Headaches, Tension Clinical Trial
Official title:
Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
| NCT number | NCT03142945 |
| Other study ID # | GrandVSU |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 15, 2017 |
| Est. completion date | December 30, 2017 |
| Verified date | August 2018 |
| Source | Grand Valley State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | December 30, 2017 |
| Est. primary completion date | December 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Grand Valley State University | Grand Rapids | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Grand Valley State University | Mary Free Bed Rehabilitation Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neck Disability Index | functional questionnaire | 3 weeks | |
| Secondary | Numeric Pain Rating Scale | Pain scale | 3 weeks | |
| Secondary | Cervical Spine Range of Motion | Active Range of Motion | 3 weeks |