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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Procedure: Musculoskeletal Physical Therapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ronald Schenk, PhD; Phone Number: 716-566-8756; Email: ronald.schenk@tufts.edu
• Study Contact Backup: Name: Eric Miller, DSc; Phone Number: 716-912-9046; Email: millere@dyc.edu

Study Locations

• United States
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Recruiting
      • Faith Regional Rehabilitation Therapies
      • Contact: Lin Pu, PT; Phone Number: 402-644-7396; Email: ptlin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 weeks
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".	Baseline and 6 weeks
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.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Faith Regional Health Services
• Collaborators: Tufts University; D'Youville College
• Investigators: Study Director: Ronal Schenk, PhD, Tufts University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Neck Pain; Cervicogenic Headache; McKenzie
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: 081468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If data is shared it would be deidentified data reported in aggregate format only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No