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Trial record 5 of 242 for:    Recruiting, Not yet recruiting, Available Studies | Headache

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

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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

Brief Summary:
Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches.

Condition or disease Intervention/treatment Phase
Cervicogenic Headache Procedure: Dry needling Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
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
Official Title: Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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
Procedure: Dry needling
Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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

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

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): NCT03730896


Contacts
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Contact: Rob Sillevis, PhD 239-257-1431 rsillevis@fgcu.edu

Locations
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United States, Indiana
Integrated therapy Practice PC Recruiting
Hobart, Indiana, United States, 46342
Contact: Karen Wyss, DPT    219-945-1538    meywyss@comcast.net   
Principal Investigator: Karen Wyss, DPT         
Sub-Investigator: Rob Sillevis, PHD         
Sub-Investigator: Arie van Duijn, EdD         
Sub-Investigator: Jacqueline van Duijn, DPT         
Sponsors and Collaborators
Florida Gulf Coast University
Investigators
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Principal Investigator: Rob Sillevis, PhD FGCU Assistent Professor

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Responsible Party: Florida Gulf Coast University
ClinicalTrials.gov Identifier: NCT03730896     History of Changes
Other Study ID Numbers: FGCU IRB 2018-49
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Florida Gulf Coast University:
Dry needling
Cervicogenic headache
Manual therapy
Additional relevant MeSH terms:
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Post-Traumatic Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases