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

This study is currently recruiting participants.
Verified July 2017 by Daniel Vaughn, Grand Valley State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03142945
First Posted: May 8, 2017
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Mary Free Bed Rehabilitation Hospital
Information provided by (Responsible Party):
Daniel Vaughn, Grand Valley State University
  Purpose

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.


Condition Intervention
Headaches, Tension Other: Traditional Physical Therapy Other: MDT based physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two randomized groups. One receiving traditional physical therapy treatments for patients with mechanical headaches. The other will receive an MDT- based approach.
Masking: Single (Participant)
Masking Description:
Patients will not be advised of their group until they exit the study
Primary Purpose: Treatment
Official Title: Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches

Resource links provided by NLM:


Further study details as provided by Daniel Vaughn, Grand Valley State University:

Primary Outcome Measures:
  • Neck Disability Index [ Time Frame: 3 weeks ]
    functional questionnaire


Secondary Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: 3 weeks ]
    Pain scale

  • Cervical Spine Range of Motion [ Time Frame: 3 weeks ]
    Active Range of Motion


Estimated Enrollment: 34
Actual Study Start Date: May 15, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Physical Therapy Group
Traditional Physical Therapy Group Physical therapy-based interventions: home exercises (not repeated motions), stretching, modalities, and posture instruction.
Other: Traditional Physical Therapy
Physical therapy-based interventions
Experimental: MDT based physical therapy
MDT based physical therapy Physical therapy-based interventions: home exercises (including repeated motions), stretching, modalities, and posture instruction.
Other: MDT based physical therapy
MDT based physical therapy

Detailed Description:

Headaches affect an estimated 46% of adults worldwide, and the pain can have a detrimental effect on an individual's livelihood. In a two-week time period, 12.7% of the US workforce was unable to productively work due to pain, with headache pain as the most common complaint. For those with headache pain, this resulted in 3.5 +/- 0.1 hours of productivity lost in a week. Quality of life, financial situation, employment, and social involvement are negatively impacted by headache pain. Coworkers and family may have to handle work or personal responsibilities that those with headaches are unable to fulfill.

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.

A study in Poland compared MDT interventions to a control group that received therapeutic exercise, massage, and ultra-red radiation for patients with cervical derangement. Although not targeted at patients with a primary complaint of headache, the percentage of patients in the MDT group experiencing headache decreased from 80% to 3.33% whereas the percentage of patients in the control group experiencing headaches decreased from 83.87% to 51.61%. This indicates that MDT may be an effective treatment for headaches with a mechanical component.

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-65 years old: documentation ie: driver's license
  2. 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).
  3. Headache symptoms change based on manual pressure to cervical spine, posture, or neck movement: Tested by Mary Free Bed physical therapist during evaluation
  4. Cognition adequate for understanding (alert and oriented x3): Tested by Mary Free Bed physical therapists
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Trauma to neck or head within the past 3 months: Medical documentation and history portion of initial evaluation
  3. Concussion currently undergoing treatment: Medical documentation and history portion of initial evaluation
  4. 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
  5. Diagnosis of Rheumatoid Arthritis or Down Syndrome: Medical documentation and history portion of initial evaluation
  6. Constitutional signs or symptoms: nausea, vomiting, profuse sweating, dizziness, etc related to systemic illness: history portion of initial evaluation
  7. 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
  8. Connective tissue disorders: Ehlers-Danlos: Medical documentation and history portion of initial evaluation
  9. Chiari malformation: Medical documentation and history portion of initial evaluation
  10. Signs and symptoms or evidence of myelopathy: Medical documentation and history portion of initial evaluation
  11. Diagnosis of dissociative personality disorder: Medical documentation and history portion of initial evaluation
  12. Pregnant: Medical documentation and history portion of initial evaluation
  13. Neuropsychology issues such as inability to follow multistep directions and short term memory loss: Medical documentation and history portion of initial evaluation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142945


Contacts
Contact: Dan W Vaughn, PT, PhD 616-331-2678 vaughnd@gvsu.edu

Locations
United States, Michigan
Grand Valley State University Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Dan Vaughn, PT, PhD    616-331-2678    vaughnd@gvsu.edu   
Contact: Theresa Bacon-Baguley, PhD    616-331-5986    bacon-bt@gvsu.edu   
Sponsors and Collaborators
Grand Valley State University
Mary Free Bed Rehabilitation Hospital
Investigators
Study Chair: Theresa Bacon-Baguley, PhD Grand Valley State University
  More Information

Responsible Party: Daniel Vaughn, Professor, Department of Physical Therapy, Grand Valley State University
ClinicalTrials.gov Identifier: NCT03142945     History of Changes
Other Study ID Numbers: GrandVSU
First Submitted: April 25, 2017
First Posted: May 8, 2017
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases