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

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

Study Overview

• Status: Terminated
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Procedure: Dry needling

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Hobart, Indiana, United States, 46342
      • Integrated therapy Practice PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)	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)
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)
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)

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Investigators: Principal Investigator: Rob Sillevis, PhD, FGCU Assistent Professor

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Dry needling; Manual therapy; Cervicogenic headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: FGCU IRB 2018-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No