- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03730896
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Hobart, Indiana, United States, 46342
- Integrated therapy Practice PC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18-65 years old
- Primary complaint of cervicogenic headache
- Restricted cervical Range of motion
- Neck Disability Index > 20 points
Exclusion Criteria:
- 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.
- Use of blood thinners
- History of whiplash injury within the past six weeks
- 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.
Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Muscle weakness involving a major muscle group of the upper extremity
- Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
- Diminished or absent sensation to pinprick in any upper extremity dermatome
- Prior surgery to the neck or thoracic spine
- Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 6-months
- Workers compensation or pending legal action regarding their headaches
- Insufficient English language skills to complete all questionnaires
- Inability to comply with treatment and follow-up schedule
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: standard care group
Normal manual therapy interventions Clinician will decide normal course of treatment
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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
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Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Headache Disability Index (HDI) score
Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Questionnaire for self report, this will be on a 0-100 score
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At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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range of motion assessment, this will be measured in degrees with standardized goniometer measure
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At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Change in the neck disability Index score
Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Self report neck pain questionnaire, This is a 0-100 score
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At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Change in visual analogue scale score
Time Frame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Pain intensity scale,on a 10 cm line patient is asked to mark pain with one vertical mark
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At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rob Sillevis, PhD, FGCU Assistent Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FGCU IRB 2018-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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