Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
Primary Purpose
Headaches, Tension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Physical Therapy
MDT based physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Headaches, Tension
Eligibility Criteria
Inclusion Criteria:
- 18-65 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.
Exclusion Criteria:
- 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
Sites / Locations
- Grand Valley State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Physical Therapy Group
MDT based physical therapy
Arm Description
Traditional Physical Therapy Group Physical therapy-based interventions: home exercises (not repeated motions), stretching, modalities, and posture instruction.
MDT based physical therapy Physical therapy-based interventions: home exercises (including repeated motions), stretching, modalities, and posture instruction.
Outcomes
Primary Outcome Measures
Neck Disability Index
functional questionnaire
Secondary Outcome Measures
Numeric Pain Rating Scale
Pain scale
Cervical Spine Range of Motion
Active Range of Motion
Full Information
NCT ID
NCT03142945
First Posted
April 25, 2017
Last Updated
August 1, 2018
Sponsor
Grand Valley State University
Collaborators
Mary Free Bed Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03142945
Brief Title
Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
Official Title
Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grand Valley State University
Collaborators
Mary Free Bed Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headaches, Tension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Patients will not be advised of their group until they exit the study
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Physical Therapy Group
Arm Type
Active Comparator
Arm Description
Traditional Physical Therapy Group Physical therapy-based interventions: home exercises (not repeated motions), stretching, modalities, and posture instruction.
Arm Title
MDT based physical therapy
Arm Type
Experimental
Arm Description
MDT based physical therapy Physical therapy-based interventions: home exercises (including repeated motions), stretching, modalities, and posture instruction.
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy
Intervention Description
Physical therapy-based interventions
Intervention Type
Other
Intervention Name(s)
MDT based physical therapy
Intervention Description
MDT based physical therapy
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
functional questionnaire
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Pain scale
Time Frame
3 weeks
Title
Cervical Spine Range of Motion
Description
Active Range of Motion
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Bacon-Baguley, PhD
Organizational Affiliation
Grand Valley State University
Official's Role
Study Chair
Facility Information:
Facility Name
Grand Valley State University
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
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