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Dry Needling for Cervicogenic Headache

Primary Purpose

Headache, Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Upper extremity stretching program
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Headache, Dry Needling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling and upper extremity stretching program Arm

Dry Needling Arm

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2020
Last Updated
May 18, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT04305223
Brief Title
Dry Needling for Cervicogenic Headache
Official Title
Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Cervicogenic Headache
Keywords
Headache, Dry Needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blinded randomized clinical trial
Masking
Outcomes Assessor
Masking Description
Investigators assessing outcome measures will be blinded to participants' group assignment.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling and upper extremity stretching program Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Dry Needling Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Other Intervention Name(s)
Myofascial trigger point dry needling, Intramuscular stimulation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Upper extremity stretching program
Intervention Description
A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter
Primary Outcome Measure Information:
Title
Change in visual analog score for pain level
Description
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.
Time Frame
Baseline, Weeks 1 to 4 post intervention
Title
Change in pain pressure threshold (PPT)
Description
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.
Time Frame
Baseline, Weeks 1 to 4 post intervention
Title
Change in cervical range of motion
Description
Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).
Time Frame
Baseline, Weeks 1 to 4 post intervention
Title
Functional outcome measure: Change in neck disability index
Description
Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.
Time Frame
Baseline, Weeks 1 to 4 post intervention
Title
Functional outcome measure: Change in headache disability index
Description
Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.
Time Frame
Baseline, Weeks 1 to 4 post intervention
Title
Change in Pain Frequency-Severity-Duration (PFDS) Scale
Description
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.
Time Frame
Baseline, Weeks 1 to 4 post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Geist, PT, DPT
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Dry Needling for Cervicogenic Headache

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