Clinical trial NCT05212844: McKenzie Method of Mechanical Diagnosis and Therapy for Management of Cervicogenic Headache: A Prospective Case Series
Official title: Utilizing the McKenzie Method of Mechanical Diagnosis and Therapy for Management of Cervicogenic Headache: A Prospective Case Series
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervicogenic Headache
Keywords: Cervicogenic Headache
McKenzie
Neck Pain
Lead sponsor: Faith Regional Health Services
Sponsor class: OTHER
Collaborators: name: Tufts University
name: D'Youville College
First posted: 2022-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change from Baseline in Neck Disability Index (NDI) Scores to Discharge
timeFrame: Baseline and 6 weeks
measure: Change from Baseline in Numeric Pain Rating Scale (NPRS) Scores to discharge
timeFrame: Baseline and 6 weeks
measure: Change from Baseline in Headache Disability Index (HDI) Scores to Discharge
timeFrame: Baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Faith Regional Rehabilitation Therapies
state: Nebraska
Study officials:
affiliation: Tufts University
name: Ronal Schenk, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.