Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches

NCT03142945 | Completed

• 1 other identifier: GrandVSU
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

In addition to manual therapy, mobilizations, manipulations, and exercise, the McKenzie method of Mechanical Diagnosis and Therapy (MDT) is currently being used to treat headaches. However, there is little supportive evidence about the efficacy of this type of treatment. The MDT method focuses on actively involving the patient in education and self-management of pain. The focus is to have the patient learn about his/her condition and how to manage the symptoms independently when possible. With regards to research that has been conducted on the use of MDT with headaches, one study compared mechanical traction, rhythmic impulse, and MDT exercises in relieving tension-type headaches (TTH). Mechanical cervical traction was found to be more effective at reducing headaches in both infrequent episodic and frequent episodic TTH. While MDT was used in this study, a general treatment was prescribed to each patient in that group without consideration to directional preference. This treatment had the patients perform the same exercises in the same progression, including four extension exercises, one flexion exercise, two lateral flexion exercise, and one rotation exercise. In addition, they performed the exercises for the same length of time for the same number of repetitions. The study was unclear about whether the exercises were administered by physical therapists or whether the practitioners were MDT credentialed. One case study described the treatment of a cervicogenic headache using the MDT retraction progression along with therapeutic exercises that included deep neck flexor and extensor strengthening and stretching of neck musculature as indicated . The patient reported that performing retractions at home provided him relief from his headaches for progressively longer periods of time as his treatment progressed. By the end of the treatment, the patient no longer experienced headaches. The results from this article support the proposition that headaches which present with mechanical origins can be successfully treated with the MDT approach.

Conditions

Headaches, Tension

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  functional questionnaire

  3 weeks

Secondary Outcomes (2)

• Numeric Pain Rating Scale

  3 weeks

• Cervical Spine Range of Motion

  3 weeks

Study Arms (2)

Traditional Physical Therapy Group

ACTIVE COMPARATOR

Traditional Physical Therapy Group Physical therapy-based interventions: home exercises (not repeated motions), stretching, modalities, and posture instruction.

Other: Traditional Physical Therapy

MDT based physical therapy

EXPERIMENTAL

MDT based physical therapy Physical therapy-based interventions: home exercises (including repeated motions), stretching, modalities, and posture instruction.

Other: MDT based physical therapy

Interventions

Traditional Physical Therapy OTHER

Physical therapy-based interventions

Traditional Physical Therapy Group

MDT based physical therapy OTHER

MDT based physical therapy

MDT based physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old: documentation ie: driver's license
• Decrease in active cervical range of motion, compared to normal values established by Magee \[8\]: Measured by Mary Free Bed physical therapists using the Cervical Range of Motion inclinometer (i.e., the CROM).
• Headache symptoms change based on manual pressure to cervical spine, posture, or neck movement: Tested by Mary Free Bed physical therapist during evaluation
• Cognition adequate for understanding (alert and oriented x3): Tested by Mary Free Bed physical therapists
• English-speaking, or able to understand English well enough to follow directions: Determined at initial evaluation. Translators will not be available during the study due to lack of funding and availability.

You may not qualify if:

• Cervical spine fusion less than 6 months: Medical documentation and history portion of initial evaluation. Medical documentation to be reviewed will only be viewed by the physical therapist and will only include information that is typically available to physical therapists in standard practice.
• Trauma to neck or head within the past 3 months: Medical documentation and history portion of initial evaluation
• Concussion currently undergoing treatment: Medical documentation and history portion of initial evaluation
• Signs and symptoms of vertebral artery insufficiency: history portion of initial evaluation and potentially the vertebral artery test performed by the Mary Free Bed physical therapists
• Diagnosis of Rheumatoid Arthritis or Down Syndrome: Medical documentation and history portion of initial evaluation
• Constitutional signs or symptoms: nausea, vomiting, profuse sweating, dizziness, etc related to systemic illness: history portion of initial evaluation
• Signs and symptoms of poor upper cervical spine ligament integrity: Identified through specific manual upper cervical ligament tests performed by the Mary Free Bed physical therapists
• Connective tissue disorders: Ehlers-Danlos: Medical documentation and history portion of initial evaluation
• Chiari malformation: Medical documentation and history portion of initial evaluation
• Signs and symptoms or evidence of myelopathy: Medical documentation and history portion of initial evaluation
• Diagnosis of dissociative personality disorder: Medical documentation and history portion of initial evaluation
• Pregnant: Medical documentation and history portion of initial evaluation
• Neuropsychology issues such as inability to follow multistep directions and short term memory loss: Medical documentation and history portion of initial evaluation

Sponsors & Collaborators

• Grand Valley State University: lead
• Mary Free Bed Rehabilitation Hospital: collaborator

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Theresa Bacon-Baguley, PhD

  Grand Valley State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be advised of their group until they exit the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Therapy

Model Details: Two randomized groups. One receiving traditional physical therapy treatments for patients with mechanical headaches. The other will receive an MDT- based approach.

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 8, 2017
• Study Start: May 15, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)