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

Cervicogenic Headache Clinical Trial

Official title:

Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03730896
• Other study ID #: FGCU IRB 2018-49
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2020
• Source: Florida Gulf Coast University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

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

Locations

Country	Name	City	State
United States	Integrated therapy Practice PC	Hobart	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Florida Gulf Coast University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Disability Index (HDI) score	Questionnaire for self report, this will be on a 0-100 score	At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Secondary	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	At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Secondary	Change in the neck disability Index score	Self report neck pain questionnaire, This is a 0-100 score	At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Secondary	Change in visual analogue scale score	Pain intensity scale,on a 10 cm line patient is asked to mark pain with one vertical mark	At initial evaluation (day 1), week three (day 21) and week 6 (day 42)