Dry Needling for Cervicogenic Headache

Not Applicable

Completed

• Conditions: Cervicogenic Headache; Headache
• Interventions: Procedure: Dry Needling; Other: Upper extremity stretching program

• Registration Number: NCT04305223
• Lead Sponsor: Emory University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry needling and upper extremity stretching program Arm	Upper extremity stretching program	Participants will receive a combination of dry needling and upper extremity stretching. * Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin America, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes. * A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter.
Dry Needling Arm	Dry Needling	Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin American, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes.
Dry needling and upper extremity stretching program Arm	Dry Needling	Participants will receive a combination of dry needling and upper extremity stretching. * Dry needling in regions of the head and cervical spine will be positioned supine, sidelying or prone with the relevant myofascial trigger points treated using a Seirin L- type 30 mm needle (Seirin America, Inc., Weymouth, MA). The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 5 minutes. * A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter.

Primary Outcome Measures

Name	Time	Method
Change in visual analog score for pain level	Baseline, Weeks 1 to 4 post intervention	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.
Change in pain pressure threshold (PPT)	Baseline, Weeks 1 to 4 post intervention	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.
Change in Pain Frequency-Severity-Duration (PFDS) Scale	Baseline, Weeks 1 to 4 post intervention	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.
Change in cervical range of motion	Baseline, Weeks 1 to 4 post intervention	Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).
Functional outcome measure: Change in neck disability index	Baseline, Weeks 1 to 4 post intervention	Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.
Functional outcome measure: Change in headache disability index	Baseline, Weeks 1 to 4 post intervention	Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States