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

NCT ID: NCT03730896

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-03-01

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)

Conditions

Cervicogenic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard care group

Normal manual therapy interventions Clinician will decide normal course of treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Dry needling

Intervention Type: PROCEDURE

Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy

Interventions

Dry needling

Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Gulf Coast University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rob Sillevis, PhD

Role: PRINCIPAL_INVESTIGATOR

FGCU Assistent Professor

Locations

Integrated therapy Practice PC

Hobart, Indiana, United States

Countries

United States

Other Identifiers

FGCU IRB 2018-49

Identifier Type: -

Identifier Source: org_study_id