrett C, Magee R, Ho P. Further clinical clarification of the muscle dysfunction in cervical headache. Cephalalgia. 1999 Apr;19(3):179-85. doi: 10.1046/j.1468-2982.1999.1903179.x. PubMed 10234466 ↗
  • Jull G, Kristjansson E, Dall'Alba P. Impairment in the cervical flexors: a comparison of whiplash and insidious onset neck pain patients. Man Ther. 2004 May;9(2):89-94. doi: 10.1016/S1356-689X(03)00086-9. PubMed 15040968 ↗
  • Nilsson N. A randomized controlled trial of the effect of spinal manipulation in the treatment of cervicogenic headache. J Manipulative Physiol Ther. 1995 Sep;18(7):435-40. PubMed 8568424 ↗
  • Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66. PubMed 22034615 ↗

Individual participant data

Plan to share: Undecided — If data is shared it would be deidentified data reported in aggregate format only.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05212844
Lead sponsor
Faith Regional Health Services
Collaborators
Tufts University, D'Youville College
Responsible party
Lan Lin Pu (Principal Investigator, Faith Regional Health Services) — Principal investigator
First posted
Jan 28, 2022
Start date
Dec 17, 2021
Primary completion
Jul 31, 2022 (estimated)
Completion
Jul 31, 2022 (estimated)
Last update
Jan 28, 2022

Study contacts

Ronald Schenk, PhD
Contact
ronald.schenk@tufts.edu
716-566-8756
Eric Miller, DSc
Contact
millere@dyc.edu
716-912-9046
Ronal Schenk, PhD
study director · Tufts University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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