Clinical trial NCT03730896: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Dry needling
Cervicogenic headache
Manual therapy
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Change in Headache Disability Index (HDI) score
timeFrame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Secondary outcomes:
measure: Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)
timeFrame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
measure: Change in the neck disability Index score
timeFrame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
measure: Change in visual analogue scale score
timeFrame: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)
Other outcomes:
Locations:
city: Hobart
country: United States
facility: Integrated therapy Practice PC
state: Indiana
Study officials:
affiliation: FGCU Assistent Professor
name: Rob Sillevis, PhD
role: PRINCIPAL_INVESTIGATOR
References: