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Cervicogenic HeadacheNCT05212844

McKenzie Method of Mechanical Diagnosis and Therapy for Management of Cervicogenic Headache: A Prospective Case Series

An observational study of Cervicogenic Headache, run by Faith Regional Health Services at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this study is to examine the effectiveness the Mechanical Diagnosis and Therapy (MDT) approach for the management patients with neck related headache that are referred to a hospital based out-patient physical therapy clinic. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Cervicogenic Headache
What is being tested?
Musculoskeletal Physical Therapy
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteUnited States
Study dates
17 Dec 2021to 31 Jul 2022
Phase
Observational
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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A sample of 15-20 subjects is expected. Subjects referred to physical therapy by their physician and meeting the inclusion criteria will be recruited for participation.

Who may be able to join

  • Age 19-70
  • During the physical therapy examination, it is found that movements, static positions, or postures affect the patient headache symptoms.
  • Pain presents as unilateral or bilateral head/neck pain and/or stiffness
  • Headache frequency at least 1x/week
  • Headache symptoms are present for at least 3 months
  • Dizziness and/or tinnitus affected by neck movements or positions
  • Patient has been previously screened for their headache symptoms by their MD

Who cannot join

  • Headache is determined to be of non-cervical origin including migraine, cluster headache, tension-type headache
  • Malignancy/infection
  • Cranial or cervical vascular disorder
  • Substance use or withdrawal
  • Acute Post cervical surgery
  • Psychosis/psychiatric disorder/post-traumatic stress disorder
Show all 9Show fewer
  • Received nerve block or Botox injections during therapy
  • Vertigo with nystagmus is present
  • Involved in litigation related to headache complaints

Trial locations and contacts

1 site in 1 country.

Ronald Schenk, PhD contact

716-566-8756

ronald.schenk@tufts.edu

Eric Miller, DSc contact

716-912-9046

millere@dyc.edu

United States1 site, 1 recruiting

  • Faith Regional Rehabilitation Therapies

    Norfolk, Nebraska, 68701

    Lin Pu, PT, 402-644-7396, ptlin@hotmail.com

    Recruiting

Other trials in United States

About this study

Official title: Utilizing the McKenzie Method of Mechanical Diagnosis and Therapy for Management of Cervicogenic Headache: A Prospective Case Series

The goal of this study is to examine the effectiveness the Mechanical Diagnosis and Therapy (MDT) approach for the management patients with neck related headache that are referred to a hospital based out-patient physical therapy clinic.

Background: Headache conditions are among the most common complaints causing people to seek medical care. An estimated 14 billion dollars are spent annually on treating headaches. Neck related headache is characterized by pain which comes from the cervical spine (neck) and could be referred to the head and/or face. CGH is frequently managed clinically utilizing an MDT approach however to date there is limited research available examining the effectiveness of this intervention type in a population with CGH.

Read the detailed description

Objective: The goal of this case-series is to examine the effectiveness the Mechanical Diagnosis and Therapy (MDT) approach for the management patients with cervicogenic headache referred to a hospital based out-patient physical therapy clinic.

Design: Prospective consecutive case series.

Background: Headache conditions are among the most common complaints causing people to seek medical care. An estimated 14 billion dollars are spent annually on treating headaches. Cervicogenic headache (CGH) is described as a secondary type of headache characterized by pain which emanates from the cervical spine and is potentially referred to one or more regions of the head and/or face. CGH is frequently managed clinically utilizing an MDT approach however to date there is limited research available examining the effectiveness of this intervention type in a population with CGH.

Study Selection Criteria: Convenience sampling will be utilized. Subjects diagnosed with CGH and meeting inclusion criteria will be recruited from a population of patients referred by their physician to a hospital based out-patient physical therapy clinic for treatment.

Procedures: Subjects meeting inclusion criteria will be evaluated, classified, and receive interventions based on the MDT approach. Outcome measures utilized will include the Neck Disability Index (NDI), Numeric Pain Rating Scale (NRS), and Headache Disability Index (HDI) will be completed at baseline, visit 5, and visit 10 or discharge, whichever comes first.

Data Management: Descriptive statistics will be used to describe sample characteristics. A repeated measures ANOVA will be utilized to identify changes in group means.

Key Words: Cervicogenic Headache, Mechanical Diagnosis and Treatment.

Being tested
Musculoskeletal Physical Therapy
Keywords
Cervicogenic Headache, McKenzie, Neck Pain
Medical subject headings
Post-Traumatic Headache, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Musculoskeletal Physical TherapyProcedure or surgery

    Also called Mechanical Diagnosis and Treatment

    Therapeutic exercise and manual physical therapy based on the individual response to end range repeated movements.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Neck Disability Index (NDI) Scores to Discharge

    The NDI measures the patient perceived level of function related to neck pain. The NDI is a 10 item questionnaire scored from 0-50 with higher scores indicating greater levels of disability.

    Measured: Baseline and 6 weeks

  2. Change from Baseline in Numeric Pain Rating Scale (NPRS) Scores to discharge

    The NPRS is an 11 item numeric scale that provides a patient rating of neck pain and headache symptoms. The scales corelates with a score of 0 indicating "no pain" and 10 indicating the "worst pain imaginable".

    Measured: Baseline and 6 weeks

  3. Change from Baseline in Headache Disability Index (HDI) Scores to Discharge

    The HDI measures the patient perceived level of pain and disability related to headache symptoms. The HDI is a 25 item questionnaire scored from 0-100 with a higher score indicating a greater level of disability related to the patient headache symptoms.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start17 Dec 2021
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212844
Sponsor's protocol ID
081468
Status last verified
Jan 2022
First submitted
17 Dec 2021
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If data is shared it would be deidentified data reported in aggregate format only.

Publications

  • Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med. 1999 Apr 26;159(8):813-8. doi: 10.1001/archinte.159.8.813.

    PubMed 10219926

  • Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.

    PubMed 14979299

  • Jull G, Barrett C, Magee R, Ho P. Further clinical clarification of the muscle dysfunction in cervical headache. Cephalalgia. 1999 Apr;19(3):179-85. doi: 10.1046/j.1468-2982.1999.1903179.x.

    PubMed 10234466

  • Jull G, Kristjansson E, Dall'Alba P. Impairment in the cervical flexors: a comparison of whiplash and insidious onset neck pain patients. Man Ther. 2004 May;9(2):89-94. doi: 10.1016/S1356-689X(03)00086-9.

    PubMed 15040968

  • Nilsson N. A randomized controlled trial of the effect of spinal manipulation in the treatment of cervicogenic headache. J Manipulative Physiol Ther. 1995 Sep;18(7):435-40.

    PubMed 8568424

  • Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.

    PubMed 22034615

Questions about this trial

What is this clinical trial studying?

An observational study of Cervicogenic Headache, run by Faith Regional Health Services 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ronald Schenk, PhD (716-566-8756, ronald.schenk@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Neck Disability Index (NDI) Scores to Discharge (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05212844, which also lists 6 linked publications.

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 28 Jan 2022.

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