Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches

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.
 
ClinicalTrials.gov Identifier: NCT03730896
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Florida Gulf Coast University

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 5, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
Change in Headache Disability Index (HDI) score [ Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42) ]
Questionnaire for self report, this will be on a 0-100 score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT) [ Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42) ]
    range of motion assessment, this will be measured in degrees with standardized goniometer measure
  • Change in the neck disability Index score [ Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42) ]
    Self report neck pain questionnaire, This is a 0-100 score
  • Change in visual analogue scale score [ Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42) ]
    Pain intensity scale,on a 10 cm line patient is asked to mark pain with one vertical mark
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
Official Title  ICMJE Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial
Brief Summary Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches.
Detailed Description

The purpose of this study is to determine whether individuals with cervicogenic headache respond favorably to a program of manual therapy in combination with dry needling of the major muscle between chest bone and the head (sternocleidomastoid muscle) compared to manual therapy directed to the upper body quadrant alone.

The researchers will conduct a randomized clinical trial to assess the effectiveness of a manual therapy and dry needling approach (group 1) vs. manual therapy only. (group 2)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Random assignment to dry needle group or control group with standard manual therapy interventions
Primary Purpose: Treatment
Condition  ICMJE Cervicogenic Headache
Intervention  ICMJE Procedure: Dry needling
Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy
Study Arms  ICMJE
  • No Intervention: standard care group
    Normal manual therapy interventions Clinician will decide normal course of treatment
  • Experimental: Dry needling
    Dryneedling group Clinician will decide normal course of treatment and dry needling of the Sternocleidomastoid muscle (SCM) muscle will be added to that treatment
    Intervention: Procedure: Dry needling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2018)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2019
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 18-65 years old
  2. Primary complaint of cervicogenic headache
  3. Restricted cervical Range of motion
  4. Neck Disability Index > 20 points

Exclusion Criteria:

  1. Red flags identified during the patients physical therapy initial evaluation (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
  2. Use of blood thinners
  3. History of whiplash injury within the past six weeks
  4. Evidence of central nervous system 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, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
  5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    1. Muscle weakness involving a major muscle group of the upper extremity
    2. Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
    3. Diminished or absent sensation to pinprick in any upper extremity dermatome
  6. Prior surgery to the neck or thoracic spine
  7. Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 6-months
  8. Workers compensation or pending legal action regarding their headaches
  9. Insufficient English language skills to complete all questionnaires
  10. Inability to comply with treatment and follow-up schedule
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rob Sillevis, PhD 239-257-1431 rsillevis@fgcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03730896
Other Study ID Numbers  ICMJE FGCU IRB 2018-49
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Florida Gulf Coast University
Study Sponsor  ICMJE Florida Gulf Coast University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rob Sillevis, PhD FGCU Assistent Professor
PRS Account Florida Gulf Coast University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP