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Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache

This study is currently recruiting participants.
Verified May 2017 by James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
Sponsor:
ClinicalTrials.gov Identifier:
NCT02373605
First Posted: February 27, 2015
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
  Purpose
The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Condition Intervention
Cervicogenic Headaches Other: Dry Needling,Thrust Manipulation Other: Exercise,Non-thrust Mobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture:

Primary Outcome Measures:
  • Change in Headache Intensity (NPRS) (Rating Score) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
    Rating Score. Baseline score must exceed 2/10 to be included in the study.

  • Change in Headache Frequency (Number of headaches in the last week) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
    Number of headaches in the last week

  • Change in Disability (NDI 0-50 points) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
    10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study.


Secondary Outcome Measures:
  • Change in Global Rating of Change Score [ Time Frame: 1 week, 4 weeks, 3 months ]
  • Change in Medication Intake (Frequency of medication intake in last week) [ Time Frame: Baseline, 3 months ]
  • Change in Headache Duration (Total hours of headaches in the last week) [ Time Frame: Baseline, 1 week, 4 weeks, 3 months ]
    Total hours of headaches in the last week


Estimated Enrollment: 110
Study Start Date: February 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dry Needling,Thrust Manipulation Other: Dry Needling,Thrust Manipulation
HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.
Other Names:
  • Spinal Manipulation
  • Dry Needling
Active Comparator: Exercise,Non-thrust Mobilization Other: Exercise,Non-thrust Mobilization
Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.
Other Names:
  • Exercise
  • Non-thrust Mobilization

Detailed Description:
Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
  2. Headache frequency of at least one per week for a minimum of 3 months
  3. Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

Exclusion Criteria:

  1. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
  2. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
  3. History of whiplash injury within the last 6 weeks
  4. Diagnosis of cervical stenosis
  5. Bilateral upper extremity symptoms
  6. Evidence of CNS involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
  7. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:

    1. Muscle weakness involving a major muscle group of the upper extremity.
    2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
    3. Diminished or absent sensation to pinprick in any UE dermatome.
  8. Prior surgery to neck of thoracic spine
  9. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
  10. PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
  11. Any condition that might contraindicate spinal manipulative therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373605


Contacts
Contact: James Dunning, DPT FAAOMPT 801-707-9056 jamesdunning@hotmail.com
Contact: Raymond Butts, DPT PhD 803-422-3954 buttsraymond@yahoo.com

Locations
United States, Alabama
Alabama Physical Therapy & Acupuncture Recruiting
Montgomery, Alabama, United States, 36117
Contact: James Dunning, DPT FAAOMPT    801-707-9056    jamesdunning@hotmail.com   
Contact: Raymond Butts, DPT PhD    803-422-3954    fellowship@spinalmanipulation.org   
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
Principal Investigator: James Dunning, DPT PhD American Academy of Manipulative Therapy
  More Information

Responsible Party: James Dunning, DPT, MSc, FAAOMPT, DPT MSc FAAOMPT, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier: NCT02373605     History of Changes
Other Study ID Numbers: AAMT0001
First Submitted: February 10, 2015
First Posted: February 27, 2015
Last Update Posted: May 25, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases