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Clinical Trials/NCT04305223
NCT04305223CompletedNot Applicable

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

Emory University1 site in 1 country7 target enrollmentStarted: February 12, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
1
Primary Endpoint
Change in visual analog score for pain level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Investigators assessing outcome measures will be blinded to participants' group assignment.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dry needling and upper extremity stretching program Arm

Experimental

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.

Intervention: Dry Needling (Procedure)

Dry needling and upper extremity stretching program Arm

Experimental

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.

Intervention: Upper extremity stretching program (Other)

Dry Needling Arm

Active Comparator

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: Dry Needling (Procedure)

Outcomes

Primary Outcomes

Change in visual analog score for pain level

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kathleen Geist

Associate Professor

Emory University

Study Sites (1)

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