Dry Needling for Cervicogenic Headache

Headache Clinical Trial

Official title:

Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305223
• Other study ID #: IRB00114985
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.

Description:

This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.

The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unilateral headache (HA) without side shift

• H/o pain triggered by neck movement

• Limitation in cervical range of motion

• Ispilateral neck, shoulder or arm pain

• Intermittent pain with episodes varying in duration

• Head and neck pain is non-throbbing in nature

Exclusion Criteria:

• Use of anti-coagulation medicine (except low dose aspirin)

• Pregnancy

• Acute or uncontrolled medical illness

• Opioid use within six months

• Fibromyalgia or diffuse painful syndromes in the UE or LE

• Substance abuse

• Presence of fever, vomiting or visual changes

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Procedure:
• Dry Needling
Dry Needling is a treatment technique whereby a sterile, single-use, fine filament needle is inserted into the muscle to assist with decreasing pain and improving function through the release of myofascial trigger points (knots in the muscle).

Other:
• Upper extremity stretching program
A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual analog score for pain level	Pain is reported using a Visual Analog Scale from 0-10 and evaluates the frequency, severity and duration of the pain. Higher score indicates worse outcome.	Baseline, Weeks 1 to 4 post intervention
Primary	Change in pain pressure threshold (PPT)	Pressure algometry is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. Measured with a pressure algometer: 0-50 KPa/s (kilopascal/second squared), minimum score representing increased pain to light touch/measuring allodynia.	Baseline, Weeks 1 to 4 post intervention
Primary	Change in cervical range of motion	Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).	Baseline, Weeks 1 to 4 post intervention
Primary	Functional outcome measure: Change in neck disability index	Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.	Baseline, Weeks 1 to 4 post intervention
Primary	Functional outcome measure: Change in headache disability index	Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.	Baseline, Weeks 1 to 4 post intervention
Primary	Change in Pain Frequency-Severity-Duration (PFDS) Scale	PFSD scale ranges from 1-140 with higher scores indicative of higher disability.; There is a composite score that ranges from 0-140. Higher score correlates with worse outcome.	Baseline, Weeks 1 to 4 post intervention