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

NCT03730896 | Terminated

• 1 other identifier: FGCU IRB 2018-49
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervicogenic Headache

Keywords

Dry needling; Cervicogenic headache; Manual therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)

  At initial evaluation (day 1), week three (day 21) and week 6 (day 42)

• Change in the neck disability Index score

  At initial evaluation (day 1), week three (day 21) and week 6 (day 42)

• Change in visual analogue scale score

  At initial evaluation (day 1), week three (day 21) and week 6 (day 42)

Study Arms (2)

standard care group

NO INTERVENTION

Normal manual therapy interventions Clinician will decide normal course of treatment

Dry needling

EXPERIMENTAL

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

Interventions

Dry needling PROCEDURE

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

Dry needling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years old
• Primary complaint of cervicogenic headache
• Restricted cervical Range of motion
• Neck Disability Index \> 20 points

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Gulf Coast University: lead

Study Sites (1)

Integrated therapy Practice PC

Hobart, Indiana, 46342, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Rob Sillevis, PhD

  FGCU Assistent Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Random assignment to dry needle group or control group with standard manual therapy interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 5, 2018
• Study Start: October 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)