NCT05212844

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

December 17, 2021

Last Update Submit

January 14, 2022

Conditions

Keywords

Cervicogenic HeadacheMcKenzieNeck Pain

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline and 6 weeks

  • 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".

    Baseline and 6 weeks

  • 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.

    Baseline and 6 weeks

Interventions

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

Also known as: Mechanical Diagnosis and Treatment

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Received nerve block or Botox injections during therapy
  • Vertigo with nystagmus is present
  • Involved in litigation related to headache complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faith Regional Rehabilitation Therapies

Norfolk, Nebraska, 68701, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 10219926BACKGROUND
  • 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.

    PMID: 14979299BACKGROUND
  • 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.

    PMID: 10234466BACKGROUND
  • 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.

    PMID: 15040968BACKGROUND
  • 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.

    PMID: 8568424BACKGROUND
  • Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.

    PMID: 22034615BACKGROUND

MeSH Terms

Conditions

Post-Traumatic HeadacheNeck Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ronal Schenk, PhD

    Tufts University

    STUDY DIRECTOR

Central Study Contacts

Ronald Schenk, PhD

CONTACT

Eric Miller, DSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 28, 2022

Study Start

December 17, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations