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

• Conditions: Cervicogenic Headache

• Registration Number: NCT05212844
• Lead Sponsor: Faith Regional Health Services

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.

Study Timeline

• Study Start: 2021-12-17
• Study First Submitted: 2021-12-17
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Neck Disability Index (NDI) Scores to Discharge	Baseline and 6 weeks	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.
Change from Baseline in Numeric Pain Rating Scale (NPRS) Scores to discharge	Baseline and 6 weeks	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".
Change from Baseline in Headache Disability Index (HDI) Scores to Discharge	Baseline and 6 weeks	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.

Trial Locations

Locations (1)

Faith Regional Rehabilitation Therapies; 🇺🇸 Norfolk, Nebraska, United States