Headaches, TensionNCT03142945
Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
A study testing Traditional Physical Therapy and MDT based physical therapy in people with Headaches, Tension, run by Grand Valley State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headaches, Tension
- What is being tested?
- Traditional Physical Therapy and MDT based physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Valley State University
Grand Rapids, Michigan, 49503
About this study
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.
Read the 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.
- Conditions
- Headaches, Tension
- Being tested
- Traditional Physical Therapy, MDT based physical therapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical TherapyOther
Physical therapy-based interventions
MDT based physical therapyOther
MDT based physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy Group | Active comparator | Traditional Physical Therapy Group Physical therapy-based interventions: home exercises (not repeated motions), stretching, modalities, and posture instruction. Receives: 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. Receives: Other: MDT based physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
functional questionnaire
Measured: 3 weeks
Secondary outcomes (2)
Numeric Pain Rating Scale
Pain scale
Measured: 3 weeks
Cervical Spine Range of Motion
Active Range of Motion
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start15 May 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headaches, TensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Valley State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mary Free Bed Rehabilitation Hospital
- Responsible party
- Principal investigator, Daniel Vaughn, Grand Valley State University
- Investigators
- Theresa Bacon-Baguley, PhD, Study chair, Grand Valley State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142945
- Sponsor's protocol ID
- GrandVSU
- Status last verified
- Aug 2018
- First submitted
- 25 Apr 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Diagnosis and Therapy vs Traditional Physical Therapy in the Treatment of Mechanical Headaches
- ClinicalTrials.gov ID
- NCT03142945
- Acronym / sponsor ID
- GrandVSU
- Conditions
- Headaches, Tension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Grand Valley State UniversityUniversity, hospital or other
- Collaborators
- Mary Free Bed Rehabilitation Hospital
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two randomized groups. One receiving traditional physical therapy treatments for patients with mechanical headaches. The other will receive an MDT- based approach.
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy Group | Active comparator | Other: Traditional Physical TherapyTraditional Physical Therapy Group Physical therapy-based interventions: home exercises (not repeated motions), stretching, modalities, and posture instruction. |
| MDT based physical therapy | Experimental | Other: MDT based physical therapyMDT based physical therapy Physical therapy-based interventions: home exercises (including repeated motions), stretching, modalities, and posture instruction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Physical TherapyPhysical therapy-based interventions | Other | Traditional Physical Therapy Group |
| MDT based physical therapyMDT based physical therapy | Other | MDT based physical therapy |
Primary outcome
Neck Disability Index
Time frame: 3 weeks
functional questionnaire
2 secondary outcomes
Numeric Pain Rating Scale
Time frame: 3 weeks
Cervical Spine Range of Motion
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Bacon-Baguley, PhD study chair
Grand Valley State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and MDT based physical therapy in people with Headaches, Tension, run by Grand Valley State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.