Back to resultsEffectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
Primary Purpose
Cervicogenic Headache
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Dry needling, Cervicogenic headache, Manual therapy
Eligibility Criteria
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
Sites / Locations
- Integrated therapy Practice PC
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard care group
Dry needling
Arm Description
Normal manual therapy interventions Clinician will decide normal course of treatment
Dryneedling group Clinician will decide normal course of treatment and dry needling of the Sternocleidomastoid muscle (SCM) muscle will be added to that treatment
Outcomes
Primary Outcome Measures
Change in Headache Disability Index (HDI) score
Questionnaire for self report, this will be on a 0-100 score
Secondary Outcome Measures
Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)
range of motion assessment, this will be measured in degrees with standardized goniometer measure
Change in the neck disability Index score
Self report neck pain questionnaire, This is a 0-100 score
Change in visual analogue scale score
Pain intensity scale,on a 10 cm line patient is asked to mark pain with one vertical mark
Full Information
NCT ID
NCT03730896
First Posted
October 29, 2018
Last Updated
July 21, 2020
Sponsor
Florida Gulf Coast University
1. Study Identification
Unique Protocol Identification Number
NCT03730896
Brief Title
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
Official Title
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough viable subjects
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida Gulf Coast University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Dry needling, Cervicogenic headache, Manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Random assignment to dry needle group or control group with standard manual therapy interventions
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care group
Arm Type
No Intervention
Arm Description
Normal manual therapy interventions Clinician will decide normal course of treatment
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy
Primary Outcome Measure Information:
Title
Change in Headache Disability Index (HDI) score
Description
Questionnaire for self report, this will be on a 0-100 score
Time Frame
At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Secondary Outcome Measure Information:
Title
Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)
Description
range of motion assessment, this will be measured in degrees with standardized goniometer measure
Time Frame
At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Title
Change in the neck disability Index score
Description
Self report neck pain questionnaire, This is a 0-100 score
Time Frame
At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Title
Change in visual analogue scale score
Description
Pain intensity scale,on a 10 cm line patient is asked to mark pain with one vertical mark
Time Frame
At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Sillevis, PhD
Organizational Affiliation
FGCU Assistent Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated therapy Practice PC
City
Hobart
State/Province
Indiana
ZIP/Postal Code
46342
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches
We'll reach out to this number within 24 hrs